Diabetic PatientsNCT06079463
The Effect of Progressive Relaxation Exercise on Anxiety and Quality of Life of Diabetic Patients
A study testing progressive relaxation exercise in people with Diabetic Patients, run by Kahramanmaraş İstiklal University at 1 site in Turkey (Türkiye).
Trial summary
Purpose of the study: The study aimed to direct the anxiety and quality of life of progressive movement exercise in diabetic patients. Type of research: A randomized controlled pre-test-post-test study was planned with the aim of directing progressive movement exercise on anxiety and quality of life in diabetics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Patients
- What is being tested?
- progressive relaxation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2023to 1 Jan 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diabetic patients who will be treated in the Internal Medicine Service who want to participate in the study voluntarily.
- Patients over the age of 18
Who cannot join
- Patients who do not want to participate in the study.
- Patients who are unable to perform the progressive relaxation exercise (amputation, etc.).
- Pregnant or breastfeeding patients
Trial locations and contacts
1 site in 1 country.
Esin Kavuran contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atatürk Üniversitesi
Erzurum, 25030
Esin Kavuran, Phd, 5374302319, esinkavuran@hotmail.com
About this study
Official title: Determining the Effect of Progressive Relaxation Exercise on Anxiety and Quality of Life in Diabetes Patients
Purpose of the study: The study aimed to direct the anxiety and quality of life of progressive movement exercise in diabetic patients.
Type of research: A randomized controlled pre-test-post-test study was planned with the aim of directing progressive movement exercise on anxiety and quality of life in diabetics.
research questions Q1: Does progressive movement exercise have an effect on diabetic anxiety and quality of life? Population of the Research and Sample Selection: The home of the research will be the diabetes windows to the internal service on data collection. G-power 3.1 analysis program environment to calculate large sample size. Sampling of the research; With 0.61% effect sizes, 0.05% error level, 95% confidence interval and 80% power to show the universe, 52 people took part in the experimental motivations (phased training exercises group) and 52 people took part in the control slots, for a total of 104 people. Sample selection criteria patients are randomized using the Random Integer Generator method from the Numbers subheading on the Random.org website. In randomization, aspects will be collected representatively of 1 experimental group and 2 control groups.
Read the detailed description
Diabetes mellitus (DM) is an important health problem all over the world, which mostly starts in middle and advanced ages and has an important place among non-communicable chronic diseases due to its high morbidity and mortality. It can affect the patient biologically, psychologically, socially and psychosexually. In addition, generalized anxiety disorder was observed in 14% of the patients and an increase in anxiety levels was observed in 40%. Meta-analyses have shown that the presence of diabetes in an individual has a 24% risk of developing depression. This increase in depression and anxiety in DM negatively affects the patient's compliance and response to treatment and the prognosis of the disease. In addition, it causes deterioration in self-care and quality of life, the risk of developing complications, morbidity, mortality and health expenditures. Progressive relaxation exercise (PGE) is the voluntary contraction and relaxation of large muscle groups in the body, and noticing the difference. The PGE technique, developed by Jacobson in 1934, is based on the idea that anxiety-provoking thoughts and events create physiological tension. Doctor Edmund Jacobson developed the PGE to raise awareness of skeletal muscle tension. Muscle tension is triggered by various negative emotions and psychosomatic diseases. With this exercise, relaxation is aimed to reduce the feeling of tension and the perceived stress level. Progressive relaxation exercises are an inexpensive method that can be easily taught by nurses, yoga instructors, clinical psychologists, and other complementary alternative medicine practitioners. PGE is performed one-on-one or as a group, in one or several sessions, with the help of a CD or sound recorder. In order to increase its effectiveness, it can be applied with musical accompaniment, visual imagery or diaphragmatic breathing. Deep relaxation can be used to prevent the tensions experienced after stressful events from harming the body; It is one of the physiological and psychological relaxation methods such as sports and sleep. It is very useful for maintaining physical and mental health. It is suggested that a deep relaxation exercise that usually lasts 25-30 minutes can provide a benefit close to the benefit of two hours of deep sleep. In the literature, it is stated that if these exercises can be performed consistently and systematically for a long time, they have positive effects on stress-based insomnia, migraine pain, diabetes and high blood pressure. When we look at the literature, it has been determined that progressive relaxation exercises have a positive effect on anxiety and quality of life in many disease groups, but it has been observed that there are not enough studies in which these exercises are applied in diabetes patients and their effects on anxiety and quality of life are examined. The research is important in that it will examine the effect of progressive relaxation exercises on anxiety and quality of life, which is essential for diabetic patients.
- Conditions
- Diabetic Patients
- Being tested
- progressive relaxation exercise
- Keywords
- Anxiety, Diabetes, Exercise, Quality of Life
- Medical subject headings
- Anxiety Disorders, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive relaxation exerciseOther
Step 1: Take a comfortable position (sitting or lying down) and wear comfortable, non-tightening clothes.
Step 2: Try to relax with eyes closed, without focusing on thoughts, by focusing on your own body muscles.
