Investigation of the Effects of Relaxation Exercises on Neuropathic Pain, Fatigue and Sleep Quality

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes; Sleep Quality; Progressive Relaxation Exercise; Neuropathic Pain; Fatigue

• Registration Number: NCT06794918
• Lead Sponsor: Ataturk University

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.

This research was planned as a randomized controlled experimental study. The research will be conducted with Type 2 DM patients who apply to Erzurum Ataturk Education and Research Hospital Endocrinology Polyclinic/Inpatient Service. The universe of the research will consist of patients who apply to Erzurum Ataturk Education and Research Hospital Endocrinology Polyclinic/Inpatient Service and are followed up and diagnosed with Type 2 DM. The sample size of the research was calculated using the G\*Power 3.1. 9.6 program. In the calculation, the 2-group (Experimental Group, Control Group) and 2-measurement (Pretest, Posttest) research design was taken into consideration and the sample calculation was made for the independent groups t-test. In the calculation, medium effect size (d = 0.50), 5% margin of error (α = 0.05) and 80% power (1-β = 0.80) were taken into account, and the sample number for each group was calculated as 30. Considering the possibility of data loss, the sample size for each group was increased by 10% and it was planned to include 35 people in each group, a total of 70 people in the sample. In collecting the research data; the Patient Identification Form prepared by the researcher with literature including the socio-demographic and disease-related characteristics of the patients and the patient's metabolic values, the S-LANSS Neuropathic Pain Scale to assess the neuropathic pain levels of diabetic individuals, the FACIT-Fatigue Scale to assess the fatigue levels of diabetic individuals and the Pittsburgh Sleep Quality Index (PUKI) Scale to assess the sleep quality of diabetic patients will be used. The research data will be analyzed using the SPSS 26.0 (Statistical Package for the Social Sciences) program. Frequency, percentage, mean and standard deviation values will be calculated in the evaluation of descriptive data. The significance level will be accepted as 0.05 (p \< 0.05) in the analyses. The Shapiro Wilks test will be used for normal distribution. The mean scores of the scales used to evaluate neuropathic pain, fatigue, and sleep quality of the experimental and control groups will be compared between the groups using a t-test in independent groups, and the comparison of the mean pre-test and post-test scores within the group will be evaluated using a t-test in dependent groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-20
• Status Verified: 2025-01
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-24
• Last Update Submitted: 2025-01-24
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-06-15
• Study Completion: 2026-02-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients who have been diagnosed with TYPE II DM for at least six months,

• Are between the ages of 18-65,
• Are literate,
• Are receiving insulin + oral antidiabetic treatment,
• Do not have a psychiatric disease,
• Do not have a communication problem (vision, hearing and speech),
• Do not use sleeping pills,
• Have a Pittsburgh Sleep Quality Index score average of 5 and above,
• Have a S-LANSS score average of 12 and above,
• Have a FACİT (Fatigue Scale) score average of less than 30 points,
• Individuals who agree to participate in the study will be included.

Exclusion Criteria

Diabetic Foot wounds,

• Amputation,
• Receiving chemotherapy or radiotherapy treatment,
• Oncological disease,
• COPD or asthma,
• Those who stopped Progressive Relaxation Exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
S-LANSS Neuropathic Pain Scale	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	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	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%.

Trial Locations

Locations (1)

University, Ataturk University Campus, 25030 Yakutiye; 🇹🇷 Türkiye, Erzurum, Turkey