Assignment: Theoretical Foundation for Research Paper: Partial Draft

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Theoretical Foundation for Research

Name

Walden University

Advanced Theoretical and Scientific Perspectives in Nursing

Theoretical Foundation for Research

Introduction

Fear of needles is a significant barrier to medical treatment observed by healthcare providers. Sahin and Eser (2018) noted that adults experience injection anxiety due to the perception of expected needle pain. In one study, 30.6% of adult patients reported needle fear (Celek & Khorshid, 2015). In 2016, The World Health Organization (2019) revised the significance of injections as one of the most common medical procedures in the world: 16 billion injections worldwide annually, 90-95% therapeutic injections, and 5-10% immunizations and other injections. McLenon and Rogers (2018) researched needle fear with a meta-analysis and determined the prevalence to approximate 20-30% of adults aged 20-40 years of age. The prevalence of needle fear was greater for females at all age ranges regardless of geographic area (McLenon and Rogers, 2018). Awareness and consideration of this practice problem by healthcare providers performing injections is an essential step towards improved patient outcomes.

Injections are common procedures in the aesthetic industry for adult patients. The American Society of Aesthetic Plastic Surgery (2019) publishes an annual report for both surgical and nonsurgical cosmetic procedures. According to the latest published data, the organization reports over 2.6 million cosmetic injections in the U. S. in 2018 (ASAPS, 2019).

This is an increase of 38.7% from 2014 to 2018 (ASAPS, 2019). Adult women aged 18 years and older represent 92.3% of the cosmetic injection market (ASAPS). As previously stated, McLenon and Rodgers (2018) found females of all ages have a higher incidence of needle fear compared to males. Although these patients may represent a small portion of the annual medical injections as established by the World Health Organization (2019), a percentage of female patients receiving cosmetic injections represent a population experiencing fear related to needles. The purpose of this paper is to outline a concept analysis of a selected concept.

Phenomenon of Interest

The phenomenon of interest is described as the focus of a study or central issue (Gray, Grove, & Sutherland, 2017). When we encounter problems or questions that bother us and that which we want to know more about without the lack of good answers in the research, the issue becomes a research topic or phenomenon of interest (Laureate Education, 2014).

The phenomenon of interest for this assignment is identified as needle fear in the context of adult patients receiving cosmetic injections. The prevalence of the phenomenon of needle fear in the general population has been identified in the existing literature (McLenon & Rogers, 2018). The number of cosmetic injection treatments was estimated in the U. S. in 2018 and determined to be increasing annually (ASAPS, 2019). I have selected the phenomenon as I encounter this daily with aesthetic patients in my practice. As a provider, I want to understand this phenomenon that influences these patients and their experience with treatments requiring needles/injection.

Concept

Walker and Avant (2019) describe concepts as the basic building blocks in constructing theory. A concept is a mental image of an idea, person, object, or phenomenon that provides understanding and clear communication (Walker & Avant, 2019). Concrete concepts are observable with identifiable empirical referents (McEwen & Wills, 2019). Abstract concepts are not directly observable and must be defined for the purpose of measurement and quantifying results in research (McEwen & Wills, 2019). The selected concept related to the phenomenon of interest is needle fear.

Definition

The objective of concept definition is to provide meaning to an idea that promotes understanding, communication, consistency of use, clarity, and structure (Gray, Grove, & Sutherland, 2017; Walker & Avant, 2019). Concepts must be defined so that research design is appropriate, and the means of measurement are valid (Cronin, Ryan, & Coughlan, 2010). Concept definition allows anyone who sees the concept and its function within a theory, the ability to understand precisely what is described, explained, or predicted (Walker & Avant, 2019).

Concepts are narrow in focus (Laureate Education 2014). The process of concept definition should focus on the concept not the context and exploration should take place outside the field of nursing (Laureate Education, 2014).

Merriam-Webster (2019) defines the noun, fear, in the following ways: 1) an unpleasant often strong emotion caused by anticipation or awareness of danger, 2) anxious concern, 3) profound reverence and awe especially toward God, and 4) reason for alarm. Interestingly, the online dictionary gives a medical definition of fear: an unpleasant often strong emotion caused by anticipation or awareness of danger and accompanied by increased autonomic activity (Merriam-Webster, 2019).

Needle is defined by Merriam-Webster (2019): a slender, hollow instrument for introducing material into or removing material from the body as by insertion under the skin.

In summary, needle fear is defined as an unpleasant often strong emotion caused by the anticipation or awareness of the use of a needle for insertion or injection under the skin.

