NCT07758361

Brief Summary

Knee osteoarthritis, which occurs after degeneration of the knee joint with age, is common in women after 65 years of age and surgical methods are generally used in the treatment of deformity, pain and limitation of movement. This surgical procedure is different from other surgical procedures. It takes a long time to perform activities of daily living and return to quality life. At the same time, pain, anxiety and sleep disorders are among the most common problems in the postoperative period. In addition to pharmacological methods, non-pharmacological methods (listening to music, watching movies, daydreaming, humor, virtual reality application, laughter) are used to reduce these problems. In recent years, especially virtual reality application has started to be used as a distraction-based approach in recent years. Virtual reality is the artificial creation of a three-dimensional environment through computer technology. In this application, it is ensured that the individual feels that he/she is a part of the created virtual environment with immersive environments that seem effective. This study was planned to determine the effect of virtual reality glasses on pain, anxiety and sleep in patients undergoing total knee arthroplasty. The study will be conducted with participants who are willing to participate in the study and whose consent has been obtained. One group will receive virtual reality goggles (experiment) and the other group will receive standard care. Control group They will be asked to evaluate their level of "Anxiety and Pain" before and two days after Total Knee Arthroplasty surgery and their level of Sleep at their convenience after waking up the next day. Experimental group In addition to the standard care and practices applied to the participants in the control group, you will be asked to watch videos of relaxing nature scenes wearing "Virtual Reality Goggles". These videos last 30 minutes. You will be asked to fill in the same scales for two days preoperatively and two days postoperatively as the participants in the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

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 5, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity measured by the Numeric Rating Scale (NRS)

    Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), with higher scores indicating greater pain.

    Immediately before and immediately after each VR session on postoperative day 1 and postoperative day 2

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Participants received standard postoperative care plus a nurse-guided virtual reality intervention.

Device: Virtual Reality Group

Control Group

NO INTERVENTION

Participants received standard postoperative care according to the orthopaedic clinic protocol.

Interventions

Participants received standard postoperative care plus a nurse-guided virtual reality intervention.

Virtual Reality Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • underwent elective primary total knee arthroplasty for knee osteoarthritis; (3) were able to communicate in Turkish; (4) were mobilized on the first postoperative day according to the hospital's standard postoperative care protocol; (5) reported a postoperative pain score of ≥4 on the Numeric Rating Scale; and (6) provided written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Since it is a single-blind randomized controlled trial, the nurse and the statistician evaluating the data will not be informed about the experimental and control groups.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Patients who did not receive virtual reality goggles (control group) will receive standard care and treatment. They will be asked to fill out the "State Anxiety Inventory Scale" and "Pain Visual Comparison Scale" form on the first and second postoperative day, and the "Richards-Campbell Sleep Scale" form when appropriate after waking up the next day. Virtual reality goggles were applied (experimental group): In addition to the standard care and treatment practices applied to the patients in the control group, they will be asked to watch videos with relaxing nature views with virtual reality glasses. These videos will be shown for 20-25 minutes twice a day, 2-3 hours after surgery and on the second day, in the morning and evening hours (before sleep) without analgesic administration (at least one hour). Scales will be administered to determine pain, anxiety and sleep levels immediately before and after wearing the virtual glasses.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist Prof

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 11, 2026

Study Start

January 5, 2024

Primary Completion

March 30, 2024

Study Completion

December 30, 2024

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations