Diabetes Mellitus, Type 2NCT06960408
Effects of Sleep Hygiene Education and Progressive Relaxation Exercise on Anxiety, Sleep Quality and Glycemic Control in Diabetic Patients
A study testing sleep hygiene education and progressive relaxation exercise in people with Diabetes Mellitus, Type 2, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- sleep hygiene education and progressive relaxation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
Today, it is known that sleep disorders are quite common in DM patients. In addition, it has been demonstrated that there is a two-way relationship between DM and sleep. The American Diabetes Association (ADA) included sleep as a behavior to be monitored among adults living with DM in its 2022 care standards .The American Academy of Sleep Medicine has also reported a relationship between sleep deprivation and sleep disorders and the progression or seriousness of DM, and stated that DM alone has an effect on sleep quality. Studies in the literature have also shown that sleep quality problems negatively affect diabetes, and a positive relationship has been found between poor sleep quality and hemoglobin A1c (HbA1c). The reason for this is; physiopathologically, in the NREM deep phase of sleep, sympathetic nerve activity decreases and the level of anti-insulin growth hormone increases, and in the second half of sleep, especially in the REM phase of sleep, the level of plasma cortisol, one of the anti-insulin regulatory hormones, increases.
In individuals with poor sleep quality and sleep disorders, the physiological state begins to deteriorate and glucose utilization decreases as a result of increased sympathetic activity, decreased growth hormone, and increased catecholamine and cortisol levels, and hyperglycemia and insulin resistance develop due to glycogenolysis and gluconeogenesis.Another reason is that short and poor sleep duration alters the ability of leptin, which has appetite suppressant properties, and ghrelin, which has appetite stimulant properties, to accurately report the body's calorie needs. This can lead to excessive calorie intake and obesity.Changes in the release of all these hormones that provide energy balance can lead to the risk of developing diabetes and deterioration in glycemic control and micro and macrovascular complications in people with diabetes. In the literature has been shown that insufficient sleep duration and decrease in sleep quality is associated with impaired glucose tolerance and insulin resistance. IAmong the reasons for this effect of sleep in these studies, it is stated that when sleep duration is insufficient and its quality is low, the risk of developing obesity, hyperglycemia and insulin resistance increases due to changes in the secretion of hormones that affect energy intake and expenditure. Therefore, it is important to consider sleep health in order to ensure glycemic control in DM patients. Nurses, who are in constant communication with patients, have important roles in determining the factors affecting the sleep quality of individuals and their sleep needs, diagnosing sleep disorders, and providing treatment. It is seen that the item "Sleep and rest", which is one of the physiological needs, is included in the nursing theory developed by Henderson, one of the important theorists. It is seen that the diagnosis of sleep pattern disturbance is also among the nursing diagnoses determined by NANDA. Therefore, sleep has an important role in nursing care. In addition, there are nursing interventions to improve sleep quality in DM patients. These interventions include sleep hygiene education, cognitive behavioral therapy, health education, music therapy, massage, aromatherapy. Among these interventions, in sleep hygiene education; not going to bed without feeling sleepy, not spending too much time in bed other than sleeping, not forcing yourself to fall asleep, setting sleep routines before going to bed, not taking daytime naps or sleeping, if taking daytime naps, not consuming carbonated drinks or caffeinated products at least 3-4 hours before going to bed, not going to bed hungry, avoiding heavy meals, stressful activities and strenuous movements before going to bed. Some studies were found that sleep hygiene training increased the quality of sleep in Type 2 DM patients. Relaxation exercises, which are effective in activating the parasympathetic system in DM patients, can also be used along with approaches such as sleep hygiene. Progressive relaxation exercise (PRE), one of these exercises, is a method that provides relaxation throughout the body by regularly and voluntarily relaxing large muscle groups in the human body. PRE is an intervention that nurses can teach. Relaxation exercises, one of the effective methods on anxiety and sleep; It is a widely used, effective and inexpensive method to change the behavior and mental processes of the individual. Recently, PGE has also started to be used in diabetes management. In an study conducted on diabetic patients, examining the effect of PGE on blood sugar, it was observed that there was a significant difference in the blood sugar levels of the experimental and control groups. The reason for this situation is thought to be due to the minimization of stress by controlling negative emotions with PGE . In another study examined the relationship between PGE and HbA1c in their randomized controlled study with Type 2 DM patients. According to the results of the study, positive improvements were observed in the HbA1c level of the experimental group, while there was no difference in the control group. It is thought that the reason for this situation is that hormonal activities become stable as PGE reduces stress Although the effects of PGE on sleep quality and glycemic control have been addressed separately in the literature, there is no study showing the effects on sleep quality and glycemic control at the same time. Therefore, it is thought that this study will emphasize the importance of using non-pharmacological interventions in the management of decreased sleep quality and anxiety affecting glycemic control in diabetic patients and will raise awareness about health professionals who apply these non-pharmacological interventions. In addition, it is thought that it will contribute to the literature because it is an evidence-based initiative in the field of nursing.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- sleep hygiene education and progressive relaxation exercise
- Keywords
- sleep, type 2 diabetes mellitus, Progressive muscle relaxation, Sleep quality, glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep hygiene education and progressive relaxation exerciseOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
The HbA1c levels of the participants
The glycemic control of the patients will be evaluated with HbA1c, which is checked every 3 months. Therefore, 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Jul 2025
- Primary completion15 Apr 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Görgülü Polat, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960408
- Sponsor's protocol ID
- 2285360200
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research will be used for scientific purposes and your individual identity information will remain confidential and will not be shared with anyone.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06960408
- Acronym / sponsor ID
- 2285360200
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- sleep, type 2 diabetes mellitus, Progressive muscle relaxation, Sleep quality, glycemic control
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Today, it is known that sleep disorders are quite common in DM patients. In addition, it has been demonstrated that there is a two-way relationship between DM and sleep. The American Diabetes Association (ADA) included sleep as a behavior to be monitored among adults living with DM in its 2022 care standards .The American Academy of Sleep Medicine has also reported a relationship between sleep deprivation and sleep disorders and the progression or seriousness of DM, and stated that DM alone has an effect on sleep quality. Studies in the literature have also shown that sleep quality problems negatively affect diabetes, and a positive relationship has been found between poor sleep quality and hemoglobin A1c (HbA1c). The reason for this is; physiopathologically, in the NREM deep phase of sleep, sympathetic nerve activity decreases and the level of anti-insulin growth hormone increases, and in the second half of sleep, especially in the REM phase of sleep, the level of plasma cortisol, one of the anti-insulin regulatory hormones, increases.
