NCT06867575

Brief Summary

When the literature is examined, it is observed that the effects of progressive relaxation exercises on pain, anxiety and sleep quality have been frequently investigated in different populations. Studies conducted with nursing students focus on dysmonorrhea and clinical anxiety and stress . A limited number of studies have focused on the quality of life of students . There is no study examining the effects of progressive relaxation exercises on sleep quality, psychological endurance and quality of life together. Therefore, the aim of our study is to examine the effects of progressive relaxation exercises applied to nursing students on sleep quality, psychological endurance and quality of life. It is thought that our study results will contribute to the literature in terms of their originality.

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

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

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

January 25, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

February 25, 2025

Last Update Submit

August 25, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Average sleep quality score

    Pittsburgh Sleep Quality Index: This scale is a 19-item self-report scale that evaluates sleep quality and disturbances in the past month. The PSQI consists of 24 questions, 19 of which are answered by the participant, while 5 questions are answered by the spouse or roommate. The scale is divided into 7 main components: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Sleep Efficiency, Sleep Disturbances, Sleep Medication Use, and Daytime Dysfunction. Each component is scored between 0 and 3, and these scores give a total result between 0 and 21. A total score above 5 indicates poor sleep quality.

    First week, 4th week

  • Average resilience scores for Adults

    The scale containing a total of 33 items is in 5-point Likert type. The scale consists of 6 sub-dimensions. Of these, 'structural style' (3, 9, 15, 21) and 'perception of future' (2, 8, 14, 20) are measured with 4 items each; 'family harmony' (5, 11, 17, 23, 26, 32), 'self-perception' (1, 7, 13, 19, 28, 31) and 'social competence' (4, 10, 16, 22, 25, 29) are measured with 6 items each and 'social resources' (6, 12, 18, 24, 27, 30, 33) are measured with 7 items. In the scale, positive and negative features are on separate sides in order not to cause biased evaluation. Five separate boxes were created for the answers. The scoring method was left free in evaluating the level of psychological resilience as low or high. The validity and reliability Cronbach alpha coefficient of the scale was determined as 0.86 (1) by Basım and Çetin (2011), and 0.89 in this study. Considering that psychological resilience increases as the scores increase, the scoring is done as 1-2-3-4-5 from left to right

    First week, 4th week

  • Avarage Quality of Life scores

    SF-36 Quality of Life Scale: The scale consists of 36 items and these provide the assessment of different health dimensions under 8 subscales: 1) Physical function (10 items) 2) Social function (2 items) 3) Role limitations due to physical problems (4 items) 4) Role limitations due to emotional problems (3 items) 5) Mental health (5 items) 6) Energy/vitality (4 items) 7) Pain (2 items) 8) General health perception (5 items) (Ware \& Sherbourne, 1992). The scale is assessed by considering the last 4 weeks. A form evaluating the last 1 week was also applied in order to create the acute form. The assessment is made in Likert type (three-point-six-point) except for items 4 and 5; items 4 and 13 and 5 are answered in a yes/no format. Instead of giving a single total score, the scale gives a total score for each subscale separately. The second question of the scale, 'Compared to last year, how do you evaluate your health now?' only includes one-year changes, but this question is not included

    First week, 4th week

Study Arms (2)

Progressive relaxation group

EXPERIMENTAL

Progressive Relaxation Exercises

Other: Progressive Relaxation Exercise

Control group

NO INTERVENTION

The students who formed the control group and accepted to participate in the study will be asked to fill out the "Descriptive Characteristics Form", "Pittsburgh Sleep Quality Index (PSQI)", "Adult Resilience Scale", and "SF-36 Quality of Life Scale" in the first meeting. After filling out the data collection tools in the first meeting in the classroom, no intervention will be made. At the end of the 4th week follow-up period, separate data collection forms and post-test results will be obtained. The control group will be given a progressive relaxation exercise audio recording and booklets with written instructions stated in the audio recording.

Interventions

Progressive Relaxation Exercise Steps

Progressive relaxation group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being a student in the Department of Nursing
  • Being willing to participate in the study
  • Not having a chronic disease that may prevent exercise (COPD, heart failure, etc.)
  • Not having a hearing problem
  • Not having a psychiatric diagnosis (major depression, anxiety disorders, etc.) and not using medication for anxiety or depression
  • Having a computer and technological devices at home
  • Being able to use a mobile phone (IOS-Android)
  • Having internet access
  • Being able to speak Turkish
  • Not having used techniques such as meditation, hypnosis, yoga for the last 6 months before the study
  • Not having a neurological, systemic, or psychiatric disease.

You may not qualify if:

  • Nursing students who do not volunteer to participate in the study,
  • Those who have any health problems during the application process,
  • Those who cannot continue the study for any reason,
  • Those who want to withdraw from the study with their own consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necibe

Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Disease Progression

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Necibe DAĞCAN ŞAHİN, PhD

    Kütahya Health Sciences University, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Burcu NAL, PhD

    Kütahya Health Sciences University, Faculty of Health Sciences

    STUDY DIRECTOR
  • Sema ÜSTÜNDAĞ, PhD (c)

    Kütahya Health Sciences University, Faculty of Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Students will be randomly assigned (using online randomization software) to experimental and control groups. Students will know that they are participating in the study and the interventions that will be applied to them, but they will be blinded by not knowing which group they are in. The study data will be collected by a second researcher who is blinded to the groups. In the statistical analysis of the data, the groups will be labeled as group 1 and group 2, and the third researcher will be blinded when evaluating the results. Thus, the third researcher will be blinded to the study groups. In order to avoid bias in the evaluation of the results, the first researcher, who is not blinded, will not participate in any stage of the evaluation process.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This research is a randomized controlled trial planned to examine the effects of progressive relaxation exercises on sleep quality, psychological resilience and quality of life in nursing students.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Nursing

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 10, 2025

Study Start

January 25, 2025

Primary Completion

February 25, 2025

Study Completion

April 30, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations