The Impact of Patient Education Delivered Through Virtual Reality

NCT ID: NCT07247903

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-12

Study Completion Date

2026-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Type of Study The study was designed as a randomized controlled trial to determine the effect of virtual reality training provided to patients undergoing knee arthroplasty on preoperative surgical fear, postoperative pain and patient satisfaction.

Location and General Characteristics of the Study The study will be conducted at the Orthopedics and Traumatology Clinic of Ankara Gazi University Health Research and Application Center with patients who meet the study criteria.

Study Population and Sample The study population will consist of patients hospitalized at the Orthopedics and Traumatology Clinic of Ankara Gazi University Health Research and Application Center. Within this scope, the sample of the study will consist of patients selected by randomization from among individuals who will undergo knee arthroplasty surgery, in accordance with the inclusion and exclusion criteria of the study.

Blinding and Prevention of Bias in the Study Assignment to the control and experimental groups will be performed by an independent statistician to prevent bias and ensure confidentiality, and a blind 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 transferred to the computer by the researcher and coded as 'A' and 'B'. Additionally, to prevent bias, the analysis of coded data will be conducted by an independent statistician outside the research team. The study protocol will follow the SPIRIT guidelines, and the research will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) 2017 checklist.

Data Collection Tools 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 (VAS-pain), and a patient education satisfaction scale. Virtual reality glasses will be used as the application tool in the study.

Data Collection In order to conduct the research, after obtaining approval from the Ethics Committee of Ankara Yildirim Beyazit University and institutional permission from the Ankara Gazi University Health Research and Application Center, the researcher will explain the purpose of the study to the patients in the experimental and control groups and obtain an 'Informed Consent Form' from them before starting the application. The forms to be administered to patients will be completed by the researcher through face-to-face interviews.

Content of the Animation-Based Patient Education Provided To prepare patient education using animation-based video methods, the researcher will first prepare a scenario based on literature, covering the surgical preparation process, deep breathing and coughing exercises, Respiratory Exercise Device use, pain management, possible 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 validity is confirmed, it will be sent 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 researcher will provide the voiceover for the animated video.

Research Plan A preliminary study group will be formed with patients who meet the research criteria and agree to participate in the study. After obtaining an 'Informed Consent Form' from the patients, the patient identification form will be completed. One day before surgery, patient education will be provided using an animation-based video method with virtual reality (VR) glasses. After receiving patient education and having their questions answered, 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 time.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Arthroplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental

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

Group Type OTHER

education

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

education

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Bilateral Total Knee Arthroplasty.
* Admission to the clinic on the day of surgery.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

KAHacıosmanoğlu

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kübra AYMELEK HACIOSMANOĞLU

Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kübra AYMELEK HACIOSMANOĞLU

Role: CONTACT

+ 5546704908

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AnkaraYBU-HEM-KAH-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.