Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy

The Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography Procedure in Individuals With Type 2 Diabetes Who Have Diabetic Neuropathy: A Randomized Controlled Study

This study aims to determine the effect of the 4-7-8 breathing technique, applied during Electromyography (EMG) for the diagnosis of diabetic peripheral neuropathy, on the pain and anxiety levels experienced by patients with Type 2 diabetes.

EMG is a diagnostic method that can cause pain and anxiety in patients. Due to the limited number of non-pharmacological studies in the literature focusing on pain management in diabetic individuals during this process, the investigation of the effectiveness of the 4-7-8 breathing technique, which strengthens parasympathetic activity, using a randomized controlled design constitutes the unique value of this study.

The research will be conducted in a randomized controlled experimental design. The sample will consist of individuals diagnosed with Type 2 diabetes who are referred to the EMG outpatient clinic of Osmaniye Training and Research Hospital. The experimental group will receive training on the 4-7-8 breathing technique and will be instructed to apply it during the procedure, while the control group will receive the routine clinical protocol. Data will be collected using the Patient Identification Form, Numerical Rating Scale (NRS), State Anxiety Scale (SAS), and Neuropathic Pain Questionnaire (DN4). The study expects the 4-7-8 breathing technique to significantly reduce pain and anxiety levels. It aims to improve the comfort of diabetic patients during procedures and the quality of diagnostic data, and to introduce this method into the literature as a low-cost and independent pain management strategy in nursing care. Furthermore, the study aligns with the "Health and Quality of Life" (SDG3) goal, which is part of the Sustainable Development Goals set by the United Nations. SDG3 offers a comprehensive global framework aimed at ensuring healthy living for all individuals and promoting well-being at all ages; it includes increasing access to health services, improving the quality of care, and strengthening patient-centered approaches.

Diabetes is a progressive, chronic disorder characterized by β-cell damage in the pancreas and insulin resistance, leading to persistently elevated blood glucose levels. Genetic predisposition, along with factors such as insufficient physical activity and unhealthy diet, play a role in the development of diabetes. Type 2 diabetes is the most common type among all diabetes cases. This deterioration, if not effectively managed, leads to significant complications. Diabetic neuropathy is one of the most common complications of diabetes and is a neurodegenerative disorder of the peripheral nervous system. It presents with pain starting distally in the lower extremities, and controlled glycemic control plays a crucial role in its progression. Methods used in the definition of diabetic peripheral neuropathy include: Monofilament testing includes the assessment of needle prick sensation, temperature perception, ankle reflexes, and evaluation perception, as well as nerve conduction studies and electromyography (EMG).

Electromyography (EMG) is a clinical diagnostic method that evaluates the physical details of the muscular and nervous systems, and most patients may experience a certain level of pain and psychological discomfort, including anxiety and worry. According to the literature, the pain experienced by patients undergoing EMG varies depending on their age and education level. In addition, although the music played during EMG does not significantly reduce pain, it has been observed that the average pain relief, the lifespan of the device during the procedure, and the cost of the procedure are not negatively affected. A study found that written information study before the procedure and stress during electrodiagnostic tests reduced pain and anxiety. The International Association for the Study of Pain defines pain as an unpleasant sensory and emotional experience resulting from actual or potential tissue damage. Pain can be classified according to time, the region of origin, and parameters. Acute pain is a type of pain that begins suddenly with tissue damage, usually lasts less than three to six months, and decreases with the healing process, but can lead to anxiety, restlessness, and changes in vital functions in individuals. Non-pharmacological pain management methods can be divided into two main categories: peripheral techniques (massage, hot-cold application, TENS, acupuncture, menthol application, vibration, and therapeutic touch) and behavioral therapeutic methods (breathing exercises, relaxation, distraction, music). These methods are effective in both reducing pain perception and alleviating stress effects. These interruptions increase pain intensity and improve patient comfort through gate control theory, endorphin release, and distraction. One such strategy, the 4 7 8 breathing technique, involves interrupting the breath, optimizing tissue oxygenation by increasing oxygen uptake, and this mechanism contributes to prolonged muscle tension and reduced pain temperature. 478 breaths are performed as a four-second deep inhalation through the nose, a seven-second breath-hold, and an eight-second controlled exhalation through the mouth; this structure can relax vagal tone, add parasympathetic activity, and increase pain tolerance. Additionally, randomized controlled trials have shown that 478 breaths have positive outcomes in terms of psychological stress and functional impairment. Furthermore, non-pharmacological 478 breaths not only reduce patients' pain but also empower caregivers to manage their pain independently, enabling them to manage patient education and care practices; this holistic approach is enhanced for both the patient and caregiver.

