NCT06792123

Brief Summary

The aim of this study was to examine the effect of virtual reality application on anxiety and quality of recovery at different times (preoperatively and intraoperatively) in patients undergoing total knee replacement.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

January 19, 2025

Last Update Submit

January 19, 2025

Conditions

AnxietyRecovery Quality

Keywords

virtual realityanxietyrecovery qualitytotal knee replacementnursing

Outcome Measures

Primary Outcomes (2)

  • Anxiety

    Beck Anxiety Scale

    Pre-test before surgery; post-test two hours after surgery

  • Recovery quality

    quality of recovery-15 (QoR-15)

    Pre-test before surgery; post-test two hours after surgery

Study Arms (3)

group 1

EXPERIMENTAL

pre-op VR application group

Other: pre-op VR application group

Group 2

EXPERIMENTAL

Intra-op VR application group

Other: intra-op VR application group

Control

NO INTERVENTION

Standart care and treatment

Interventions

pre-op VR application groupOTHER

VR application group during preoperative process

group 1
intra-op VR application groupOTHER

VR application group during intraoperative process

Group 2

Eligibility Criteria

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

You may qualify if:

  • Over the age of 18
  • No psychiatric medication
  • No mental and cognitive disabilities
  • Those who underwent Total Knee Replacement,

You may not qualify if:

  • Patients with visual and hearing impairment
  • Receiving general anesthesia
  • Experiencing complications during surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs Unıversity

Samsun, Atakum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Özge İşeri Assistant Professor, PhD

    Ondokuz Mayıs University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Ondokuz Mayıs University

Study Record Dates

First Submitted

January 19, 2025

First Posted

January 24, 2025

Study Start

April 21, 2024

Primary Completion

December 30, 2024

Study Completion

April 30, 2025

Last Updated

January 24, 2025

Record last verified: 2025-01

Locations

TU(1)