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Diabetes Mellitus, Type 2NCT05956743

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

A study testing progressive relaxation exercise sessions in people with Diabetes Mellitus, Type 2, run by Mersin University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
progressive relaxation exercise sessions
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2023to 1 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Nigde Training and Research Hospital

    Niğde, Merkez/ Ni̇ğde, 51100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Progressive Relaxation Exercise on Sleep Quality in Patients With Type 2 Diabetes

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.

Being tested
progressive relaxation exercise sessions, Sham
Keywords
sleep quality, exercise
Medical subject headings
Diabetes Mellitus, Type 2, Sleep Initiation and Maintenance Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • progressive relaxation exercise sessionsOther

    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.
    3. 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.
  • ShamOther

    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.
    2. 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.
Study groups in NCT05956743
Study groupRoleWhat they receive
intervention groupActive comparatorIntervention 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.
Receives: Other: progressive relaxation exercise sessions
Sham groupSham comparator1 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.
Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Four week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2023
  2. Study start1 Jun 2023
  3. Primary completion14 Jul 2023
  4. Study completion1 Sep 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The research is carried out in two groups as control and intervention groups.
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05956743
Sponsor's protocol ID
MersinU-SBF-EB-01
Status last verified
Sep 2023
First submitted
14 Jul 2023
Last updated
18 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing progressive relaxation exercise sessions in people with Diabetes Mellitus, Type 2, run by Mersin 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 18 Sep 2023. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pittsburgh Sleep Quality Index (time frame: Four week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Sep 2023.

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