Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT07247903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Patient Education Delivered Through Virtual Reality
Sponsor:
Ankara Yildirim Beyazıt University
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: