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Not yet recruiting NCT07247903

The Impact of Patient Education Delivered Through Virtual Reality

No phase Interventional Knee Arthroplasty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: education.
Who it may be relevant to
Registry conditions: Knee Arthroplasty. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Virtual Reality-Based Education on Preoperative Surgical Fear, Postoperative Pain and Patient Satisfaction in Patients Undergoing Knee Arthroplasty: A Randomized Controlled Trial

Overview

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

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.

Interventions

  • Other 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

Primary outcome measures

  • Surgical Fear Scale [Time frame: one day before the surgery]
Secondary outcome measures (1)
  • Visual Analog Scale-Pain [Time frame: 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07247903 · AnkaraYBU-HEM-KAH-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