Investigation of the Effects of Relaxation Exercises Applied to Patients With Type 2 Diabetes on Neuropathic Pain, Fatigue and Sleep Quality
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ataturk University
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- S-LANSS Neuropathic Pain Scale
Study Overview
Brief Summary
Relaxation exercises are an important factor in improving diabetes management and quality of life. Diet, exercise, medication and insulin therapy are important components of diabetes management. Among the goals that relaxation exercises should achieve is not only to provide information but also to ensure the patient's active participation in treatment by improving their application skills. Progressive Relaxation Exercises (PGE) are among the effective improvement techniques in the care process. Type 2 diabetes is a common metabolic disease and its chronic complications include neuropathic pain, fatigue and sleep disorders. Nurses play an important role in the care of these patients and the management of such symptoms is at the center of nursing practice. As a result, examining the effects of relaxation exercises on neuropathic pain, fatigue and sleep quality for patients with type 2 diabetes can increase the effectiveness of non-pharmacological approaches in nursing care and improve the quality of life of patients. Such studies have the potential to increase the quality of care and patient satisfaction by supporting the evidence-based practices of nurses. Hypotheses of the Study Hypothesis (H0): Progressive relaxation exercise has no effect on neuropathic pain, fatigue, and sleep quality of individuals with Type 2 diabetes.
Hypothesis (H1): Progressive relaxation exercise has an effect on the neuropathic pain level of individuals with Type 2 diabetes.
Hypothesis (H2): Progressive relaxation exercise has an effect on the fatigue level of individuals with Type 2 diabetes.
Hypothesis (H3): Progressive relaxation exercise has an effect on the sleep quality of individuals with Type 2 diabetes. In light of all this information, the proposed study aimed to investigate the effects of relaxation exercises applied to study groups formed with diabetic patients on neuropathic pain, sleep quality and fatigue.
Detailed Description
Research Phases Preliminary Preparation
A comprehensive literature review was conducted to examine the content and structure of previously published studies. Based on this review, the most suitable materials for the purpose of the present study were identified. Among these, the Progressive Relaxation Exercise Audio CD prepared by the Turkish Psychological Association was selected, and the necessary permissions were obtained for its inclusion in the research. Prior to data collection, official approval was obtained from both the hospital administration and the responsible physician of the Endocrinology Inpatient Unit at Erzurum Atatürk Training and Research Hospital.
Progressive Muscle Relaxation
Progressive Muscle Relaxation (PMR) is a self-administered relaxation technique that involves the sequential tensing and releasing of sixteen major muscle groups in the body. During the exercise, deep breathing accompanies the commands to contract and relax each muscle group - muscles are tensed while inhaling and relaxed while exhaling. This method has been recognized as an effective intervention for reducing pain, anxiety, and depression. Additionally, incorporating mindful awareness of breathing has been shown to accelerate the relaxation response.
The steps of the Progressive Muscle Relaxation exercise are as follows:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •for the Study
- •Those diagnosed with Type II DM for at least six months,
- •Those aged between 18 and 65,
- •Those who are literate,
- •Those taking insulin and oral antidiabetic treatment,
- •Those without a psychiatric illness,
- •Those without any communication problems (vision, hearing, or speech),
- •Those not using sleeping pills,
- •Those with a Pittsburgh Sleep Quality Index average score of 5 or higher,
- •Those with an S-LANSS average score of 12 or higher,
- •Those with a FACIT (Fatigue Scale) average score of less than
Exclusion Criteria
- •for the Study
- •Those with a diabetic foot wound,
- •Those with an amputation,
- •Those with a malignant disease,
- •Those with COPD or asthma,
- •Those who discontinued the Progressive Relaxation Exercise program
Arms & Interventions
intervention group
Progressive relaxation exercises will be applied to the experimental group.
Intervention: progressive relaxation exercise (Diagnostic Test)
no intervention group
The control group will not receive any intervention.
Outcomes
Primary Outcomes
S-LANSS Neuropathic Pain Scale
Time Frame: 6 weeks
The S-LANSS pain score is based on the patient's assessment of the worst pain they have felt in the past week. This scale consists of a total of 7 questions; the first 5 questions are about pain symptoms, while the last 2 questions are aimed at determining the presence of allodynia (pain in response to a stimulus that is normally painless) and decreased pain sensation. The questions are answered only with "yes" or "no". Patients can receive a score between 0 and 24 on the test. The test results of patients who score 12 or higher support neuropathic pain, while the results of patients who score below 12 indicate non-neuropathic pain. (Bennett et al., 2005; Weingarten et al., 2007) The validity and reliability study of the S-LANSS Neuropathic Pain Scale was conducted in 2008 by Dr. Emine Rabia KOÇ. The reliability coefficients (Cronbach alpha value) between the items in the 1st and 2nd applications of the S-LANSS pain score were calculated as 0.74. The correlation coefficients for each
FACIT- (Fatigue) Scale
Time Frame: 6 weeks
The total score range of the scale is between 0 and 52. A high total score indicates that the patient's fatigue is low, while a low total score indicates that the patient's fatigue is high. Items 1, 2, 3, 4, 5, 6, 9, 10, 11, 12, and 13 of the scale are reverse scored, while items 7 and 8 are subject to a direct scoring system. The Cronbach's alpha coefficient of the scale was found to be 0.98. In the item analysis results of the scale, all correlations between the items were significantly high. Exploratory factor analysis methods were used to determine the construct validity of the scale, and the factor loading values of all items were found to be between 0.61 and 0.81. According to the factor analysis results, unlike the original scale, two sub-dimensions were found in the Turkish version of the scale. A general score total of less than 30 indicates severe fatigue.
Pittsburg Sleep Quality (PSQI) Scale
Time Frame: 6 weeks
This scale consists of a total of 24 questions; 19 of these include the individual's own sleep experience, while 5 are answered by the spouse or roommate. Question 19 of the scale does not affect the results. The PSQI includes seven different components that evaluate subjective sleep quality, sleep onset time, sleep duration, sleep efficiency, sleep problems, use of sleeping pills, and daily functioning level. Each component is scored between 0 and 3, and the total score of the scale varies between 0 and 21. (MY, 1996; Roth \& Drake, 2004) If the total score of the PSQI is 5 or higher, it reflects poor sleep quality. The Cronbach's Alpha internal consistency coefficient was found to be 0.80. The diagnostic sensitivity of this scale was determined as 89.6% and the specificity as 86.5%.
Secondary Outcomes
No secondary outcomes reported
Investigators
Eren KILIC
lecturer
Ataturk University