Type 2 Diabetes MellitusNCT07876401
Effects of Progressive Muscle Relaxation on Anxiety, Depression, and Quality of Life in Adults With Type 2 Diabetes
A study testing Progressive Muscle Relaxation in people with Type 2 Diabetes Mellitus, run by Gul Dural at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study evaluated the effects of an eight-week progressive muscle relaxation program on anxiety, depression, and quality of life in 80 adults with type 2 diabetes mellitus. Participants were randomly assigned to the intervention group (n = 40) or the control group (n = 40). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2024to 15 Apr 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Diagnosed with type 2 diabetes mellitus for at least six months.
- No medical condition preventing participation in progressive muscle relaxation exercises.
- Able to communicate effectively.
- Provided informed consent to participate.
Who cannot join
- Visual, speech, or hearing impairments that hindered communication, understanding of instructions, or use of the progressive muscle relaxation materials.
- Severe diabetes-related complications, such as neuropathy, retinopathy, or nephropathy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Firat University, Faculty of Health Sciences, Department of Nursing
Elâzığ
About this study
Official title: The Effect of Progressive Muscle Relaxation Exercises on Anxiety, Depression, and Quality of Life in Patients With Type 2 Diabetes: A Mixed-Methods Study
This randomized controlled study evaluated the effects of an eight-week progressive muscle relaxation program on anxiety, depression, and quality of life in 80 adults with type 2 diabetes mellitus. Participants were randomly assigned to the intervention group (n = 40) or the control group (n = 40). The intervention included individual training lasting approximately 30-40 minutes, an educational booklet, relaxation audio recordings for home practice, and weekly telephone follow-up. Participants were instructed to practise the exercises every morning for eight weeks. The control group received no study-specific relaxation intervention. Anxiety, depression, and quality of life were assessed at baseline and at week eight. A subsequent qualitative component involved in-depth interviews with 10 participants to explore their experiences with the program.
Read the detailed description
This study used a randomized controlled pretest-posttest design within a sequential explanatory mixed-methods framework. The quantitative component evaluated the effects of an eight-week progressive muscle relaxation (PMR) program on anxiety, depression, and quality of life in adults with type 2 diabetes mellitus. The subsequent qualitative component explored participants' experiences to support interpretation of the quantitative findings.
Participants were recruited from the endocrinology outpatient clinic and inpatient ward of a university hospital. The quantitative component included 80 participants randomly assigned to the PMR group or the control group, with 40 participants in each group.
Before the intervention, sociodemographic and clinical information was collected using a Patient Information Form. Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale, and quality of life was assessed using the Ferrans and Powers Quality of Life Index, Diabetes Version. These outcome measures were administered again in both groups eight weeks after baseline.
Participants in the PMR group received an individual training session lasting approximately 30-40 minutes. A researcher-developed information booklet supported instruction in the exercise technique. Relaxation exercise audio recordings prepared by the Turkish Psychological Association were uploaded to participants' mobile devices to guide home practice. Participants were instructed to perform the exercises every morning for eight weeks. Weekly telephone calls provided follow-up during the intervention period.
Participants in the control group did not receive the study PMR intervention and completed the same baseline and eight-week outcome assessments.
Following the intervention, in-depth interviews were conducted with 10 participants to explore their experiences with the PMR program. A researcher-developed semi-structured interview guide addressed perceived changes in daily life, experiences of benefit, and suggestions for improving the program. Two pilot interviews were used to refine the guide. Qualitative recruitment continued until thematic saturation was reached. Quantitative and qualitative findings were integrated during interpretation.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Progressive Muscle Relaxation
- Keywords
- Progressive muscle relaxation; Type 2 diabetes; anxiety; depression; quality of life; mixed-methods study
- Medical subject headings
- Diabetes Mellitus, Type 2, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle RelaxationBehavioural
Participants received a 30-40-minute individual training session on progressive muscle relaxation, supported by a researcher-developed information booklet. The technique involved sequentially tensing and relaxing muscle groups. Relaxation exercise audio recordings prepared by the Turkish Psychological Association were uploaded to participants' mobile devices to guide home practice. Participants were instructed to practice every morning for eight weeks. Weekly telephone calls provided follow-up throughout the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation Group | Experimental | Participants received individual progressive muscle relaxation training lasting approximately 30-40 minutes, supported by a researcher-developed information booklet. Relaxation exercise audio recordings prepared by the Turkish Psychological Association were uploaded to participants' mobile devices to support home practice. Participants were instructed to perform the exercises every morning for eight weeks and received weekly follow-up telephone calls. Anxiety, depression, and diabetes-related quality of life were assessed at baseline and week 8. Receives: Behavioral: Progressive Muscle Relaxation |
| Control Group | No intervention | Participants did not receive the study progressive muscle relaxation program. Anxiety, depression, and diabetes-related quality of life were assessed at baseline and eight weeks later using the same questionnaires as in the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diabetes-Related Quality of Life Score from Baseline to Week 8
Quality of life was assessed using the Ferrans and Powers Quality of Life Index, Diabetes Version. The instrument assesses satisfaction with different aspects of life and the importance attributed to those aspects. It provides a total score and scores for health and functioning, social and economic, psychological/spiritual, and family domains. Higher scores indicate better quality of life. Assessments were conducted at baseline and week 8.
Measured: Baseline and week 8
Secondary outcomes (2)
1. Anxiety
Anxiety was assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). This subscale contains seven items, each scored from 0 to 3, yielding a total score of 0-21. Higher scores indicate greater anxiety. Scores were assessed at baseline and week 8 to evaluate changes over the intervention period.
