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Sleep Hygiene and Relaxation Exercises for Anxiety and Sleep Quality in Type 2 Diabetes

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What is being tested

sleep hygiene education and progressive relaxation exercise

Other
Who is being recruted

Mental Disorders+9

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

From 18 to 64 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: May 2025
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Summary

Principal SponsorGazi University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 15, 2025

Actual date on which the first participant was enrolled.

This study is exploring how teaching good sleep habits and using relaxation exercises can help people with Type 2 Diabetes manage their anxiety, improve sleep quality, and control their blood sugar levels. Sleep problems are common in people with diabetes and can make managing the condition even harder. Poor sleep can lead to increased blood sugar levels and difficulties with insulin. The study aims to show how non-drug approaches, like sleep hygiene education and progressive relaxation exercises, can be beneficial in managing these issues, potentially leading to better overall health and less reliance on medications. Participants in the study will receive education on how to improve their sleep, such as setting sleep routines, avoiding caffeine before bed, and engaging in calming activities. They will also practice progressive relaxation exercises, which involve tensing and then relaxing different muscle groups to reduce stress. The study will measure changes in anxiety levels, sleep quality, and blood sugar control to see if these methods are effective. By participating, individuals may experience improved sleep and reduced anxiety, potentially leading to better management of their diabetes. The study highlights the importance of these non-drug methods and their potential benefits for people with diabetes.

Official TitleEffects of Sleep Hygiene Education and Progressive Relaxation Exercise on Anxiety, Sleep Quality and Glycemic Control in Type 2 Diabetic Patients: A Randomized Controlled Trial
NCT06960408
Principal SponsorGazi University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

52 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesSleep Initiation and Maintenance DisordersMetabolic DiseasesNervous System DiseasesNutritional and Metabolic DiseasesSleep Wake DisordersSleep Disorders, IntrinsicDyssomniasGlucose Metabolism Disorders

Criteria

7 inclusion criteria required to participate
Being between 18-65 years of age

Literate

Having a PSQI score >5

Having been diagnosed with Type 2 diabetes for at least one year

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14 exclusion criteria prevent from participating
Alcohol, sleeping pills, Sedative drugs, etc. that may affect sleep. those who use

Those with HbA1c values >7

Those who work night shifts

Those with sleep disorders

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The study will be conducted with diabetic individuals who come to the endocrine clinic. The study will be conducted for 6 months. Intervention group Individuals who accept the study will be given face-to-face Progressive Relaxation Exercise training by the researcher in the first week of the first month of the study and will be applied. The Progressive Relaxation Exercise application will also be sent to the patient via WhatsApp and will be applied with the researcher via online interviews in the 2nd, 3rd and 4th weeks for 30 minutes 3 days a week (Monday-Wednesday-Friday). From the 2nd month of the study to the end of the 6th month, the patient will be asked to do the Progressive Relaxation Exercise on their own for 30 minutes 3 days a week (Monday, Wednesday, Friday). No intervention will be made to the control group.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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