NCT06960408Enrolling by invitation
Effects of Sleep Hygiene Education and Progressive Relaxation Exercise on Anxiety, Sleep Quality and Glycemic Control in Diabetic Patients
Effects of Sleep Hygiene Education and Progressive Relaxation Exercise on Anxiety, Sleep Quality and Glycemic Control in Type 2 Diabetic Patients: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
In diabetic patients, effective glycemic control is important in preventing complications, mortality and morbidity. The main purpose of DM treatment is to prevent neuropathic and vascular complications and to increase quality of life by keeping blood glucose levels and insulin activity within normal limits. It is stated that achieving the targeted glycemic control in diabetic patients reduces the risk of developing vascular complications in patients. In these patients, helping them reach the targeted glycemic level with lifestyle changes or medications is important in preventing the effects of diabetes on individual and community health. In effective DM monitoring and treatment, medical nutrition therapy (MNT), physical activity, drug therapy (OAD and insulin), DM education, patient self-monitoring and ensuring compliance with treatment are important. Although there have been significant developments in the field of treatment and follow-up today, there may be difficulties in achieving the targeted treatment goals in diabetic patients. This situation has led to the investigation of modifiable and non-modifiable factors affecting glycemic control in diabetic patients. Especially in Type 2 Diabetes, if these modifiable factors are diagnosed and managed early, effective management and control of diabetes can be achieved to a great extent. Especially psychological health and sleep health have become one of the new and mandatory modifiable risk factors for glycemic control in DM patients. Although it is known that diabetes is basically a disorder of the endocrine system, it has also been revealed that there is a relationship between psychosocial health and diabetes. Especially the presence of anxiety can cause an increase in blood glucose in diabetic patients, further worsening the patient's condition.Because emotional tension affects both neuroendocrine and hormonal pathways and indirectly the treatment and monitoring of diabetes, leading to blood sugar disorders. It is known that epinephrine secretion is stimulated by anxiety, which reduces the effect of insulin. Even in the simplest psychosocial stress and spiritual conflict, free fatty acids, cortisol and blood sugar increase. Therefore, stress and anxiety are considered important factors in patients whose blood sugar cannot be regulated despite medical treatment. In such cases, psychosocial evaluation should be made before increasing the insulin dose. In addition, studies in the literature show that in addition to the effect of anxiety on glycemic control, poor glycemic control also has an effect on the emergence of anxiety and a positive mutual relationship has been found between anxiety and glycemic control. Therefore, it was emphasized that anxiety and depression levels should be determined in order to consider diabetic patients as a whole. Sleep is a biological requirement and a physiologically active process. It repairs the body by giving strength to the mind and memory. Sleep quality is defined as the efficiency of sleep. Within the scope of sleep quality; sleep efficiency, number of sleep interruptions, total sleep duration, wakefulness duration, sleep transition time and spontaneous awakenings. Sleep, in addition to productivity and efficiency, positively affects cognitive functions such as memory and concentration, and contributes to physical and psychological renewal. Due to such positive effects, sleep is seen as an important variable affecting the individual's quality of life and well-being. Therefore, disruptions that may occur in sleep quality and sleep patterns cause problems such as inability to concentrate, anxiety, depression, increased sensitivity to pain, irritability, hallucinations, loss of appetite and difficulty in excretion, and directly affect the individual's daily life and general health. Therefore, it is important to take sleep health into consideration in order to ensure glycemic control in DM patients. PURPOSE: This study will be conducted to examine the Effect of Sleep Hygiene Education and Progressive Relaxation Exercise on Sleep Quality, Anxiety and Glycemic Control in Type 2 Diabetic Patients.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 7 Apr 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 15 Apr 2026
- Lead sponsor
- Gazi University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06960408
What you commit to
- Study type: Interventional
- Planned participants: 52
- From 1 Jul 2025 to the primary completion date, 15 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol, sleeping pills, Sedative drugs, etc. that may affect sleep. those who use
- Those who are receiving pharmacological/non-pharmacological treatment due to a sleep disorder diagnosis
- Those who are receiving other complementary and alternative treatments during the application process
Other illness
- Those with sleep disorders
- Those with a vision, speech or hearing related disease that may prevent the understanding of the information given and the application of PGE
- Those with a chronic disease that may affect the quality of sleep (such as cancer, COPD, asthma), Those with a neuro-psychiatric disorder (such as dementia, psychotic disorder, bipolar disorder)
- Those whose condition is unstable and who develop a serious complication (such as retinopathy, nephropathy, neuropathy, etc.)
Lab values
- Those with HbA1c values \>7
Other
- Those who work night shifts
- Those who are pregnant
- Those with a disability that will prevent them from doing Progressive Relaxation Exercise
- Those who have any health problems during the application process
- Those who cannot continue the study for any reason, who want to withdraw from the study of their own free will and whose compliance with the progressive relaxation exercise and sleep hygiene training rules is less than 3 days
- Those whose diet and treatment changes during the study.
Who the study is looking for
- 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
- Having a mobile phone belonging to the person to be able to apply PGE
- Being able to use WhatsApp
- Those with a smartphone
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gazi University Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.