Review of Literature

The review of literature was conducted to examine the existing, peer-reviewed literature related to the concept of fear in general and for specific context, the concept of needle fear. Review of the literature included various databases: MEDLINE, CINAHL, EMBASE, Google Scholar, EBSCO, and ProQuest. Searches were performed on the general term of fear and specific to the context of needles. Keywords included the following search terms: “fear”, “injections”, “needle”, “treatment”, “lab work”, “blood draw”, “blood donation”, “dental”, “blood”, “acupuncture”, and “diabetes”. The Boolean operators of “and” and “or” were used to guide the search. Scholarly peer-reviewed journals were selected for the electronic literature review. Definition of the concept through the existing literature uncovered use in diverse disciplines: cognitive behavior, dentistry, medicine, neuroscience, nursing, philosophy, and psychology.

Cognitive Behavior

McMurty et al. (2016) researched exposure-based interventions on the influence of needle fear from childhood across the lifespan. These researchers emphasized that the concept of fear begins in childhood and can become chronic affecting individuals throughout life (McMurty et al., 2016). The authors discussed health-related issues and the avoidance of health care related to needle fear (McMurtry et al., 2016).

Cognitive behavior therapy interventions were researched to reduce the fear of pain with intravenous cannulation in a sample population of children (Hsieh et al., 2017). Hsieh et al. (2017) conducted a quasi-experimental design using a cognitive-behavioral program to evaluate pain perception in 68 school-aged children receiving intravenous placement. The mean scores on pain and fear decreased in the experimental group but only fear scores were statistically different from control (Hsieh et al., 2017).

Dentistry

Dental fear has associations with needle fear as significant treatment includes the use of needles. Carter, AlShwaimi, Boschen, Carter, and George (2019) studied the perception of fear and anxiety associated with dental procedures related to cultural influences and the pathways of fear development. The researchers used purposive sampling of 285 adults undergoing dental procedures (Carter et al., 2019). The participants completed a questionnaire to rate factors that may have caused dental fear and anxiety (Carter et al., 2019). Findings indicated three predominant pathways related to the development of fear: verbal threat, parental influence, and conditioning experiences (Carter et al., 2019).

Medicine

The medical research literature examined the concept of fear related to medical treatment requiring the use of a needle: anesthesia intravenous cannulation before surgery (Karaman et al., 2016), vaccinations and the development of fear through conditioning (McMurtry et al., 2015),

venipuncture (Vijayan, Scott, Brownlie, Male & Chin, 2015), and the fear of pain related to diabetes management and injectable medications (Kruger, LaRue, & Estepa, 2015).

Karaman et al. (2016) evaluated the effectiveness of lavender aromatherapy on patients undergoing intravenous insertion prior to surgery. The researchers used a prospective, randomized, single-blind, placebo-controlled study design with a total of 106 adult patients (Karaman et al., 2016). Findings demonstrated a statistically significant decrease in both pain and anxiety in the intervention group receiving aromatherapy compared with the control group (Karaman et al., 2016).

Researchers provided a discussion of needle fear related to childhood vaccinations: etiology, prevalence, course, consequences, discussion of concepts, and management (McMurtry et al., 2015).

Kruger et al. (2015) noted that anxiety and fear of injection-associated pain was estimated to affect 30%-50% of patients before initiating diabetic education interventions. The researchers emphasized that practitioners can reduce barriers to injectable treatment for type 2 diabetes through strategies to minimize injection-associated fear and anxiety (Kruger et al., 2015).

Vijayan et al. (2015) used a randomized trial to evaluate the use of verbal warnings given by healthcare providers before venipuncture. Most patients preferred verbal warnings before venipuncture rather than no verbal warning (Vijayan et al., 2015).

Neuroscience

The development of fear, fear conditioning, and fear generalization were the concepts analyzed concerning the concept of fear (Asok, Kandel, & Rayman, 2019). Asok et al. (2019) presented a discussion regarding fear and the factors associated with the generalization of fear. The authors discussed the generalization of fear memories as an adaptive neurobiological process that secures survival (Asok et al., 2019). Generalization of fear was found to be modulated by intrinsic factors: internal states, previous experience, genetic background, and sex differences (Asok et al., 2019). Extrinsic factors also influenced the generalization of fear: early life stress and environmental elements (Asok et al., 2019). Generalization was found to be sensitive to the passage of time and retained memory (Asok et al., 2019).

Nursing

Nursing research uncovered an abundance of literature related to the concept of fear. In the context of needles, research surrounding intramuscular injections including immunizations was identified in numerous publications (Celek & Khorshid, 2015; Khanra, Asokan, & Lenka, 2018; Redfern, Micham, Seegert, & Chen, 2019; Sahin & Eser, 2018; Sahiner, Inal, & Akbay, 2015).

Celik and Khorshid (2015) found that the use of Shotblocker® for IM injections reduced pain intensity. The study did not demonstrate a significant reduction in level of anxiety measured by the State-Trait Anxiety Inventory form (Celik & Khorshid, 2015). The research included 180 adult patients in an experimental, randomized, double-blind, controlled design with the dependent variable, pain, measured using a visual analog scale (Celik & Khorshid, 2015).