Step 3: Right and left, respectively, hands, arms (triceps muscle), chest, abdomen, hips, legs (thigh muscles), feet and toes, neck, shoulder (scapula muscles) and muscle groups on the face (around the eyes, chin) and eyebrow muscles) by concentrating on contracting and relaxing these muscles.
Step 4: Focusing on the muscle groups of the whole body, contracting and relaxing.
Step 5: Opening the eyes slowly, trying to feel the feeling of comfort in the body (Turkish Psychologists Association Progressive Relaxation Exercises).
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients undergoing progressive relaxation exercise | Experimental | After the purpose of the study was explained and their verbal and written consents were obtained, a questionnaire including the Beck Anxiety Scale, which includes the socio-demographic characteristics, and the World Health Organization Quality of Life Scale, were applied to the patients in the experimental and control groups. will participate in the research, will be asked, and will be filled in face to face by the responsible researcher. After the progressive relaxation exercise training is given to the experimental group patients, the voice recording containing the commands for the application of the progressive relaxation exercise will be sent to the phone of the patient and/or their relatives. Patients in the experimental group spent an average of 25-30 minutes each day for four weeks. Ongoing exercises will be conducted and followed up. At the end of the fourth week, "Beck Anxiety Scale and World Health Organization Quality of Life Scale" will be applied. Receives: Other: progressive relaxation exercise |
| Diabetic patients not applied progressive relaxation exercise | No intervention | After explaining the purpose of the study and obtaining their verbal and written consents, a questionnaire form including the Beck Anxiety Scale and the World Health Organization Quality of Life Scale, in which the socio-demographic characteristics of the experimental and control group patients who will participate in the research, are asked, will be filled in face to face by the principal researcher.Then, a voice recording containing the commands for the application of the progressive relaxation exercise will be sent to the phone of the volunteer patients in this group and/or their relatives, and they will be informed about how to apply it. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Scale
Progressive relaxation exercise was applied to the patients for 4 weeks. After the application, anxiety scores were determined with the Back Anxiety Scale and the results were recorded.
Measured: 4 weeks
Secondary outcomes (1)
World Health Organization Quality of Life Scale
Progressive relaxation exercise was applied to the patients for 4 weeks. After the application, quality of life scores were determined with the World Health Organization Quality of Life Scale and the results were recorded.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start10 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PatientsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The experimental group consisted of 52 people (the group in which progressive movements exercises were applied) and the control group consisted of 52 people, a total of 104 people. Patients who meet the sample selection criteria are randomized using the Random Integer Generator method from the Random.org organelle Numbers sub-title. In the randomization, the 1-digit experiment will continue to represent the 2-digit control group.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaraş İstiklal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gazi Baran CAMCI, Kahramanmaraş İstiklal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079463
- Sponsor's protocol ID
- KahramanmarasIstiklalU
- Status last verified
- Aug 2024
- First submitted
- 5 Jul 2023
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Progressive Relaxation Exercise on Anxiety and Quality of Life in Diabetes Patients
- ClinicalTrials.gov ID
- NCT06079463
- Acronym / sponsor ID
- KahramanmarasIstiklalU
- Conditions
- Diabetic Patients
- Keywords
- Anxiety, Diabetes, Exercise, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Kahramanmaraş İstiklal UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 12 Oct 2023 (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.
Purpose of the study: The study aimed to direct the anxiety and quality of life of progressive movement exercise in diabetic patients.
Type of research: A randomized controlled pre-test-post-test study was planned with the aim of directing progressive movement exercise on anxiety and quality of life in diabetics.
research questions Q1: Does progressive movement exercise have an effect on diabetic anxiety and quality of life? Population of the Research and Sample Selection: The home of the research will be the diabetes windows to the internal service on data collection. G-power 3.1 analysis program environment to calculate large sample size. Sampling of the research; With 0.61% effect sizes, 0.05% error level, 95% confidence interval and 80% power to show the universe, 52 people took part in the experimental motivations (phased training exercises group) and 52 people took part in the control slots, for a total of 104 people. Sample selection criteria patients are randomized using the Random Integer Generator method from the Numbers subheading on the Random.org website. In randomization, aspects will be collected representatively of 1 experimental group and 2 control groups.
