Effects of Different Relaxation Therapies on Pain and Sleep in Hip and Knee Arthroplasty Patients

January 22, 2026 updated by: Meltem Soydan, Bartın Unıversity

Comparison of the Effects of Virtual Reality-based and Traditional Relaxation Therapy on Postoperative Pain and Sleep Quality in Patients Undergoing Hip and Knee Replacement Surgery

Hip and knee replacement surgery is commonly performed in older adults. After surgery, many patients experience pain, limited movement, and sleep problems. These difficulties can make daily activities such as walking or climbing stairs more challenging and may reduce quality of life during recovery.

Relaxation exercises are often used to help reduce pain and improve sleep after surgery. Virtual reality (VR) is a technology that provides a multisensory experience and may help people relax by shifting their attention away from pain and discomfort.

This study is designed to compare two different relaxation approaches used after hip and knee replacement surgery. One group of patients will perform relaxation exercises using virtual reality, while another group will perform traditional relaxation exercises. The study will examine pain levels and sleep quality in both groups.

The results of this study may help to better understand whether virtual reality-based relaxation can be used as an alternative or supportive method for managing pain and sleep problems after joint replacement surgery.

Study Overview

Status

Status

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

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 (Estimated)

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.
82

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Center
      • Bartın, Center, Turkey (Türkiye), 74100
        • Recruiting
        • Bartın State Hospital
        • Contact:

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:

  • Those who volunteered to participate in the research,
  • 18 years and older,
  • No diagnosed mental or sleep problems, epilepsy, or depression,
  • No vision, hearing, or speech problems,
  • Those who speak Turkish,
  • Knee and hip replacement surgery ,
  • No active nausea or vomiting prior to the virtual reality application,
  • According to the Numerical Rating Scale, the patient reports pain.
  • Those receiving analgesia treatment according to clinical protocol,
  • Anyone who owns a mobile phone or tablet capable of playing videos, using any brand of internet provider,
  • Patients who had not previously practiced breathing exercises were included .

Exclusion Criteria:

  • Having a problem that prevents communication,

  • Being admitted to the ward where the surgery and study were performed at another center,

    . Complications develop after knee and hip replacement surgery,

  • Nausea and vomiting may occur during the procedure.
  • Wanting to withdraw from the research,
  • Experiencing chronic pain.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Virtual Reality-Based Relaxation Group
Participants receive relaxation exercises delivered through virtual reality technology following hip and knee replacement surgery. The intervention is provided during the postoperative period in addition to standard care.
Behavioral: Virtual Reality-Based Relaxation
Relaxation exercises delivered through virtual reality technology during the postoperative period following hip and knee replacement surgery.
Active Comparator: Traditional Relaxation Therapy Group
Participants receive traditional relaxation exercises without virtual reality following hip and knee replacement surgery. The intervention is provided during the postoperative period in addition to standard care.
Behavioral: Traditional Relaxation Therapy
Standard relaxation exercises performed without virtual reality during the postoperative period following hip and knee replacement surgery.

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
Postoperative Pain Intensity
Time Frame: Postoperative three days period
Pain intensity will be assessed using Numerical Rating Scale (0-10 points) in patients undergoing hip and knee replacement surgery. 0 represents no pain and 10 represents the most severe pain.
Postoperative three days period

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 Quality
Time Frame: Postoperative three days period
Sleep quality will be evaluated using Richards Campbell Sleep Questionnaire (0-100 points) during the postoperative period.The scale uses a score range of "0-25" to indicate very poor sleep and a score range of "76-100" to indicate very good sleep. The total score is evaluated based on 5 items; item 6, which assesses the noise level in the environment, is excluded from the total score evaluation. As the score obtained from the questionnaire increases, it is interpreted that the patients' sleep quality has improved.
Postoperative three days period

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sevim Çelik, Professor, Bartin University Health Science Faculty

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.
November 1, 2024

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.
January 15, 2026

Study Completion (Estimated)

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.
January 30, 2026

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).
December 23, 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.
January 15, 2026

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.
January 21, 2026

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.
January 23, 2026

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.
January 22, 2026

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.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • BartınU-SBF-MS-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

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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

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