CClinicalTrials.gg
CompletedNCT05956743Updated Sep 18, 2023

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

An interventional study of progressive relaxation exercise sessions and Sham in Diabetes Mellitus, Type 2, sponsored by Mersin University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-09-18.

Sponsored by Mersin University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

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. Worldwide, 537 million adults live with diabetes, and Type 2 Diabetes is the most common type of diabetes worldwide, accounting for approximately 90% of all diabetes cases. According to the Diabetes Epidemiological Study in Turkey data (TURDEP-I and II), the prevalence of diabetes increased from 7.2% to 13.7%. While there is a globally agreed target to halt the increase in diabetes by 2025, both the number of cases and the prevalence of diabetes continue to rise steadily over the past few decades. It is estimated that the total number of individuals with diabetes will increase to 643 million by 2030 and to 784 million by 2045. 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. diabetes association recently included sleep as a behavior to watch among adults living with diabetes in its 2019 and 2020 standards of care. Sleep; It is a periodic process in which physical activities are at the lowest level and the level of consciousness shows reversible changes. Sleep quality, which is one of the most important aspects of sleep; It is a complex phenomenon that is difficult to define and measure objectively. Sleep quality; It includes quantitative aspects of sleep such as sleep latency, duration of sleep, and the number of awakenings per night, and more subjective aspects such as sleep depth and restfulness. Sleep; It includes a multidimensional regeneration process, including physiological, psychological and social. For this reason, it is affected by positive/negative changes in the dimensions it covers. The slightest disruption to sleep patterns has definite and direct effects on daily life and general health. Therefore; stay healthy; Sleep is necessary to renew and repair systems such as neurological 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 chronic diseases such as diabetes reduce sleep quality and regularity; It is known to cause sleep disorders. Individuals with uncontrolled diabetes often wake up sweating at night or due to nocturia. Controlling blood sugar with dietary changes, exercise, and medications can reduce sleep problems. Night movements or pain caused by the presence of neuropathy in the patient may also negatively affect sleep quality.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. Sleep deprivation is a risk factor for impaired glucose tolerance, patients with diabetes have low sleep quality, there is a significant relationship between diabetes and sleep quality, and people with Type 2 Diabetes have poor sleep quality. Studies have determined that the probability of developing impaired fasting blood glucose in individuals is 6 times higher than in individuals who sleep an average of 6-8 hours at night and have good sleep quality. According to the report of the "American Academy of Sleep Medicine" center, the development or worsening of diabetes with sleep deprivation and sleep disorder there is a link between them. There are metabolic syndrome components such as hyperinsulinemia, central obesity, glucose intolerance in "Obstructive Sleep Apnea" which is a kind of sleep disorder. It is stated in the publications that "Obstructive Sleep Apnea" causes the development of diabetes by disrupting the glucose metabolism. Obstructive sleep apnea, short sleep duration, shift work, and insomnia are all associated with a higher risk of type 2 diabetes and may have worse outcomes for those with existing diabetes. Complementary and integrated applications such as progressive relaxation exercise, which is one of the cognitive behavioral techniques, have been frequently used in research 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.

Progressive relaxation is a method that provides relaxation throughout the body by regular voluntary and successive contraction and relaxation of large muscle groups in the human body. Purpose of progressive relaxation exercises; It is based on feeling the difference between tension and looseness in the body and learning to relax in our daily life. This method, which is applied in the form of stretching and relaxing the muscles, allows the patients to learn where their muscles are, what they are in the moment of tension, and the difference when the tension disappears. Benefits of progressive muscle relaxation in diabetes; It improves metabolic control, lowers blood sugar, lowers catecholamines and autonomic nerve activity. After relaxation, the patient will feel relaxed and relaxed, progressive relaxation body; will be able to make the mind calm and relaxed. Relaxation improves blood circulation, increases the secretion of endorphins and decreases the secretion of adrenal hormones, reduces stress and anxiety after the emergence of a positive attitude due to increased brain function, and facilitates sleep. Progressive relaxation exercises are a skill that can be taught by nurses and learned in both inpatient and outpatient settings that include the nurse's role as educator, caregiver, role model and patient advocate, and is included in the Classification of Nursing Interventions (NIC). Nurses' use of high-level nursing practices, such as training patients with relaxation exercises, improves the patient's self-management skills and provides symptom control. 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • sleep quality
  • exercise
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 70 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Mersin University is the lead sponsor of 173 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 18 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    intervention group

    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 comparator
    Sham group

    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

  • Otherprogressive relaxation exercise sessions

    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.

  • OtherSham

    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.

06

What researchers measure

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.

    Time frame: Four week

07

Study locations

1 site
  • Nigde Training and Research Hospital
    Niğde, Merkez/ Ni̇ğde 51100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05956743
Lead sponsor
Mersin University
Responsible party
Ecem BİRER (NURSE, Mersin University) — Principal investigator
First posted
Jul 21, 2023
Start date
Jun 1, 2023
Primary completion
Jul 14, 2023
Completion
Sep 1, 2023
Last update
Sep 18, 2023

Study contacts

Diğdem LAFCI, Assoc. Dr.
principal investigator · Mersin University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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