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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •• 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
研究组 & 干预措施
Intervention Group
Participants in this group will receive training on the 4-7-8 breathing technique and will actively practice this controlled breathing cycle throughout the diagnostic Electromyography (EMG) procedure.
干预措施: 4-7-8 Breathing Technique (Behavioral)
Control Group
Participants in this group will undergo the standard routine diagnostic Electromyography (EMG) procedure without any breathing technique intervention.
结局指标
主要结局
Pain Score
时间窗: Pain levels will be assessed at multiple specific time points throughout the study: baseline (immediately before the EMG procedure), during the EMG procedure,and immediately following the completion of the EMG procedure
Numeric Rating Scale (NRS) will be used to assess the subjective pain levels experienced by patients during the Electromyography (EMG) procedure. The scale ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.
次要结局
- State Anxiety Inventory(Anxiety levels will be assessed at two distinct time points: baseline (immediately before the EMG procedure, prior to random assignment and breathing training) and immediately following the completion of the EMG procedure)
研究者
Nurgül Gün
LECTURER
Hasan Kalyoncu University