H01: The 4-7-8 breathing technique applied during EMG procedures in individuals with type 2 diabetes and diabetic neuropathy has no effect on pain levels.

H11: The 4-7-8 breathing technique applied during EMG procedures in individuals with type 2 diabetes and diabetic neuropathy has an effect on pain levels.

H02: The 4-7-8 breathing technique applied during EMG procedures in individuals with type 2 diabetes and diabetic neuropathy has no effect on anxiety levels.

H22: The 4-7-8 breathing technique applied during EMG procedures in individuals with type 2 diabetes and diabetic neuropathy has an effect on anxiety levels.Research Design This study aims to determine the effect of the 4-7-8 breathing technique applied during EMG procedures on pain and anxiety levels in individuals with Type 2 Diabetes and diabetic neuropathy. The study is a randomized controlled experimental design.

Research Population and Sample

The research population consists of patients with Type 2 diabetes and diabetic neuropathy who are referred to the EMG clinic by the Internal Medicine, Endocrinology and Metabolism Diseases, and Neurology outpatient clinics of Osmaniye Training and Research Hospital for scheduled EMG procedures. Since there is no similar study article in the literature on patients undergoing EMG, a pilot study will be conducted to determine the sample size. Within the scope of the pilot study, it is planned to carry out the randomization process with 12 participants. In this stage, the block randomization method was preferred in assigning the participants to the experimental and control groups in a 1:1 ratio. Randomization was performed using a computer-based program (Randomizer.org). These combinations are; The blocks were determined as ABAB (1), BAAB (2), BBAA (3), and AABB (4). As part of the preliminary application, numbers from 1 to 4 were randomly ordered in a computer environment (Randomizer.org), and each number was coded to represent the relevant block combination. The resulting combination was determined as BAAB, BAAB, and AABB. In the first stage of the research, after the inclusion of 12 patients in the study, the data obtained will be used to perform a post-hoc power analysis with 95% confidence, 80% power, and 0.5 effect size via the G*Power 3.1 program. Based on the effect size, significance level, and power values obtained from the analysis, the sample size of the study will be recalculated, and if deemed necessary, the sample size will be increased and the research will continue. Inclusion Criteria:

• Between 18-70 years of age,
• Diagnosed with Type 2 DM for at least 1 year,
• Patients with diabetic peripheral neuropathy and DN4 score >3,
• Individuals who are cooperative and can communicate in Turkish. • Individuals without orthopedic or neurological disabilities that would prevent the tests

Exclusion Criteria:

• Individuals with severe autonomic neuropathy findings (resting tachycardia, etc.),
• Individuals with respiratory system diseases that prevent deep breathing, such as COPD and asthma,
• Individuals with active infection or compromised skin integrity (dryness, cracks, open wounds, lesions, etc.) in the area where EMG will be performed,
• Individuals with masses (tumors, cystic formations, etc.) in the anatomical area where EMG will be performed,
• Individuals with varicose veins (signs of venous insufficiency) in the anatomical area where EMG will be performed,
• Individuals with edema in the area where EMG will be performed that may affect the quality of electrophysiological recordings,
• Individuals with dialysis catheters, central venous catheters, or implanted venous ports,
• Use of analgesics (painkillers) within 24 hours prior to the procedure,
• Individuals who cannot follow breath commands due to hearing or visual impairment.
• Individuals with any muscle disease,
• Individuals receiving chemotherapy/radiotherapy treatment at any time,
• Individuals who have undergone knee, hip, or lumbar surgery,
• Pregnant women,
• Individuals with any inflammatory rheumatic disease,
• Patients with pacemakers or ICDs,
• Individuals with chronic kidney failure Data Collection Tools Patient Introduction Form: This form was created by researchers in line with the literature. It was prepared to determine the sociodemographic characteristics (age, gender, education, marital status), disease course, and treatment characteristics of individuals with type 2 diabetes. In addition, a general profile of their clinical condition is created by evaluating the presence of chronic diseases and laboratory findings (HbA1c, glucose) of the participants. Numeric Rating Scale (NRS): This is a widely used measurement tool to assess the pain intensity of individuals. The scale consists of a 10 cm line that can be applied horizontally or vertically, with "0" (no pain) at one end and "10" (unbearable pain) at the other.