Khanra et al. (2018) evaluated the effectiveness of the Helfer Skin Tap technique on pain associated with intramuscular injections with 60 postoperative patients in an experimental, randomized research design. Findings revealed greater effectiveness on pain reduction with the Tap technique compared with the standard technique (Khanra et al., 2018). Measurement of the dependent pain variable employed a numerical rating scale (Khanra et al., 2018).

Researchers conducted a randomized controlled trial using an intervention involving thermomechanical stimulation in 497 adults receiving influenza immunizations to evaluate pain perception (Redfern et al., 2019). Using a validated measurement tool, study results demonstrated statistically significant reduction in pain with the applied intervention compared with the control (Redfern et al., 2019).

In a randomized controlled trial, researchers investigated the effect of the Buzzy® device on pain perception and patient satisfaction using validated visual analog scales to measure the dependent variables (Sahin & Eser, 2018). Statistical analysis demonstrated two findings within the intervention group compared with the control: Post-injection pain intensity was found to be lower and injection satisfaction was found to be higher (Sahin & Eser, 2018).

Sahiner et al. (2015) conducted a prospective, randomized controlled trial to evaluate pain and anxiety levels in 104 seven-year-olds receiving immunizations. The intervention included a thermomechanical device (Sahiner et al., 2015). The dependent variables of pain and anxiety employed the Wong-Baker FACES and the Children Fear Scale (Sahiner et al., 2015). The experimental group demonstrated significantly lower pain and anxiety compared with the control group (Sahiner et al., 2015).

Fear of procedural pain related to needle insertion of implanted central venous ports in a sample of cancer patients was examined by Yayla and Ozdemir (2019). The researchers conducted a randomized control trial to evaluate the effectiveness of inhalation aromatherapy on pain and anxiety related to needle insertion into an implantable central venous port in 123 cancer patients undergoing chemotherapy (Yayla & Ozdemir, 2019). The Visual Analog Scale was used to measure the attribute of pain and the State Anxiety Inventory was used to measure the attribute of anxiety (Yayla & Ozdemir, 2019). The findings demonstrated significantly lower levels of pain in the group receiving lavender inhalation compared with the control group (Yayla & Ozdemir, 2019). No significant difference between the groups was demonstrated related to anxiety levels (Yayla & Ozdemir, 2019).

McLenon and Rogers (2019) conducted a systematic review and meta-analysis of 35 articles to evaluate prevalence of needle fear and identify characteristics of the phenomenon. The study found that most children exhibited needle fear, the prevalence estimates for adolescents ranged from 20-50%, and the prevalence in young adults ranged from 20-30% (McLenon & Rogers, 2019). The article discussed avoidance of medical care, noncompliance, and significance of needle fear (McLenon & Rogers, 2019).

Philosophy

Ancient Greek philosophers developed the concept of fear to explain the experience of panic and the flight response (Sharkstein, 2016). These philosophers cast a theological connotation of fear: awe and reverence for a divine being (Sharkstein, 2016). Physical symptoms related to the experience of fear were explored by Homer (Sharkstein, 2016). The concept was correlated with anxiety in the philosophical and psychiatric literature in the 19th century by Sigmund Freud (Sharkstein, 2016). More contemporary philosophers emphasized anxiety when exploring the concept of fear (Sharkstein, 2016).

Psychology

Psychologists have researched the concept of fear related to fear learning, fear conditioning, and fear generalization (Dunsmoor & Murphy, 2015; Glogan, van Vliet, Roelandt, and Muelders, 2019).

Dunsmoor & Murphy (2015) discussed fear and fear conditioning. The researchers defined fear conditioning as a stimulus associated with a threat that elicits a specific response which over time may become generalized to other environmental stimuli (Dunsmoor & Murphy, 2015). Higher-order processes such as inductive reasoning and conceptual knowledge are proposed as future study concepts in the generalization of fear (Dunsmoor & Murphy, 2015).

Glogan et al. (2019) studied pain-related fear that led to overgeneralization to safe stimuli which contributed to excessive fear and avoidance behavior. The researchers discussed pain as a strong motivator of fear learning from potential bodily threats (Glogan et al., 2019). Adult volunteers were participants in a study that found that concept-based fear (conceptual relationships between fear inducing stimuli) can be extinguished as a learned behaviour (Glogan et al., 2019).

Others in the field have explored the fear of needles related to the sensory stimuli of blood and the experience of presyncopal symptoms and syncope (Gilchrist, McGovern, Bekkouche, Bacon, & Ditto, 2015; Kowalsky, Conatser, Ritz, & France, 2018; Trost, Jones, Guck, Vervoort, & Kowalsky, 2017).

Researchers studied the vasovagal response during medical procedures involving processes like those observed during episodes of strong emotion and pain (Gilchrist et al., 2015). The randomized controlled trial with 82 adult patients tested the hypothesis that heightened perceived control would reduce the symptoms of the vasovagal response (Gilchrist et al., 2015). The researchers found that patients with no perceived control reported significantly more vasovagal symptoms and anxiety (Gilchrist et al., 2015). Perceived control was found to reduce these symptoms (Gilchrist et al., 2015).

Kowalsky et al. (2018) studied the effects of applied muscle tension as an intervention during a simulated blood draw with 95 adult participants identified as highly fearful of needles. The purpose of the study was to examine the effectiveness of the intervention on presyncopal symptoms (Kowalsky et al., 2018). The study found no significant difference between the intervention group and the control group (Kowalsky et al., 2018).

Researchers used a virtual blood draw paradigm with 74 adults to evaluate the subjects’ perceptions of perceived reality using the model (Trost et al., 2017). The results of the study supported the virtual representation as a learning tool to address anxiety related to blood and needle procedures (Trost et al., 2017).

Antecedents, Attributes, and Consequences

Attributes are the characteristics most associated with the concept in the literature that defines and describes the concept (McEwen, & Wills, 2019; Walker & Avant, 2019). Walker and Avant (2019) emphasized refining attributes to the fewest number possible using the ones that appear frequently. Attributes may change over time (Walker & Avant, 2019). Antecedents precede the concept and are required elements for the concept to exist (McEwen, & Wills, 2019; Walker & Avant, 2019). Consequences result from the occurrence of the concept (Avant & Walker, 2019). Figure 1 summarizes the review of the literature and the identified attributes, antecedents, and consequences related to the concept of needle fear.

Figure 1. Attributes, antecedents, and consequences of the concept needle fear.

Attributes	Antecedents	Consequences
Pain Researchers: Asok et al., 2019; Carter et al., (2019); Celek & Khorshid, 2015; Gilchrist et al., 2015; Glogan, et al., 2019; Hsieh et al., 2017; Karaman et al., 2016; Khanra et al., 2018; McLenon & Rogers, 2019; McMurtry et al., 2016; McMurtry et al., 2015; Redfern et al., 2019; Sahiner et al.,, 2015; Yayla & Ozdemir, 2019.	Prescribed treatments Researchers: Carter et al., 2019; Celek & Khorshid, 2015; Hsieh et al., 2017; Karaman et al., 2016; Khanra et al., 2018; McLenon & Rogers, 2019; Kowalsky et al., 2018; McMurtry et al., 2016; McMurtry et al., 2015; Redfern et al., 2019; Sahiner et al., 2015; Yayla & Ozdemir, 2019	Negative biopsychosocial outcomes Researchers: McLenon & Rogers, 2019; McMurtry et al., 2016; McMurtry et al., 2015; Redfern et al., 2019; Sahiner et al., 2015; Yayla & Ozdemir, 2019.
Anxiety Researchers: Asok et al., 2019; Carter et al., 2019; Celek & Khorshid, 2015; Gilchrist et al., 2015; Karaman et al., 2016; McMurtry et al., 2016; McMurtry et al., 2015; Redfern et al., 2019; Sahiner et al., 2015; Trost et al., 2017; Yayla & Ozdemir, 2019.	Conditioned experiences Researchers: Asok et al., 2019; Carter et al., 2019; Celek & Khorshid, 2015; Dunsmoor & Murphy, 2015; Glogan et al., 2019; Kowalsky et al., 2018; McMurtry et al., 2015; Trost et al., 2017;	Avoidance of care/situation Researchers: Carter et al., 2019; Celek & Khorshid, 2015; Glogan et al., 2019; Kowalsky et al., 2018; McLenon & Rogers, 2019; McMurtry et al., 2016; McMurtry et al., 2015; Redfern et al., 2019; Sahiner et al., 2015; Trost et al., 2017.
	Healthcare provider Researchers: Carter et al., 2019; Celek & Khorshid, 2015; Hsieh et al., 2017; Karaman et al., 2016; Khanra et al., 2018; Kowalsky et al., 2018; McMurtry et al., 2016; McMurtry et al., 2015; Redfern et al., 2019; Sahiner et al., 2015; Trost et al., 2017; Yayla & Ozdemir, 2019.	Noncompliance Researchers: McLenon & Rogers, 2019; McMurtry et al., 2016; McMurtry et al., 2015; Redfern et al., 2019; Sahiner et al., 2015; Yayla & Ozdemir, 2019.
	Patient perceived lack of Control Researchers: Gilchrist et al., 2015.

Definition Summary

The concept of fear for this theoretical foundation is defined as an acquired, learned, and conditioned response to a stimulus that is associated with an unpleasant outcome (Dunsmoor & Murphy, 2015; Glogan, van Vliet, Roelandt, & Muelders, 2019). The stimulus (context) within the concept is needles. The concept, needle fear, is abstract as described by McEwen and Wells (2019). The definition of needle fear is an acquired, learned and conditioned response to the stimulus of a needle that is associated with an unpleasant outcome.

Conceptual Relationships

. The literature review reflected a conditional relationship between the concept of needle fear and avoidance. Walker and Avant (2019) describe this relationship as occurring between two concepts in the presence of a third concept. The relationship is implied as asymmetric and linear in the existing literature. Walker and Avant (2019) describe asymmetrical relationships as one-directional where one concept leads to the next, but the relationship is not reciprocated.

Four concepts were identified from the literature that posed a conceptual relationship: fear of needles, avoidance of medical care, anxiety, and pain perception. The concept of needle fear has been previously defined from the review of the literature. Pain and anxiety were identified as attributes or characteristics of the concept of needle fear. Avoidance of medical care was identified as a consequence of needle fear.

The concept of pain is defined by Merriam-Webster (2019): localized or generalized unpleasant bodily sensation or complex of sensations that causes mild to severe physical discomfort and emotional distress and typically results from bodily disorder (such as injury or disease).

Avoidance is defined by Merriam-Webster (2019): an act or practice of avoiding or withdrawing from something.

Anxiety has been defined in the following ways: 1) apprehensive uneasiness or nervousness usually over an impending or anticipated ill, 2) medical : an abnormal and overwhelming sense of apprehension and fear often marked by physical signs (such as tension, sweating, and increased pulse rate), 3) a mentally distressing concern or interest, and 4) a strong desire sometimes mixed with doubt, fear, or uneasiness (Merriam-Webster, 2019).

In addition to the conditional relationship between fear of needles and avoidance, two modifying variables were reflected in the literature: pain and anxiety. These modifying variables change the strength of the relationship between needle fear and avoidance (Gray, Grove, & Sutherland, 2017). Figure 2 below is a proposed diagram representing the concepts, relationships, and direction.

Figure 2. Conceptual relationships related to the concept of needle fear.

Assumptions

Assumptions represent beliefs (implicit or explicit) about a phenomenon and are accepted as true without proof (McEwen & Wills, 2019). From the review of literature, the following assumptions have been identified within the various disciplines.

1. Past experiences influence present and future response to stimuli.

2. Fear is an adaptive response for survival including the fear of pain.

3. Pain is often associated with needles.

4. Beings avoid the experience of pain as an adaptive, survival response.

Theory

Theories represent beliefs about a situation and consider why a phenomenon occurs, what influences it, and what outcomes it produces (Laureate Education, 2014). Theories describe the phenomenon (what), explain what is occurring and the intervening factors, predict (based on the presence or absence of specific factors), and control outcomes (Laureate Education, 2014). Frameworks are not as developed as theories and do not control outcomes (Laureate Education, 2014). Theories are widely accepted and have been demonstrated in multiple studies (Laureate Education, 2014).

Origin

Ronald Melzack was a Canadian psychologist (Wikipedia, 2019). After receiving his Ph.D. in 1954, he worked with patients who suffered from phantom limb pain (Wikipedia, 2019). He later became a faculty member at the Massachusetts Institute of Technology (MIT) where he met Patrick Wall (Wikipedia, 2019).

Dr, Patrick David Wall was a leading British neuroscientist regarded as a pain expert (Wikipedia, 2019). He attended Oxford University and moved to the United States after treating holocaust survivors (Wikipedia, 2019). Dr. Wall became an instructor at the Yale School of Medicine investigating the use of lobotomies as a method of controlling depression (Wikipedia, 2019). He later became an instructor at Harvard University and became an associate professor at MIT where he met Dr. Melzack (Wikipedia, 2019).

Melzack believed that pain was subjective and multidimensional (Wikipedia, 2019). The two collaborators noted that some individuals felt immense pain when damage to the body was minimal and some people with traumatic injuries experienced little or no pain (Wikipedia, 2019). Ronald Melzack and Patrick D. Wall first published The Gate Control Theory of Pain in 1962 (Katz & Rosenbloom, 2015). The theory described pain as "gated" or modulated by past-experience (Wikipedia, 2019). Gate control theory led to other studies developed by the two researchers: the discovery of endorphins, stress-induced analgesia, and phantom limb pain (Wikipedia, 2019). Dr. Wall later collaborated on the production of the Transcutaneous Nerve Stimulator which validated their paper on the Gate Control Theory (Wikipedia, 2019). Dr. Melzack recently passed away on December 22, 2019 (Wikipedia, 2019).