Measured: Baseline and week 8
Change in Depression Score from Baseline to Week 8
Depression was assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS). This subscale contains seven items, each scored from 0 to 3, yielding a total score of 0-21. Higher scores indicate greater depressive symptoms. Scores were assessed at baseline and week 8 to evaluate changes over the intervention period.
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start10 Sep 2024
- Primary completion10 Sep 2025
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gul Dural
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gul Dural, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876401
- Sponsor's protocol ID
- 2024/07-46
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation Exercises on Anxiety, Depression, and Quality of Life in Patients With Type 2 Diabetes: A Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT07876401
- Acronym / sponsor ID
- 2024/07-46
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Progressive muscle relaxation; Type 2 diabetes; anxiety; depression; quality of life; mixed-methods study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Gul DuralUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 15 Oct 2026 (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.
This randomized controlled study evaluated the effects of an eight-week progressive muscle relaxation program on anxiety, depression, and quality of life in 80 adults with type 2 diabetes mellitus. Participants were randomly assigned to the intervention group (n = 40) or the control group (n = 40). The intervention included individual training lasting approximately 30-40 minutes, an educational booklet, relaxation audio recordings for home practice, and weekly telephone follow-up. Participants were instructed to practise the exercises every morning for eight weeks. The control group received no study-specific relaxation intervention. Anxiety, depression, and quality of life were assessed at baseline and at week eight. A subsequent qualitative component involved in-depth interviews with 10 participants to explore their experiences with the program.
Detailed description
This study used a randomized controlled pretest-posttest design within a sequential explanatory mixed-methods framework. The quantitative component evaluated the effects of an eight-week progressive muscle relaxation (PMR) program on anxiety, depression, and quality of life in adults with type 2 diabetes mellitus. The subsequent qualitative component explored participants' experiences to support interpretation of the quantitative findings.
Participants were recruited from the endocrinology outpatient clinic and inpatient ward of a university hospital. The quantitative component included 80 participants randomly assigned to the PMR group or the control group, with 40 participants in each group.
Before the intervention, sociodemographic and clinical information was collected using a Patient Information Form. Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale, and quality of life was assessed using the Ferrans and Powers Quality of Life Index, Diabetes Version. These outcome measures were administered again in both groups eight weeks after baseline.
Participants in the PMR group received an individual training session lasting approximately 30-40 minutes. A researcher-developed information booklet supported instruction in the exercise technique. Relaxation exercise audio recordings prepared by the Turkish Psychological Association were uploaded to participants' mobile devices to guide home practice. Participants were instructed to perform the exercises every morning for eight weeks. Weekly telephone calls provided follow-up during the intervention period.
Participants in the control group did not receive the study PMR intervention and completed the same baseline and eight-week outcome assessments.
Following the intervention, in-depth interviews were conducted with 10 participants to explore their experiences with the PMR program. A researcher-developed semi-structured interview guide addressed perceived changes in daily life, experiences of benefit, and suggestions for improving the program. Two pilot interviews were used to refine the guide. Qualitative recruitment continued until thematic saturation was reached. Quantitative and qualitative findings were integrated during interpretation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation Group | Experimental | Behavioral: Progressive Muscle RelaxationParticipants received individual progressive muscle relaxation training lasting approximately 30-40 minutes, supported by a researcher-developed information booklet. Relaxation exercise audio recordings prepared by the Turkish Psychological Association were uploaded to participants' mobile devices to support home practice. Participants were instructed to perform the exercises every morning for eight weeks and received weekly follow-up telephone calls. Anxiety, depression, and diabetes-related quality of life were assessed at baseline and week 8. |
| Control Group | No intervention | –Participants did not receive the study progressive muscle relaxation program. Anxiety, depression, and diabetes-related quality of life were assessed at baseline and eight weeks later using the same questionnaires as in the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older.
- Diagnosed with type 2 diabetes mellitus for at least six months.
- No medical condition preventing participation in progressive muscle relaxation exercises.
- Able to communicate effectively.
- Provided informed consent to participate.
Key exclusion criteria (2 listed)
- Visual, speech, or hearing impairments that hindered communication, understanding of instructions, or use of the progressive muscle relaxation materials.
- Severe diabetes-related complications, such as neuropathy, retinopathy, or nephropathy.
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 Muscle RelaxationParticipants received a 30-40-minute individual training session on progressive muscle relaxation, supported by a researcher-developed information booklet. The technique involved sequentially tensing and relaxing muscle groups. Relaxation exercise audio recordings prepared by the Turkish Psychological Association were uploaded to participants' mobile devices to guide home practice. Participants were instructed to practice every morning for eight weeks. Weekly telephone calls provided follow-up throughout the intervention period. | Behavioural | Progressive Muscle Relaxation Group |
Primary outcome
Change in Diabetes-Related Quality of Life Score from Baseline to Week 8
Time frame: Baseline and week 8
Quality of life was assessed using the Ferrans and Powers Quality of Life Index, Diabetes Version. The instrument assesses satisfaction with different aspects of life and the importance attributed to those aspects. It provides a total score and scores for health and functioning, social and economic, psychological/spiritual, and family domains. Higher scores indicate better quality of life. Assessments were conducted at baseline and week 8.
2 secondary outcomes
1. Anxiety
Time frame: Baseline and week 8
Change in Depression Score from Baseline to Week 8
Time frame: Baseline and week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data with other researchers.
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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.
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 Progressive Muscle Relaxation in people with Type 2 Diabetes Mellitus, run by Gul Dural 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 5 inclusion and 2 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 15 Oct 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?
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?
Change in Diabetes-Related Quality of Life Score from Baseline to Week 8 (time frame: Baseline and week 8). 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 15 Oct 2026.