NCT07354542

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

November 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

December 23, 2025

Last Update Submit

January 22, 2026

Conditions

Keywords

Postoperative PainSleep QualityVirtual Reality

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Intensity

    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 Outcomes (1)

  • Sleep Quality

    Postoperative three days period

Study Arms (2)

Virtual Reality-Based Relaxation Group

EXPERIMENTAL

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

Traditional Relaxation Therapy Group

ACTIVE COMPARATOR

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

Interventions

Relaxation exercises delivered through virtual reality technology during the postoperative period following hip and knee replacement surgery.

Virtual Reality-Based Relaxation Group

Standard relaxation exercises performed without virtual reality during the postoperative period following hip and knee replacement surgery.

Traditional Relaxation Therapy Group

Eligibility Criteria

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

You may qualify if:

  • Those who volunteered to participate in the research,
  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın State Hospital

Bartın, Center, 74100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

OsteoarthritisPain, PostoperativeSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Sevim Çelik, Professor

    Bartin University Health Science Faculty

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 21, 2026

Study Start

November 1, 2024

Primary Completion

January 15, 2026

Study Completion

January 30, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations