NCT07876401

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
Last Updated

October 15, 2026

Status Verified

October 1, 2026

Enrollment Period

1 year

First QC Date

October 9, 2026

Last Update Submit

October 9, 2026

Conditions

Keywords

Progressive muscle relaxation; Type 2 diabetes; anxiety; depression; quality of life; mixed-methods study

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and week 8

Secondary Outcomes (2)

  • 1. Anxiety

    Baseline and week 8

  • Change in Depression Score from Baseline to Week 8

    Baseline and week 8

Study Arms (2)

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.

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.

Interventions

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.

Progressive Muscle Relaxation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Firat University, Faculty of Health Sciences, Department of Nursing

Elâzığ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Anxiety DisordersDepression

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 9, 2026

First Posted

October 15, 2026

Study Start

September 10, 2024

Primary Completion

September 10, 2025

Study Completion

April 15, 2026

Last Updated

October 15, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

There is currently no plan to share individual participant data with other researchers.

Locations