NCT06814613

Brief Summary

Aim: The study aims to examine the effect of progressive relaxation exercises administered to nursing students via telenursing on sleep quality after the February 6 earthquake in Turkey. Materials and Methods: The study was conducted as a randomized controlled study. The study population consisted of first-, second-, and third-year nursing students enrolled in the nursing departments of two universities located in eastern Turkey, who were residing in one of the 11 cities affected by the earthquake during the February 6 Turkey earthquake. The sample included 86 students (40 experimental, 46 control). While the control group received no intervention, the experimental group received progressive relaxation exercises for 20 minutes every night for 4 weeks, 1 hour before the routine bedtime (or the time they planned to go to sleep) by making a video call (via Google Meet application) with the student. Data were collected using a personal information form and the Pittsburgh Sleep Quality Scale. Descriptive statistical methods (frequency, percentage, arithmetic mean, standard deviation), independent groups t-test, and paired t-test were used to evaluate the data. Conclusion: The research results can showed that progressive relaxation exercises could be an effective intervention in improving sleep quality after an earthquake. Additionally, conducting these exercises via telenursing could contribute significantly to the sustainability and control of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

January 25, 2025

Last Update Submit

February 3, 2025

Conditions

Keywords

EarthquakeNursing studentsProgressive relaxation exercisesSleepTelenursing

Outcome Measures

Primary Outcomes (1)

  • Pittsburgh Sleep Quality Index

    Pittsburgh Sleep Quality Index The scale was developed by Buysse et al. and validated in Turkish by Agargün et al. (Buysse et al., 1989; Agargün, 1996). Of the 24 items on the scale, 18 are included in the evaluation. The scale consists of 7 sub-dimensions: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficacy, Sleep Disturbances, Use of Sleep Medication, and Daytime Dysfunction. Each sub-dimension is scored between 0-3, and the total scale score ranges from 0 to 21. An increase in the scale score indicates a decline in sleep quality. The results are evaluated in three categories: 0-5 points indicate healthy sleep, 6-10 points indicate poor sleep, and above 10 points indicate chronic sleep disturbance. The Cronbach's alpha internal consistency coefficient for the scale was calculated as 0.80 by Ağargün (1996).

    3 month

Study Arms (2)

Intervention

EXPERIMENTAL

Progressive relaxation exercises were conducted by the researcher, who had received training in this area. The students were informed in detail about the study's implementation process. For the next 4 weeks, every night, 1 hour before the routine bedtime (or the time when the student planned to sleep), a video call (via the Google Meet application) was made with the student, and progressive relaxation exercises were performed. The exercise took approximately 20 minutes and followed the implementation protocol (Davis et al., 2008; Payne, 2000). Group interviews were conducted for students with similar sleep hours. They were asked to move to a ventilated room away from noise so that the exercises could be practiced comfortably and not interrupted.

Other: Exercise

control

NO INTERVENTION

No intervention was applied to the control group in the study. Data collection forms were filled out only at the beginning and in the fourth week of the study.

Interventions

For the next 4 weeks, every night, 1 hour before the routine bedtime (or the time when the student planned to sleep), a video call (via the Google Meet application) was made with the student, and progressive relaxation exercises were performed. The exercise took approximately 20 minutes and followed the implementation protocol (Davis et al., 2008; Payne, 2000). Group interviews were conducted for students with similar sleep hours. They were asked to move to a ventilated room away from noise so that the exercises could be practiced comfortably and not interrupted.

Also known as: Progressive relaxation exercises practice
Intervention

Eligibility Criteria

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

You may qualify if:

  • The study included students who were in one of the 11 cities affected by the Turkey earthquake,
  • did not have a medical diagnosis related to sleep disorders,
  • were not using any sleep medications or long-acting treatments,
  • had access to necessary equipment for telenursing such as the internet, computer, or phone,
  • were enrolled in the first, second, or third year of the nursing program.

You may not qualify if:

  • The fourth-grade nursing students were excluded from the study because they undergo internship training and work night shifts,
  • which may affect their sleep patterns and quality and create a difference between them and other students.
  • Students with any diagnosis related to sleep and those with any psychiatric diagnosis were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu university

Malatya, Center, 44100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Randomized controlled experimental model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2025

First Posted

February 7, 2025

Study Start

December 1, 2023

Primary Completion

February 15, 2024

Study Completion

March 30, 2024

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Participants' data were collected for research purposes only according to the ethical principle of condentiality and protection. Therefore, it cannot be shared.

Locations