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

NCT06794918 | Active Not Recruiting

• 1 other identifier: ErenKILIC
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• S-LANSS Neuropathic Pain Scale

  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

  6 weeks

• FACIT- (Fatigue) Scale

  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.

  6 weeks

• Pittsburg Sleep Quality (PSQI) Scale

  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%.

  6 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

Progressive relaxation exercises will be applied to the experimental group.

Diagnostic Test: progressive relaxation exercise

no intervention group

NO INTERVENTION

The control group will not receive any intervention.

Interventions

progressive relaxation exercise DIAGNOSTIC_TEST

Researchers will teach individuals pge exercises to help them relax

intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

University, Ataturk University Campus, 25030 Yakutiye

Erzurum, Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Neuralgia; Fatigue; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• eren k Kılıç

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: January 20, 2025
• Primary Completion: March 20, 2025
• Study Completion: February 7, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

TU (1)