An interventional study of Progressive Muscle Relaxation in Type 2 Diabetes Mellitus, sponsored by Gul Dural. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Gul Dural · Not applicable, Interventional, and Supportive care
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.
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.
9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 80 is close to the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
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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.
Exclusion Criteria:
Severe diabetes-related complications, such as neuropathy, retinopathy, or nephropathy.
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.
Behavioral: Progressive Muscle Relaxation
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.
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.
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.
Time frame: Baseline and week 8
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.
Time frame: 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.
Time frame: Baseline and week 8
Plan to share: No — There is currently no plan to share individual participant data with other researchers.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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