State Anxiety Inventory (SAI): The scale was developed. Its validity and reliability in Turkey were established by Öner and Le Compte. It consists of two parts: the State Anxiety Scale and the Trait Anxiety Scale. In this study, the "State Anxiety Scale" (SAS), which consists of the first 20 items, was used to assess situational anxiety. The scale yields a minimum score of 20 and a maximum score of 80. Higher scores indicate higher anxiety levels. In the reliability study of the Turkish adaptation, the Cronbach's alpha coefficient was found to be 0.96

Neuropathic Pain Questionnaire (DN4): It consists of a total of four questions, 10 items. Neuropathic pain is defined as such if a score of 4 or higher is obtained on a 10-point scale. Neuropathic pain is assessed based on the 7 items in the first two questions of the scale, which are directly based on patient interviews, and the 3 items in the last two questions, which are based on the patient's clinical examination.

Visual Analog Scale (VAS): This is a simple and sensitive measurement tool used to assess satisfaction levels. Satisfaction levels are evaluated on a linear scale where the lower and upper limits represent "not satisfied at all" and "highest satisfaction," respectively. Participants are asked to indicate the point that best represents their satisfaction with the medical care they received. The obtained values are scored on a scale of 0-10, with higher scores indicating increased satisfaction levels.

Application Protocol In the first phase of the research, it is planned to conduct the randomization process with 12 participants as part of the preliminary application. At this stage, block randomization was preferred for assigning participants to the experimental and control groups in a 1:1 ratio. Randomization was performed using a computer-based program (Randomizer.org).

In order to ensure balance between groups within the scope of block randomization, four different block combinations were defined beforehand. These combinations were determined as ABAB (1), BAAB (2), BBAA (3), and AABB (4). As part of the preliminary application, numbers from 1 to 4 were randomly ordered in a computer environment (Randomizer.org), and each number was coded to represent the relevant block combination. According to the resulting random number sequence, the block order was determined as BAAB (2), BAAB (2), and AABB (4). According to this block order, it is planned to assign participants to the experimental (A) and control (B) groups in accordance with the order in which they were included in the study. After the sample size is finalized based on the data obtained from the preliminary application, the same randomization method will be continued in the main study process for assigning participants to groups, and a new randomization list of appropriate size for the study sample will be created while maintaining the predefined block combinations. The randomization sequence will be created independently of the researcher involved in the application process and will be conducted in a way that minimizes predictability in the assignment process.The study will be conducted by a researcher working in the EMG outpatient clinic and holding a master's degree in nursing. All participants will undergo a standardized clinical protocol during the EMG procedure, and all individuals will use the same type and specifications of disposable surface electrodes. Stimulation intensity will be adjusted considering each individual's physiological characteristics (skin impedance, subcutaneous fat tissue thickness, and individual tolerance level) to ensure optimal recording quality. These adjustments will be standardized for all participants within the framework of predefined standard clinical limits and protocols. Intervention Group (4-7-8 Breathing Technique) At the acceptance stage for the EMG procedure, patients will be taught the 4-7-8 breathing technique via video demonstration on a tablet by a trained researcher.

1. Preparation: The patient is placed in a supine position, ensuring that the shoulder and leg muscles are relaxed.

2. Procedure:

   • The patient is asked to breathe in quietly through the nose (inflating the diaphragm) for 4 seconds,
   • Hold their breath for 7 seconds,
   • Exhale slowly through the mouth with a controlled, gentle whistling sound ("hiss") for 8 seconds.

   Patients are shown the technique practically, and after it is confirmed that they can perform it correctly, they are asked to continue this breathing cycle throughout the EMG procedure.