In individuals with poor sleep quality and sleep disorders, the physiological state begins to deteriorate and glucose utilization decreases as a result of increased sympathetic activity, decreased growth hormone, and increased catecholamine and cortisol levels, and hyperglycemia and insulin resistance develop due to glycogenolysis and gluconeogenesis.Another reason is that short and poor sleep duration alters the ability of leptin, which has appetite suppressant properties, and ghrelin, which has appetite stimulant properties, to accurately report the body's calorie needs. This can lead to excessive calorie intake and obesity.Changes in the release of all these hormones that provide energy balance can lead to the risk of developing diabetes and deterioration in glycemic control and micro and macrovascular complications in people with diabetes. In the literature has been shown that insufficient sleep duration and decrease in sleep quality is associated with impaired glucose tolerance and insulin resistance. IAmong the reasons for this effect of sleep in these studies, it is stated that when sleep duration is insufficient and its quality is low, the risk of developing obesity, hyperglycemia and insulin resistance increases due to changes in the secretion of hormones that affect energy intake and expenditure. Therefore, it is important to consider sleep health in order to ensure glycemic control in DM patients. Nurses, who are in constant communication with patients, have important roles in determining the factors affecting the sleep quality of individuals and their sleep needs, diagnosing sleep disorders, and providing treatment. It is seen that the item "Sleep and rest", which is one of the physiological needs, is included in the nursing theory developed by Henderson, one of the important theorists. It is seen that the diagnosis of sleep pattern disturbance is also among the nursing diagnoses determined by NANDA. Therefore, sleep has an important role in nursing care. In addition, there are nursing interventions to improve sleep quality in DM patients. These interventions include sleep hygiene education, cognitive behavioral therapy, health education, music therapy, massage, aromatherapy. Among these interventions, in sleep hygiene education; not going to bed without feeling sleepy, not spending too much time in bed other than sleeping, not forcing yourself to fall asleep, setting sleep routines before going to bed, not taking daytime naps or sleeping, if taking daytime naps, not consuming carbonated drinks or caffeinated products at least 3-4 hours before going to bed, not going to bed hungry, avoiding heavy meals, stressful activities and strenuous movements before going to bed. Some studies were found that sleep hygiene training increased the quality of sleep in Type 2 DM patients. Relaxation exercises, which are effective in activating the parasympathetic system in DM patients, can also be used along with approaches such as sleep hygiene. Progressive relaxation exercise (PRE), one of these exercises, is a method that provides relaxation throughout the body by regularly and voluntarily relaxing large muscle groups in the human body. PRE is an intervention that nurses can teach. Relaxation exercises, one of the effective methods on anxiety and sleep; It is a widely used, effective and inexpensive method to change the behavior and mental processes of the individual. Recently, PGE has also started to be used in diabetes management. In an study conducted on diabetic patients, examining the effect of PGE on blood sugar, it was observed that there was a significant difference in the blood sugar levels of the experimental and control groups. The reason for this situation is thought to be due to the minimization of stress by controlling negative emotions with PGE . In another study examined the relationship between PGE and HbA1c in their randomized controlled study with Type 2 DM patients. According to the results of the study, positive improvements were observed in the HbA1c level of the experimental group, while there was no difference in the control group. It is thought that the reason for this situation is that hormonal activities become stable as PGE reduces stress Although the effects of PGE on sleep quality and glycemic control have been addressed separately in the literature, there is no study showing the effects on sleep quality and glycemic control at the same time. Therefore, it is thought that this study will emphasize the importance of using non-pharmacological interventions in the management of decreased sleep quality and anxiety affecting glycemic control in diabetic patients and will raise awareness about health professionals who apply these non-pharmacological interventions. In addition, it is thought that it will contribute to the literature because it is an evidence-based initiative in the field of nursing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: intervention group | Experimental | Other: sleep hygiene education and progressive relaxation exerciseThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep hygiene education and progressive relaxation exerciseThe 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 | Experimental: intervention group |
Primary outcome
Pittsburg Sleep Quality Index (PSQI)
Time frame: 6 months
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.
Beck Anxiety Inventory (BAI)
Time frame: 6 months
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.
Progressive Relaxation Exercise and Sleep Hygiene Training Compliance Chart
Time frame: 6 months
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.
1 secondary outcome
The HbA1c levels of the participants
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Results publication1. 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
- Individual participant dataSharing planned: No. The research will be used for scientific purposes and your individual identity information will remain confidential and will not be shared with anyone.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep hygiene education and progressive relaxation exercise in people with Diabetes Mellitus, Type 2, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburg Sleep Quality Index (PSQI) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06960408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.