CompletedNot Applicable

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

Turkey (Türkiye)88 participantsStarted 2023-09-15

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 30. 3.9. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

S-LANSS Neuropathic Pain Scale

Timeframe: 6 weeks

FACIT- (Fatigue) Scale

Timeframe: 6 weeks

Pittsburg Sleep Quality (PSQI) Scale

Timeframe: 6 weeks

Trial details

NCT IDNCT06794918

SponsorAtaturk University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-20

View on ClinicalTrials.gov More Type 2 Diabetes trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.