NCT07177573

Brief Summary

The purpose of this study is to investigate the effects of virtual reality on pain, anxiety, and comfort during continuous passive motion following total knee arthroplasty

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Sep 2025

Status
not yet 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 Progress67%
Sep 2025Oct 2026

Study Start

First participant enrolled

September 1, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

September 10, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

Total Knee ArthroplastyVirtual RealityContinuous Passive Movement TherapyPainAnxietyComfortPatient

Outcome Measures

Primary Outcomes (1)

  • Pain, Anxiety, and Comfort Levels during Continuous Passive Motion

    Pain and comfort levels will be assessed using the Visual Analog Scale (VAS, 0-10), where 0 indicates no pain/comfort and 10 indicates worst pain/maximal comfort. Anxiety will be measured using the State-Trait Anxiety Inventory (STAI). The effects of virtual reality during CPM on pain, anxiety, and comfort will be compared between the VR and control groups.

    Immediately before and after each CPM session on postoperative day 2 and day 3

Study Arms (2)

Experimental

EXPERIMENTAL

Virtual Reality

Other: Virtual Reality

Control

NO INTERVENTION

Interventions

The demographic information of the participants will be collected through face-to-face interviews. Pain and comfort levels will be assessed using the Visual Analog Scale (VAS) prior to the intervention. Additionally, anxiety levels will be measured with the Spielberger State-Trait Anxiety Inventory, and vital signs will be recorded. Patients included in the study will be informed about the use of virtual reality (VR) goggles and introduced to the videos that will be viewed. During the Continuous Passive Motion (CPM) application, patients will be positioned in a semi-Fowler's position with a pillow placed under the head for support. Through virtual reality, patients will watch the video Forest Walk along the Middle Fork Snoqualmie River Trail with Relaxing Sounds and the accompanying sounds will be delivered through headphones integrated into the goggles.

Experimental

Eligibility Criteria

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

You may qualify if:

  • First-time total knee arthroplasty Postoperative day 2 Mobilized before CPM application Adequate vision and hearing to use the virtual reality device Oriented to person, place, and time No cognitive, sensory, or verbal communication impairments No history of vertigo No hypertension Not using sedative, anxiolytic, or similar medications Willing to voluntarily participate in the study

You may not qualify if:

  • Any diagnosed psychiatric disorder
  • History of vertigo
  • Hypertension
  • Using sedative, anxiolytic, or similar medications
  • Poor general condition
  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Emel Yılmaz, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 17, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share