The Gate Control Theory is considered a biomedical theory. Melzack and Wall’s theory defined a spinal gating mechanism of pain transmission (Katz & Rosenbloom, 2015). Within the dorsal horn of the spinal cord, nerve impulse transmission from afferent fibers to the brain is controlled by a “gate” (Katz & Rosenbloom, 2015). Stimulation of the large diameter afferent fibers inhibit transmission of impulses (close the “gate”) while stimulation of small fibers allows transmission of impulses (open the “gate”) (Katz & Rosenbloom, 2015; McEwen & Wills, 2019). Stimulation of large fibers through various mechanisms can close or partially close the gating mechanism altering the brain’s perception of painful stimuli (Katz & Rosenbloom, 2015; McEwen & Wills, 2019). Melzack and Wall’s theory included not only physiologic factors that affect pain but also psychological factors (anxiety, fear, and depression) that influence transmission of pain (Katz & Rosenbloom, 2015; McEwen and Wills, 2019; Sahin & Eser, 2018).

Application

Melzack and Wall’s theory included not only physiologic factors that affect pain but also psychological, emotional, and behavioral factors (anxiety, fear, and depression) that influence the transmission of pain (Katz & Rosenbloom, 2015; McEwen and Wills, 2019; Sahin & Eser, 2018). The Gate Control Theory can be applied to the attributes of pain and anxiety related to the concept of needle fear. These attributes are stimuli that affect the gating mechanism as described by the researchers (Katz & Rosenbloom, 2015). The concept of needle fear has been researched using the theoretical framework of Gate Control Theory in nursing (Celek & Khorshid, 2015; Khanra et al., 2018; Redfern et al., 2019; Sahin & Eser, 2018; Sahiner et al., 2015).

Research Questions/Hypotheses

The phenomenon of interest is needle fear in the context of the adult cosmetic patient. The adult patient is defined as ≥ 18 years of age. Definition of the concept of fear through the review of literature demonstrated two predominate attributes: pain and anxiety (Aydin & Sahiner, 2017; Celek & Khorshid, 2015; Khanra et al., 2018; McMurtry et al., 2016; Redfern et al., 2019). The operationalized concepts of pain and anxiety were used in multiple studies with validated scales for pain and anxiety (Aydin & Sahiner, 2017; Celek & Khorshid, 2015; Khanra et al., 2018; Redfern et al., 2019; Weiss & Lavin, 2009). The Gate Control Theory was used as the theoretical foundation in many of these studies (Celek & Khorshid, 2015; Khanra et al., 2018; Kuwahara & Ogawa, 2016; Redfern et al., 2019; Sahin & Eser, 2018; Sahiner et al. 2015; Weiss & Lavin, 2009).

Identifying a research question requires that we examine multiple aspects: relationships in the conceptual framework, the literature review of the concepts, the predictors of the outcome, and the interventions to control the outcome (Laureate Education, 2014). We accept theories as true for the foundations of our research (Laureate Education, 2014). Predictive theories are used to predict an expected outcome (Reay & Rankin, 2013). For my phenomenon of interest, I have chosen the Gate Control Theory and my interest is to use an intervention-based, experimental study with this predictive theory. Quantitative research is interventional and there is always a hypothesis, implicit or explicit (Gray, Grove, & Sutherland, 2017). “A hypothesis is a stated relationship between or among variables within a specified population” (Gray et al., 2017, p. 110). The hypothesis makes a statement using the variables at a concrete level with operationalized definitions amenable to measurement (Gray et al., 2017). In quantitative research, the hypothesis may represent a cause and effect relationship between the variables and may pose a directional relationship (Gray et al., 2017). The null hypothesis in research is designated at Ho: no difference exists between the comparisons (Gray et al., 2017). The alternative hypothesis proposes a difference between comparisons in rejection of the null hypothesis: HA (Gray et al., 2017).

For the phenomenon of interest, the following hypothesis is proposed.

Alternative hypotheses (HA):

· Adult, cosmetic injectable patients receiving a pre-injection intervention will experience less pain and anxiety compared with patients receiving routine care.

Graphic Model

The review of literature for the concept is represented by the identification of the concept’s attributes, antecedents, and consequences in Figure 1. The conceptual relationships uncovered in the literature can be represented in diagrammatic form demonstrating direction, shape, and strength (Gray et al., 2017). Intervening or mediating variables can influence strength, occurrence, or direction of a conceptual relationship (Gray et al., 2017). Figure 3 is a proposed graphic model representing the concept of needle fear. Fear was the original concept explored in the concept analysis with the specific context of needles. The review of literature demonstrated two predominate attributes: pain and anxiety that are proposed as mediating variables influencing the relationship between the concept and the consequence. Antecedents were the prescribed needle treatment, the care provider, conditioned experiences, and perceived control. The environment from the nursing paradigm has both intrinsic and extrinsic factors which have been incorporated into the model (McEwen & Wills, 2019). The consequences identified in the literature were noncompliance, avoidance of care/situation, and negative biopsychosocial outcomes. The Gate Control Theory has been selected as the guiding framework for research. Nursing interventions aligned with the theory are influenced by the presence of pain and anxiety. The nursing interventions negatively influence the consequences of needle fear.