3. During EMG: During the EMG procedure, patients are asked to perform the 4-7-8 breathing technique throughout the placement of the surface electrodes and the recording process. This includes inhaling through the nose for 4 seconds, holding their breath for 7 seconds, and then slowly exhaling through the mouth over 8 seconds. Patients are guided to maintain this breathing cycle regularly throughout the procedure. The researcher provides verbal guidance to the patient to support the continuity of the breathing exercise. The intervention continues until the EMG recording is complete. Control Group Patients receive standard clinical information about the procedure. No specific breathing instructions will be given; only routine relaxation commands ("Release yourself") will be provided.

In this study, individuals with type 2 diabetes and diabetic neuropathy who are scheduled for EMG will first be evaluated for eligibility. Individuals who do not meet the inclusion criteria, refuse to participate in the study, or are otherwise unsuitable will be excluded.

All participants who meet the inclusion criteria will be invited to the study and will be included after obtaining their informed consent. Participants will initially be administered a Patient Identification Form, an anxiety scale, a pain assessment scale, and the DN4 Neuropathic Pain Scale. Participants will then be randomly assigned to two groups. Group I (Intervention Group): Participants in this group will receive standard clinical information before the EMG procedure, as well as training in the 4-7-8 breathing technique. Group II (Control Group): Participants in this group will only receive standard clinical information. During the EMG Procedure: Participants in the intervention group will practice the 4-7-8 breathing technique, and their pain levels will be assessed during the procedure. Participants in the control group will be offered routine relaxation techniques and their pain levels will be assessed. After the EMG Procedure: Anxiety levels, pain levels, DN4 neuropathic pain scores, and satisfaction levels of participants in both groups will be re-evaluated. Data Evaluation Research data will be analyzed using SPSS 24.0 software. Descriptive statistics will be presented as number, percentage, mean, and standard deviation. The normality of the data will be evaluated using the Shapiro-Wilk test. Independent samples t-test and ANOVA will be used for normally distributed data, and Kruskal-Wallis tests will be used for non-normally distributed data. Categorical variables will be analyzed using the Chi-square test. The statistical significance level will be accepted as p<0.05. Limitations of the Study Due to the fact that the study was conducted in a single city, the findings obtained may not be generalizable to all patients. The fact that some of the data are based on patients' self-reports (pain, anxiety level) may cause bias in the measurements. In addition, the nature of the intervention group makes it difficult for participants to know which group they belong to in order to prevent blinding. Since the effect of the intervention will be evaluated in the short term in this study, information about long-term effects may not be available. Ethical Principles Before the research begins, ethical approval will be obtained from the Osmaniye Korkut Ata University Health Sciences Research Ethics Committee. After ethical approval, the necessary permissions will be obtained from the institution where the study will be conducted. The purpose, process, benefits, and possible risks of the research will be explained to the individuals participating in the study, and their verbal and written informed consent will be obtained. The research will be conducted in accordance with the principles of the Helsinki Declaration.

Inclusion Criteria:

• Individuals aged 18-70 years who:

  • Have been diagnosed with Type 2 DM for at least one year,
  • Have diabetic peripheral neuropathy and are taking medications with a DN4 score >3,
  • Are cooperative and can communicate in Turkish. • Do not have orthopedic or surgical contraindications that would prevent them from undergoing testing.

Exclusion Criteria:

• • Individuals with severe autonomic neuropathy findings (resting tachycardia, etc.),

  • Individuals with respiratory system diseases that prevent deep breathing, such as COPD and asthma,
  • Individuals with active infection or compromised skin integrity (dryness, cracks, open wounds, lesions, etc.) in the area where EMG will be performed,
  • Individuals with a mass (tumor, cystic formation, etc.) in the anatomical area where EMG will be performed,
  • Individuals with varicose veins (signs of venous insufficiency) in the anatomical area where EMG will be performed,
  • Individuals with edema in the area where EMG will be performed that may affect the quality of electrophysiological recordings,
  • Individuals with a dialysis catheter, central venous catheter, or implanted venous port,
  • Individuals who have used analgesics (painkillers) within 24 hours prior to the procedure,
  • Individuals who cannot follow breath commands due to hearing or visual impairment. • Individuals with any muscle disease,
  • Individuals receiving chemotherapy/radiotherapy treatment at any time,
  • Individuals who have undergone knee, hip, or lumbar surgery,
  • Pregnant women,
  • Individuals with any inflammatory rheumatic disease,
  • Patients with pacemakers or ICDs,
  • Individuals with chronic kidney failure