Effects of Sleep Hygiene Education and Progressive Relaxation Exercise on Anxiety, Sleep Quality and Glycemic Control in Diabetic Patients

NCT06960408 | Enrolling By Invitation DMC

• 1 other identifier: 2285360200
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

sleep; type 2 diabetes mellitus; Progressive muscle relaxation; Sleep quality; glycemic control

Outcome Measures

Primary Outcomes (3)

• Pittsburg Sleep Quality Index (PSQI)

  Data will be collected regarding the sleep quality scale be made at the beginning (week 0), immediately after the intervention 2 months (week 8) and 3 months (week 12) and at the end of the 6th month.The Pittsburgh Sleep Quality Index was developed by Buysse et al. (1989) in 1989. The validity and reliability of this scale in our country was determined by Ağargün et al. (1996) in 1996. The Cronbach Alpha internal consistency coefficient of the scale is 0.80. The coefficient being between 0.60-0.80 indicates that the reliability level is good. The PSQI consists of a total of 24 questions that evaluate the sleep quality in the last month. 19 of them are self-report questions. PSQI evaluate sleep quality in the last month. High component score averages indicate that sleep disturbances related to that component have increased. The total score has a value between 0-21.A PSQI global score of more than 5 is an indication of poor sleep quality.

  6 months

• Beck Anxiety Inventory (BAI)

  Data will be collected regarding the BAI be made at the beginning (week 0), immediately after the intervention 2 months (week 8) and 3 months (week 12) and at the end of the 6th month. is a self-assessment scale developed by Beck and colleagues (1988) and used to determine the frequency of anxiety symptoms experienced by individuals. Its Turkish validity and reliability studies were conducted by Ulusoy and colleagues (1993). It is a Likert-type scale with a total of 21 self-assessment sentences, scored between 0 and 3. A high total score indicates a high level of anxiety or its severity. According to the scores obtained from the BAI, the anxiety levels of patients are; 0-17 points indicate low, 18-24 points indicate moderate, and 25 and above indicate a high level of anxiety.

  6 months

• Progressive Relaxation Exercise and Sleep Hygiene Training Compliance Chart

  This chart was created with 3 options to determine how often individuals apply progressive relaxation exercise and sleep hygiene rules. In the literature, it has been determined that the frequency of PGE application varies between 4-12 weeks. Since individuals will be asked to do PGE exercise 3 days a week in this study, those who do it less than 3 days will be excluded from the study.

  6 months

Secondary Outcomes (1)

• The HbA1c levels of the participants

  the HbA1c levels of the participants will be measured at the 0th and 12th weeks of the study and at the end of the 6th month and recorded on the follow-up form

Study Arms (2)

Experimental: intervention group

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.

Other: sleep hygiene education and progressive relaxation exercise

No intervention

NO INTERVENTION

No intervention will be made to the control group. Only data collection tools will be filled. Data collection tools (Individual identification form, PUKI, BAI) will be filled in face to face at the beginning (0th week), 8th and 12th weeks and at the end of the 6th month. The glycemic control of the patients will be evaluated with HbA1c checked every 3 months. Therefore, the HbA1c levels of the participants will be measured in the 0th and 12th weeks of the study and recorded on the follow-up form.

Interventions

sleep hygiene education and progressive relaxation exercise OTHER

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.

Experimental: intervention group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Those who are pregnant
• Those who are receiving pharmacological/non-pharmacological treatment due to a sleep disorder diagnosis
• 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.)
• 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 are receiving other complementary and alternative treatments 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• 1. Hood, M. M., Reutrakul, S., Crowley, S. J. (2014). Night Eating İn Patients With Type 2 Diabetes. Associations with Glycemic Control, Eating Patterns, Sleep, and Mood. Appetite,79, 91- 96. 2. Sakamoto R,. Yamakawa, T., Takahashi,K. Suzuki,J., Shinoda, M.M., Sakamaki,K. Association of usual sleep quality and glycemic control in type 2 diabetes in Japanese: A cross sectional study. Sleep and Food Registry in Kanagawa (SOREKA). PLoS One2018 Jan 24;13(1):e0191771. 3. Akca, D. ve Saritas, S. (2021). Tip 2 diyabetli hastalarda gözlenen semptomlar ile uyku kalitesi arasındaki ilişki. Annals of Medical Research , 26 (4), 0579-0583. https://annalsmedres.org/index.php/aomr/article/view/1243. 4. Avianti, N., Desmaniarti, Z., & Rumahorbo, H. (2016). Progressive muscle relaxation effectiveness of the blood sugar patients with type 2 diabetes. Open Journal of Nursing, 6(3), 248-254. 5. Lou, P., Qin, Y., Zhang, P., Chen, P., Zhang, L., Chang, G., Li, T., Qiao, C., Zhang, N. (2015). Association Of Sleep Quality and Quality Of Life İn Type 2 Diabetes Mellitus: A Cross-Sectional Study İn China. Diabetes research and clinical practice, 107(1), 69-76. 6. Biggers, A., Barton, I., Henkins, J., Kim, H., Perez, R., Ong, J.,Sharp,L.K., Gerber, B.S. (2023). Association Between Sleep Hygiene Practices Scale And Sleep Quality İn Black and Latinx Patients With Uncontrolled Type 2 Diabetes.Sleep Med X, 2;5:100066. 7. Jamini,T. (2024).Theeffect of sleep hygiene on sleep quality of people with type 2 diabetes mellitus. Jurnal EduHealth, 15(01), 61-68. Retrieved from https://ejournal.seaninstitute.or.id/index.php/healt/article/view/3734 8. Amanda,S. P. (2019). Progressive musclerelaxation in improving sleep quality. Journal of Health, 6(2), 90-9 9. Trimurthula, S.R, Perakam, S., Kondapalli, A (2020). The Effect of Jacobson's Progressive Muscle Relaxation Technique along with Structured Exercise Program on HbA1c in Type II Diabetes Mellitus Patients. International Journal of Health S

  RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sleep Initiation and Maintenance Disorders

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 7, 2025
• Study Start: July 1, 2025
• Primary Completion: April 15, 2026
• Study Completion: May 15, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)