The Effect of Exergames on Sleep Quality (EXSLEEPQUALITY)

April 29, 2025 updated by: Feyza Demir Bozkurt, Bartın Unıversity

The Effect of Exergames on Sleep Quality in Nursing Students: A Randomized Controlled Trial

University students are at risk of developing insufficient sleep and poor lifestyle behaviors. Sleep-related problems are frequently seen in nursing students. Regular exercise has a positive effect on sleep quality. In recent years, developing technological opportunities have led educators to seek different solutions in education, guidance, and counseling services aimed at protecting and improving the health of individuals. As the popularity of VR technology increases, it has a high potential to increase physical activity and improve sleep quality in university students. In the current literature, studies examining the level of physical activity and sleep quality of nursing students using VR virtual glasses are limited. This study aims to examine the effect of virtual reality exercise applications on nursing students' sleep quality and physical activity. This study was planned as a pre-test and post-test control group study. The study population comprises 60 students from the Department of Nursing and the Faculty of Health Sciences. Since the study population is accessible, no sample calculation will be made, and all students who volunteer to participate in the study and meet the inclusion criteria will be included. Randomization will divide students who meet the inclusion criteria into experimental and control groups. The aim of the study and the application will be explained to the students in the experimental group at the first meeting. They will be asked to sign written informed consent, and they will fill out data collection forms. Three sessions are planned for each student in the experimental group. Each session is planned to be held with an average interval of 96-120 hours (every 4-5 days). Data collection forms will be repeated for the students in the experimental group at the end of the third session. The aim of the study will be explained to the students in the control group at the first meeting. They will be asked to sign written informed consent, and they will fill out data collection forms. At the end of 14 days, actigraphs will be received from the control group, and post-tests will be applied. Descriptive statistics of the study data will be reported by giving numbers, percentages, mean, and standard deviation. Student t-tests, ANOVA or Mann-Whitney U, and Kruskal Wallis tests will be used to compare groups regarding the normal distribution of the data. Pearson chi-square test and Fisher exact chi-square test will be used to compare nominal or ordinal data groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bartın, Turkey
        • Bartın University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being a nursing program student,
  • Willingness to participate in the study.

Exclusion Criteria:

  • Having any cardiovascular, cerebrovascular, or other physical conditions that could prevent participation in a 30-minute exercise session.
  • Being diagnosed with a sleep disorder
  • Using medications that effect sleep, the autonomic nervous system, or the cardiovascular system, such as hypnotics
  • Having any upper extremity injury or similar condition that would prevent the use of an actigraph device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Play the Oculus Quest 2 games
Other: Play the Oculus Quest 2
Every three to four days (roughly 72 to 96 18 19 hours), a session was held. Students were required to use the Oculus Quest 2 and touch controllers to play immersive exergames for thirty minutes during each session. In each session, they were asked to play the games Dance Central (https://www.dancecentral.com/ ) and CREED: Rise to Glory (which the researchers loaded into the Oculus Quest 2) via the Meta Quest Gaming platform (https://www.meta.com/tr-tr/experiences/creed-rise-to27 glory-championship-edition/2366245336750543/ ).
No Intervention: Control
Standard physical activity recommendations

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
sleep quality
Time Frame: Baseline and 8th day
Pittsburgh Sleep Quality Index (PSQI): The Pittsburgh Sleep Quality Index (PSQI), developed by Buysse et al. and validated for reliability in Turkish, will be used to assess the usual sleep quality of the experimental and control groups to evaluate their homogeneity before the intervention (Ağargün et al., 1996). The PSQI evaluates seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The sum of these seven components forms the total PSQI score. The total PSQI score ranges from 0 to 21, with lower scores indicating better sleep quality.
Baseline and 8th day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep efficiency
Time Frame: Baseline and 8th day
Wrist actigraphy: Wrist actigraphy was used to assess the objective sleep, which is frequently used to assess each person's level of physical activity and sleep quality in adults. Each participant in the study wore an actigraph (GT3X-Plus three-axis model, ActiGraph LLC, Pensacola, FL, USA) on their non-dominant wrist. The device was adjusted to 1-minute epochs and 30 Hz in the current study. Activity counts were analyzed using ActiLife software (version 6.13.6) based on the sleep diary entries, and the Cole-Kripke algorithm was used to score sleep on actigraphy data in order to predict bedtime and waking time. The following metric was extracted from the actigraphy-based data: sleep efficiency (SE).
Baseline and 8th day
Wake after sleep onset (WASO)
Time Frame: Baseline and 8th day
Wrist actigraphy: Wrist actigraphy was used to assess the objective sleep, which is frequently used to assess each person's level of physical activity and sleep quality in adults. Each participant in the study wore an actigraph (GT3X-Plus three-axis model, ActiGraph LLC, Pensacola, FL, USA) on their non-dominant wrist. The device was adjusted to 1-minute epochs and 30 Hz in the current study. Activity counts were analyzed using ActiLife software (version 6.13.6) based on the sleep diary entries, and the Cole-Kripke algorithm was used to score sleep on actigraphy data in order to predict bedtime and waking time. The following metric was extracted from the actigraphy-based data: wake after sleep onset (WASO).
Baseline and 8th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bartın Unıversity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BU-NURSE-FDB-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

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