Clinical trial NCT06794918: Investigation of the Effects of Relaxation Exercises on Neuropathic Pain, Fatigue and Sleep Quality
Official title: Investigation of the Effects of Relaxation Exercises Applied to Patients With Type 2 Diabetes on Neuropathic Pain, Fatigue and Sleep Quality
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Progressive Relaxation Exercise
Neuropathic Pain
Fatigue
Sleep Quality
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: S-LANSS Neuropathic Pain Scale
timeFrame: 6 weeks
measure: FACIT- (Fatigue) Scale
timeFrame: 6 weeks
measure: Pittsburg Sleep Quality (PSQI) Scale
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Türkiye
country: Turkey
facility: University, Ataturk University Campus, 25030 Yakutiye
state: Erzurum
Study officials:
affiliation: Ataturk University
name: eren k Kılıç
role: PRINCIPAL_INVESTIGATOR
References: