NCT07247903

Brief Summary

Objective: A randomized controlled trial was designed to determine the effect of virtual reality-based education provided to patients undergoing knee arthroplasty on preoperative surgical fear, postoperative pain, and patient satisfaction. Materials and Methods: The study was designed as a randomized controlled experimental study, with the group receiving animation-based patient education via virtual reality goggles serving as the experimental group and the group receiving routine patient education at the clinic serving as the control group. Research data will be collected using a patient characteristics form prepared by the researcher based on a literature review, a surgical fear scale, a visual analog scale, and a patient education satisfaction scale. Virtual reality glasses will be used as the application tool in the study.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet 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 Progress50%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 12, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

January 22, 2026

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

November 18, 2025

Last Update Submit

January 21, 2026

Conditions

Keywords

virtual realitypainsurgical fearpatient satisfactionknee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Surgical Fear Scale

    It is used to determine the fear levels of patients undergoing elective surgery. The scale consists of eight items on an 11-point Likert scale and is scored from zero to ten. The scale consists of two subscales that measure fear related to the short- and long-term outcomes of surgery. Items 1-4 measure fear of the short-term outcomes of the surgical procedure, while items 5-8 measure fear of the long-term outcomes of the surgical procedure. These questions address fears related to the surgical operation, anesthesia, pain, side effects, deterioration of health as a result of the surgical operation, failure of the surgical operation, inability to fully recover after the surgical operation, and prolongation of the recovery process. The items on the scale are rated on a scale of "0: not afraid at all" to "10: very afraid." The highest possible score on the scale is eighty, and the lowest is zero.

    one day before the surgery

Secondary Outcomes (1)

  • Visual Analog Scale-Pain

    Upon arrival at the clinic after surgery, pain assessment will be performed using the VAS at 15 and 30 minutes, and at 1, 2, 4, 8, 12, and 24 hours.

Other Outcomes (1)

  • Patient Education Satisfaction Scale

    It will be performed 24 hours after surgery.

Study Arms (2)

Control

NO INTERVENTION

Patients who agree to participate in the study will be asked to complete a patient characteristics form. Patients in the control group will not receive any specific education from the researcher during the preoperative period. These patients will receive the clinic's routine patient education prior to surgery. After consulting with the nurses who provided the routine patient education at the clinic, the surgical fear scale will be administered. Upon arrival at the clinic after surgery, pain assessment will be performed using the VAS at 15 and 30 minutes, 1, 2, 4, 8, 12, and 24 hours. Since the data collection process for our study ends at 24 hours, the patient satisfaction scale will be completed at that time. Data collection is expected to take a total of 15-20 minutes.

Experimental

OTHER

The researcher will provide patients with information about the virtual reality headset. The virtual reality headset will be disinfected before use for each patient. Patients in the experimental group will receive patient education using an animation-based video method with the virtual reality (VR) headset one day before the surgery. The training will be provided in a quiet, calm environment where the training will not be interrupted, in their own rooms for patients staying in single rooms, and in the nurse's room for patients staying in rooms with 2 or more beds. Patient education will be provided using the animation-based video method, and after answering the patient's questions, the surgical fear scale will be applied. Upon arrival at the clinic after surgery, pain assessment will be performed using the VAS at 15 and 30 minutes, 1, 2, 4, 8, 12, and 24 hours. Since the data collection process for our study ends at 24 hours, the patient satisfaction scale will be completed at that ti

Other: education

Interventions

The preparation of patient education using animation-based video methods will first involve the researcher developing a scenario based on the literature, covering the preoperative preparation process, deep breathing and coughing exercises, Respiratory Exercise Device use, pain management, potential postoperative complications, wound care, mobilization, and the rehabilitation process. After the educational content and its suitability are reviewed and approved by 5 experts and its content validity is established, it will be forwarded to a graphic design expert for the preparation of the animation. Regular feedback will be obtained throughout the video preparation process, and the work will be closely monitored. The voiceover for the animation video will be done by the researcher.

Experimental

Eligibility Criteria

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

You may qualify if:

  • Be 18 years of age or older,
  • Agree to participate in volunteer work,
  • Have no communication problems in terms of vision, hearing, and perception,
  • Be able to read, speak, and understand Turkish,
  • Have no fear of enclosed spaces.

You may not qualify if:

  • Bilateral Total Knee Arthroplasty.
  • Admission to the clinic on the day of surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainPatient Satisfaction

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Kübra AYMELEK HACIOSMANOĞLU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kübra AYMELEK HACIOSMANOĞLU

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding of the Study and Prevention of Bias Assignment to control and experimental groups will be performed by an independent statistician to prevent bias and ensure confidentiality, and a blinding technique will be applied. Thus, selection bias will be controlled by random assignment and concealment of randomization. Since the intervention will be administered by the researcher, double-blinding will not be possible, but the data will be coded as 'A' and 'B' by the researcher and transferred to the computer. Furthermore, to prevent bias, the analysis of the coded data will be performed by an independent statistician outside the research team. The study protocol will follow the SPIRIT guidelines, and the reporting of the research will be conducted according to the Consolidated Standards of Reporting Trials (CONSORT) 2017 checklist.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomization Patients who meet the inclusion criteria for the study will be numbered sequentially starting from 1 and assigned using the block randomization method. These numbers will be randomly and equally divided into two groups-the control group and the experimental group-using a computer-assisted program.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

January 12, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 22, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

I don't want to share until the app is finished