Figure 3. Graphic model for concept of needle fear.

Antecedents

Past

experiences

Culture

Environment

Intrinsic-coping, emotions, perceptions

Extrinsic-physical healthcare setting

Care

Provider

Prescribed

Needle

Treatments

Consequences

Negative health

& Avoidance of Care/ Noncompliance

Biopsychosocial Situation

Outcomes

Nursing Interventions

Gate

Control

Theory

Informs

Attributes

Pain Anxiety

Needle Fear

Nursing Interventions

Summary

The phenomenon of interest was identified as needle fear in the context of adult patients receiving cosmetic injections. Using an extensive review of literature, concepts were defined, and conceptual relationships were analyzed. The Gate Control Theory was discussed and applied as a theoretical foundation for future research. A hypothesis was proposed related to the specified population with alignment to the selected theory. Based upon the research and the concept development, a graphic model representing conceptual relationships was proposed. Further research is needed to fully explore the concepts and existing research within the selected theory.

References

ASAPS. (2019). Procedural Statistics. Retrieved from

https://www.surgery.org/sites/default/files/ASAPS-Stats2018_0.pdf

Asok, A., Kandel, E. R., & Rayman, J. B. (2019). The neurobiology of fear and generalization.

Frontiers in Behavioral Neuroscience, 12(329), 1-15.

Aydin, D. & Sahiner, N. C. (2017). Effects of music therapy and distraction cards on pain relief

during phlebotomy in children. Applied Nursing Research, 33, 164-168.

Carter, A. E., AlShwaimi, E., Boschen, M., Carter, G., & George, R., (2019). Influence of

culture change on the perception of fear and anxiety pathways in endodontics:

A pilot proof of concept study. Australian Endodontic Journal, 45, 20-25.

Celek, N. & Khorshid, L. (2015). The use of ShotBlocker for reducing the pain and anxiety

associated with intramuscular injection: randomized, placebo-controlled study. Holistic Nursing Practice, September/October, 261-271. doi: 10.1097/HNP.0000000000000105

Cronin, P., Ryan, F., & Coughlan, M. (2010). Concept analysis in healthcare research.

International Journal of Therapy & Rehabilitation, 17(2), 62–68.

Dunsmoor, J. E., & Murphy, G. L. (2015). Categories, concepts, and conditioning: How humans

generalize fear. Trends in Cognitive Sciences, 19, (2), 73-77.

Gilchrist, P. T., McGovern, G. E., Bekkouche, N., Bacon, S. L., & Ditto, B. (2015). The

vasovagal response during confrontation with blood-injury-injection stimuli: The

role of perceived control. Journal of Anxiety Disorders, 31, 43-48.

Glogan, E., van Vliet, C., Roelandt, R., & Muelders, A. (2019). Generalization and extinction of concept-based pain-related fear. The Journal of Pain, 20(3), 325−338.

Gray, J. R., Grove, S. K., & Sutherland, S. (2017). Burns and Grove’s the practice of

nursing research: Appraisal, synthesis, and generation of evidence (8th ed.).

St Louis, MO: Saunders Elsevier.

Karaman, T., Karaman, S., Dogru, S., Tapar, H., Sahin, A., Suren, M., & Kaya, S. A. Z. (2016).

Evaluating the efficacy of lavender aromatherapy on peripheral venous cannulation

pain and anxiety: A prospective, randomized study. Complementary Therapies in

Clinical Practice, 23, 64-68.

Katz, J., & Rosenbloom, B. N. (2015). Commentary: The golden anniversary of Melzack and

Wall’s gate control theory of pain: Celebrating 50 years of pain research and manage-

ment. Pain Research and Management, 20(6), 285-286. doi: 10.1155/2015/865487

Khanra, S., Asokan, R., & Lenka, A. (2018). Helfer Skin Tap technique on pain associated with

intramuscular injection among adult patients. International Journal of Nursing Education, 10(3), 12-17. doi: 10.5958/0974-9357.2018.000582

Kowalsky, J. M., Conatser, R., Ritz, T., & France, C. R. (2018). Effects of respiratory and

applied muscle tensing interventions on responses to a simulated blood draw among

individuals with high needle fear. Journal of Behavioral Medicine, 41, 771-783.

Kruger, D. F., LaRue, S., & Estepa, P. (2015). Recognition of and steps to mitigate anxiety

and fear of pain in injectable diabetes treatment. Diabetes, Metabolic Syndrome, and

Obesity: Targets and Therapy, 8, 49-56.

Kuwahara, H., & Ogawa, R. (2016). Using a vibration device to ease pain during facial needling

and injection. Open Access Journal of Plastic Surgery, 16, 65-72.

Laureate Education (Producer). (2014). Concepts [Video file]. Baltimore, MD: Author.

Laureate Education (Producer). (2014). Theoretical foundation for research [Video file].

