Progressive Relaxation Exercise on Sleep Quality in Patients With Type 2 Diabetes

NCT05956743 | Completed

• 1 other identifier: MersinU-SBF-EB-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of progressive relief exercise on sleep quality in patients with type 2 diabetes. Diabetes is among the diseases known as non-communicable or chronic diseases that occur as a result of the pancreas not producing enough insulin or the body's inability to use the insulin it produces and increasing the costs of care all over the world. Counseling and health education are among the key components of diabetes management. Diabetes management consists of drug therapy, self-management, medical nutrition therapy, exercise and education parameters, and sleep disorders are ignored in diabetes management. The slightest disruption to sleep patterns has definite and direct effects on daily life and general health. Therefore; stay healthy; Sleep is necessary renew and repair systems such as to renew and muscle systems. Inadequate sleep quality can lead to impaired cognition, and sleep quality is an important aspect of life. Sleep disturbance or poor sleep quality is higher in individuals with chronic disease. Sleep disturbance in diabetes is associated with higher HbA1c levels and diseases such as diabetes reduce sleep quality and regularity; It is known to cause sleep disorders. Especially in Type 2 Diabetes cases, sleep problems are common. Having a chronic illness like Type 2 Diabetes can have an impact on sleep quality and rate alone. Complementary and integrated applications such as progressive relaxation exercise, which is one of the cognitive behavioral techniques, have been frequently used in researches in the field of nursing, due to its effects such as relatively relieving tension and anxiety in skeletal muscles, facilitating the transition to sleep and helping to reduce sleep problems. Despite the differences in progressive muscle relaxation methods, studies have shown that progressive muscle relaxation has important results in improving sleep quality in individuals with chronic diseases. In this respect, it is predicted that progressive relaxation exercise may give positive results on sleep quality in individuals with diabetes.

Conditions

Diabetes Mellitus, Type 2

Keywords

sleep quality; exercise

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index

  The Pittsburgh Sleep Quality Index (PUKI) was developed(1989). The scale consists of 24 questions in total. 19 of these questions are answered by the individual and 5 of them are answered by the relative/roommate of the individual. Of these 5 questions and self-assessment questions, the last question, Question 19 (regarding the availability of a roommate or spouse), is used for clinical information only and is not included in the scoring. PUKI; The questions answered directly by the individual consist of 7 sub-components in which sleep duration, subjective sleep quality, sleep efficiency, sleep delay, degree of sleep disturbance in daytime work, and use of sleeping pills are evaluated. Each component is evaluated with a score between 0-3 and a total of 0-21 points can be obtained from the scale. An increase in the PUKI score means that the quality of sleep worsens. A total PUKI score of 5 or more is considered poor sleep quality.

  Four week

Study Arms (2)

intervention group

ACTIVE COMPARATOR

Intervention Group: A total of 6 weeks of planning will be made with the working group. 1 week : Patients included in the study group and meeting the research criteria will be informed about the research. Pre-test data forms for each patient who accepted to participate in the study, Patient Identification Form, Pittsburgh Sleep Quality Index (PUKI) within 30 minutes will be collected. 2.,3.,4.,5. week: Patients will practice a total of 12 progressive relaxation exercise sessions for 30 minutes, 3 times a week (Monday, Wednesday, Friday) for 4 weeks, accompanied by the training booklet and music player. 6 week: In the last week of the application, individuals will be called to the hospital and in the Diabetes Polyclinic training room.A final test will be made by the researcher. The Pittsburgh Sleep Quality Index (PUKI) will be reapplied.

Other: progressive relaxation exercise sessions

Sham group

SHAM COMPARATOR

1 week: After informing Sham group patients about the research at the first interview, Patient Information Form, Pittsburgh Sleep Quality Index (PUKI) will be applied. In the 6th week of the study, individuals will be called to the hospital and the post-test Pittsburgh Sleep Quality Index (PUKI) will be re-administered by the researcher in the diabetes polyclinic training room. 6 week: Since the study was terminated after the 6th week, a booklet and music player will be given to the patients. In addition, progressive relaxation exercise training will be given to the patients and the importance of using it in their lives will be explained.

Other: Sham

Interventions

progressive relaxation exercise sessions OTHER

Intervention Group: A total of 6 weeks of planning will be made with the working group. 1. week: Patients included in the study group and meeting the research criteria will be informed about the research. Pre-test data forms for each patient who accepted to participate in the study, Patient Identification Form, Pittsburgh Sleep Quality Index (PUKI) within 30 minutes will be collected. 2. ,3.,4.,5. week: Patients will practice a total of 12 progressive relaxation exercise sessions for 30 minutes, 3 times a week (Monday, Wednesday, Friday) for 4 weeks, accompanied by the training booklet and music player. 6\. week: In the last week of the application, individuals will be called to the hospital and in the Diabetes Polyclinic training room. A final test will be made by the researcher. The Pittsburgh Sleep Quality Index (PUKI) will be reapplied.

intervention group

Sham OTHER

1\. week: After informing Sham group patients about the research at the first interview, Patient Information Form, Pittsburgh Sleep Quality Index (PUKI) will be applied. 6\. week: In the 6th week of the study, individuals will be called to the hospital and the post-test Pittsburgh Sleep Quality Index (PUKI) will be re-administered by the researcher in the diabetes outpatient training room. Since the study was terminated after the 6th week, a booklet and music player will be given to the patients. In addition, progressive relaxation exercise training will be given to the patients and the importance of using it in their lives will be explained.

Sham group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Type 2 Diabetes for at least 6 months
• Not having any disease causing insomnia and not using sleeping pills
• Willing to participate in the research
• years and older
• Fluent in Turkish, Literate
• Understanding the given information and practicing the progressive relaxation exercise
• Related to vision, speech and hearing, which can interfere with the application of without disease,
• Not having a psychiatric diagnosis and not taking any medication for anxiety or depression
• Patients who have a music player or a personal mobile phone at home will be included in order to practice progressive relaxation exercises.

You may not qualify if:

• Those who do not agree to participate in the research
• Having any disease that causes insomnia and using sleeping pills
• Visual, speech and hearing impairments that can prevent the understanding of the given information and the implementation of the progressive relaxation exercise.
• sick
• Having a psychiatric diagnosis and taking medication for anxiety or depression
• Do not have a music player or a personal mobile phone at home in order to practice progressive relaxation exercises.
• Patients working in shifts will not be included.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Nigde Training and Research Hospital

Niğde, Merkez/ Ni̇ğde, 51100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sleep Initiation and Maintenance Disorders; Motor Activity

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior

Study Officials

• Diğdem LAFCI, Assoc. Dr.

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and the researcher cannot be blinded due to the nature of the research. According to the randomized controlled research design, in this study, the groups of patients who would or would not be treated according to the simple random sampling method were determined.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NURSE

Model Details: The research is carried out in two groups as control and intervention groups.

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 21, 2023
• Study Start: June 1, 2023
• Primary Completion: July 14, 2023
• Study Completion: September 1, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)