NCT07038109

Brief Summary

This randomised controlled trial aims to investigate the effects of progressive muscle relaxation exercises (PMRE) on depression, anxiety, stress, future-oriented attitudes, and biopsychosocial responses in nursing students. The study was conducted between June 2024 and June 2025 with students enrolled in the Nursing Department. Data collection took place between January and March 2025. When selecting participants, a list of participants meeting the inclusion criteria was created using snowball sampling. A total of 104 students were randomly divided into experimental and control groups of 52 students each. Data were collected using the DASS-21, Future Orientation Scale, and Biopsychosocial Response Scale for Nursing Students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable depression

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

June 18, 2025

Last Update Submit

March 10, 2026

Conditions

Keywords

Progressive Muscle RelaxationPsychological InterventionNursing StudentsMental Health PromotionStress ManagementDepressionAnxietyPsychological StressBiopsychosocial ResponseFuture OrientationUniversity StudentsRandomized Controlled TrialRelaxation Techniquesprogressive relaxation exercise

Outcome Measures

Primary Outcomes (1)

  • Change in depression, anxiety, and stress levels measured by DASS-21

    The Depression Anxiety Stress Scale - 21 (DASS-21) will be used to assess changes in psychological symptoms. It consists of three subscales measuring depression, anxiety, and stress. The scale will be administered at baseline (pre-test) and after the 4-week intervention (post-test).

    Baseline and Week 4

Secondary Outcomes (2)

  • Change in future orientation levels measured by the Future Orientation Scale

    Baseline and Week 4

  • Change in biopsychosocial response levels measured by the Biopsychosocial Response Scale for Nursing Students

    Baseline and Week 4

Study Arms (2)

Participants in this group received progressive relaxation exercises (PRE)

EXPERIMENTAL

A structured progressive muscle relaxation program based on Jacobson's technique was implemented. The intervention lasted four weeks, with participants practicing three times per week in 45-minute sessions. The exercises were initially demonstrated in person by the researcher to ensure correct technique. Subsequently, participants followed pre-recorded audio instructions during each session to maintain consistency. The intervention aimed to reduce psychological symptoms and support biopsychosocial well-being in nursing students.

Other: Progressive relaxation exercise

Control group

NO INTERVENTION

Participants in this group did not receive any behavioral or psychological intervention during the study period. They continued their normal academic activities without any additional support or guidance. No relaxation techniques or recordings were provided to this group. Data were collected at the same time points as the experimental group to ensure consistency in measurement.

Interventions

The intervention was based on Jacobson's Progressive Muscle Relaxation (PMR) technique. Participants in the experimental group practiced PMR three times per week for four weeks. Each session lasted approximately 45 minutes and was conducted in a quiet environment. In the first session, the researcher provided face-to-face instruction. Subsequent sessions were guided by standardized audio recordings, and the participants were followed through scheduled online video calls. The intervention aimed to reduce depression, anxiety, and stress symptoms and to promote biopsychosocial well-being in nursing students.

Also known as: progressive muscle relaxation, progressive muscle relaxation exercises, Progressive Relaxation Technique, Jacobson's Progressive Muscle Relaxation, Muscle Relaxation Exercise, Progressive Relaxation Training, Jacobson's progressive relaxation technique
Participants in this group received progressive relaxation exercises (PRE)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being registered in the Department of Nursing
  • Voluntary consent to participate in the study

You may not qualify if:

  • Having joint or muscle pain, or any condition that may interfere with performing relaxation exercises
  • Having a diagnosis of cancer or any chronic disease
  • Having a psychiatric disorder that may interfere with obtaining valid results from the study (e.g., major depressive disorder, severe anxiety disorders, serious psychiatric conditions)
  • Currently receiving antidepressant, anxiolytic, or similar psychiatric treatment
  • Regular use of non-pharmacological methods such as yoga, psychotherapy, or similar practices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersStress, PsychologicalPsychological Well-BeingPsychophysiologic Disorders

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal SatisfactionNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants were blinded to their group allocation during the intervention process. The outcome assessor (statistician) was also blinded to group assignment during data analysis to reduce bias.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study used a two-arm, parallel assignment design. Participants were randomly assigned to either the experimental group, which received progressive muscle relaxation exercises, or the control group, which received no intervention. A pretest-posttest design was used to assess outcomes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, PhD in Nursing

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 26, 2025

Study Start

January 1, 2025

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to ethical restrictions and the scope of the study. The research was conducted as part of a TÜBİTAK 2209-A student project and approved only for academic use. No explicit consent or ethical approval was obtained for external data sharing.

Locations