Baltimore, MD: Author.

Laureate Education (Producer). (2014c). Phenomena of interest [Video file]. Baltimore, MD:

Author.

McEwen, M., & Wills, E. M. (2019). Theoretical basis for nursing. (5th ed.). Philadelphia,

PA: Wolters Kluwer Health.

McLenon, J. and Rogers, M. (2019). The fear of needles: A systematic review and meta-

Analysis. Journal of Advanced Nursing, 75, 30-42. doi:10.1111/jan.13818

McMurty, C. M., Taddio, A., Noel, M., Antony, M. M., Chambers, C. T., Asmundosn, G. J. G.,

Riddell, R. P., Shah, V., MacDonald, N. E., Rogers, J., Bucci, L. M., Mousmanis, P.,

Lang, E., Halperin, S., Bowles, S., Halpert, C., Ipp, M., Reider, M. J., Robson, K.,

Uleryk, E., Bleeker, E. V., Dubey, V., Hanrahan, A., Lockett, D., & Scott, J. (2016).

Exposure-based interventions for the management of individuals with high levels of

needle fear across the lifespan: A clinical practice guideline and call for future research.

Cognitive Behavior Therapy, 45(3), 217-235. doi: 10.1018/16506073.2016.1157204

McMurtry, C. M., Riddell, R. P., Taddio, A., Racine, N., Asmundson, G. J. G., Noel, M.,

Chambers, C. T., & Shah, V. (2015). Far from “just a poke”: Common painful needle

procedures and the development of needle fear. Clinical Journal of Pain, 31(10S), S3

S11.

Merriam-Webster, Incorporated. (2019). Avoidance. Retrieved from https://www.merriam-webster.com/dictionary/avoidance

Merriam-Webster, Incorporated. (2019). Anxiety. Retrieved from https://www.merriam-webster.com/dictionary/anxiety

Merriam-Webster, Incorporated. (2019). Fear (noun). Retrieved from https://www.merriamwebster.com/dictionary/fear#other-words

Merriam-Webster, Incorporated. (2019). Needle. Retrieved from https://www.merriam-webster.com/dictionary/needle?src=search-dict-box

Merriam-Webster, Incorporated. (2019). Pain. Retrieved from https://www.merriam-webster.com/dictionary/pain

Redfern, R. E., Micham, J., Seegert, S., & Chen, J.T. (2019). Influencing vaccinations: A Buzzy approach to ease the discomfort of a needle stick-a prospective, randomized control trial. Pain Management Nursing, 20, 164-169. doi: 10.106/j.pmn.2018.07.001

Sahin, M. & Eser, I. (2018). Effect of the Buzzy application on pain and injection satisfaction in adult patients receiving intramuscular injections. Pain Management Nursing, 19(6), 646- 651. doi: 10.1016/j.pmn.2018.07.009

Sahiner, N. J. Inal, S., & Akbay, S. (2015). The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety levels in children. Journal of PeriAnesthesia Nursing, 30(3), 228-235. doi: 10.1016/j.jopan.2014.05.011

Starkstein, S. (2016). Fear: a conceptual analysis and philosophical therapy (Doctoral dissertation). Retrieved from https://researchrepository.murdoch.edu.au/id/eprint/35094/1/Starkstein2016.pdf

Trost, A., Jones, A., Guck, T., Vervoort, J. M., & Kowalsky, C. R. (2017). Initial validation

of a virtual blood draw exposure paradigm for fear of blood and needles. Journal

of Anxiety Disorders, 51, 65-71.

Vijayan, R., Scott, G., Brownlie, W., Male, P., & Chin, K. (2015). How sharp is a “sharp

scratch”?: A mixed methods study of verbal warnings issued before venipuncture.

Pain Practice, 15(2), 132-139.

Walker, L. O., & Avant, K. C. (2019). Strategies for theory construction in nursing (6th ed.).

Upper Saddle River, NJ: Prentice Hall.

Weiss, R. A., & Lavin, P. T. (2009). Reduction of pain and anxiety prior to botulinum toxin

Injections with a new topical anesthetic method. Ophthalmic Plastic Reconstructive

Surgery, 25(3), 173-177.

Wikipedia. (2019). Patrick David Wall. Retrieved from

https://en.wikipedia.org/wiki/Patrick_David_Wall

Wikipedia. (2019). Ronald Melzack. Retrieved from

https://en.wikipedia.org/wiki/Ronald_Melzack

World Health Organization. (2019). Injection practices: Rapid assessment and response guide.

Retrieved from https://www.who.int/infection-prevention/tools/injections/rarg.pdf

Yayla, E. M. & Ozdemir, L. (2019). Effect of inhalation aromatherapy on procedural pain and

anxiety after needle insertion into an implantable central venous port catheter. Cancer Nursing, 42(1), 35-41. doi: 10.1097/NCC.0000000000000551