Detailed description
Diabetes mellitus (DM) is an important health problem all over the world, which mostly starts in middle and advanced ages and has an important place among non-communicable chronic diseases due to its high morbidity and mortality. It can affect the patient biologically, psychologically, socially and psychosexually. In addition, generalized anxiety disorder was observed in 14% of the patients and an increase in anxiety levels was observed in 40%. Meta-analyses have shown that the presence of diabetes in an individual has a 24% risk of developing depression. This increase in depression and anxiety in DM negatively affects the patient's compliance and response to treatment and the prognosis of the disease. In addition, it causes deterioration in self-care and quality of life, the risk of developing complications, morbidity, mortality and health expenditures. Progressive relaxation exercise (PGE) is the voluntary contraction and relaxation of large muscle groups in the body, and noticing the difference. The PGE technique, developed by Jacobson in 1934, is based on the idea that anxiety-provoking thoughts and events create physiological tension. Doctor Edmund Jacobson developed the PGE to raise awareness of skeletal muscle tension. Muscle tension is triggered by various negative emotions and psychosomatic diseases. With this exercise, relaxation is aimed to reduce the feeling of tension and the perceived stress level. Progressive relaxation exercises are an inexpensive method that can be easily taught by nurses, yoga instructors, clinical psychologists, and other complementary alternative medicine practitioners. PGE is performed one-on-one or as a group, in one or several sessions, with the help of a CD or sound recorder. In order to increase its effectiveness, it can be applied with musical accompaniment, visual imagery or diaphragmatic breathing. Deep relaxation can be used to prevent the tensions experienced after stressful events from harming the body; It is one of the physiological and psychological relaxation methods such as sports and sleep. It is very useful for maintaining physical and mental health. It is suggested that a deep relaxation exercise that usually lasts 25-30 minutes can provide a benefit close to the benefit of two hours of deep sleep. In the literature, it is stated that if these exercises can be performed consistently and systematically for a long time, they have positive effects on stress-based insomnia, migraine pain, diabetes and high blood pressure. When we look at the literature, it has been determined that progressive relaxation exercises have a positive effect on anxiety and quality of life in many disease groups, but it has been observed that there are not enough studies in which these exercises are applied in diabetes patients and their effects on anxiety and quality of life are examined. The research is important in that it will examine the effect of progressive relaxation exercises on anxiety and quality of life, which is essential for diabetic patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental group consisted of 52 people (the group in which progressive movements exercises were applied) and the control group consisted of 52 people, a total of 104 people. Patients who meet the sample selection criteria are randomized using the Random Integer Generator method from the Random.org organelle Numbers sub-title. In the randomization, the 1-digit experiment will continue to represent the 2-digit control group.
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients undergoing progressive relaxation exercise | Experimental | Other: progressive relaxation exerciseAfter the purpose of the study was explained and their verbal and written consents were obtained, a questionnaire including the Beck Anxiety Scale, which includes the socio-demographic characteristics, and the World Health Organization Quality of Life Scale, were applied to the patients in the experimental and control groups. will participate in the research, will be asked, and will be filled in face to face by the responsible researcher. After the progressive relaxation exercise training is given to the experimental group patients, the voice recording containing the commands for the application of the progressive relaxation exercise will be sent to the phone of the patient and/or their relatives. Patients in the experimental group spent an average of 25-30 minutes each day for four weeks. Ongoing exercises will be conducted and followed up. At the end of the fourth week, "Beck Anxiety Scale and World Health Organization Quality of Life Scale" will be applied. |
| Diabetic patients not applied progressive relaxation exercise | No intervention | –After explaining the purpose of the study and obtaining their verbal and written consents, a questionnaire form including the Beck Anxiety Scale and the World Health Organization Quality of Life Scale, in which the socio-demographic characteristics of the experimental and control group patients who will participate in the research, are asked, will be filled in face to face by the principal researcher.Then, a voice recording containing the commands for the application of the progressive relaxation exercise will be sent to the phone of the volunteer patients in this group and/or their relatives, and they will be informed about how to apply it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetic patients who will be treated in the Internal Medicine Service who want to participate in the study voluntarily.
- Patients over the age of 18
Key exclusion criteria (3 listed)
- Patients who do not want to participate in the study.
- Patients who are unable to perform the progressive relaxation exercise (amputation, etc.).
- Pregnant or breastfeeding patients
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 |
|---|---|---|
| progressive relaxation exerciseStep 1: Take a comfortable position (sitting or lying down) and wear comfortable, non-tightening clothes. Step 2: Try to relax with eyes closed, without focusing on thoughts, by focusing on your own body muscles. Step 3: Right and left, respectively, hands, arms (triceps muscle), chest, abdomen, hips, legs (thigh muscles), feet and toes, neck, shoulder (scapula muscles) and muscle groups on the face (around the eyes, chin) and eyebrow muscles) by concentrating on contracting and relaxing these muscles. Step 4: Focusing on the muscle groups of the whole body, contracting and relaxing. Step 5: Opening the eyes slowly, trying to feel the feeling of comfort in the body (Turkish Psychologists Association Progressive Relaxation Exercises). | Other | Diabetic patients undergoing progressive relaxation exercise |
Primary outcome
Beck Anxiety Scale
Time frame: 4 weeks
Progressive relaxation exercise was applied to the patients for 4 weeks. After the application, anxiety scores were determined with the Back Anxiety Scale and the results were recorded.
1 secondary outcome
World Health Organization Quality of Life Scale
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
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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. This study is not recruiting at the moment.
Esin Kavuran contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive relaxation exercise in people with Diabetic Patients, run by Kahramanmaraş İstiklal 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gazi Baran CAMCİ (5059779139, baran.cmmci@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Scale (time frame: 4 weeks). 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 29 Aug 2024.