NCT06666465

Brief Summary

This study was planned as a randomized controlled experimental study with a pretest-posttest design to examine the effect of the operating room environment experience of preoperative patients using virtual reality glasses on the patients' preoperative surgical fear level and care perceptions.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
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

August 15, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

August 23, 2024

Last Update Submit

March 21, 2025

Conditions

Keywords

Clinical practice

Outcome Measures

Primary Outcomes (2)

  • Change in surgical fear levels of patients in the operating environment after simulation experience with virtual reality glasses

    Change in Anxiety and Stress Levels during the care of patients undergoing surgery Simulation of the operating room environment to patients using virtual reality glasses will affect patients' stress and anxiety levels in the operating room. This situation will be evaluated. The scale consists of 8 items, scored from 0 to 10, and is an 11-point Likert-type scale. Each item is scored as 0 "not at all afraid" and 10 "very afraid". The scale consists of two sub-dimensions, each consisting of four items. These indicate the fear of short-term and long-term consequences of surgery; items 1-4 in the scale measure the fear of short-term consequences of surgery, while items 5-8 measure the fear of long-term consequences of surgery.

    Preoperative Use of Virtual Reality After Simulation

  • change in patients' perceptions of nursing care

    The change in patients' nursing care perception scores will be measured. There are 15 statements on the Likert-type scale regarding the quality of nursing care. It is requested to mark one of the 15 statements that make up the scale: I agree = 5, I somewhat agree = 4, I am undecided = 3, I disagree = 2, I strongly disagree = 1 and no response = 0. The score given for each item is taken as basis. Thus, a minimum of 15 and a maximum of 75 points can be obtained from the scale. The increase in the total score obtained from the scale indicates that the patient is satisfied with the nursing care.

    Preoperative Use of Virtual Reality After Simulation

Study Arms (1)

Operating Room Environment Experienced by Patients

EXPERIMENTAL

This study was planned as a randomized controlled experimental study in the pre-test post-test design in order to examine the effect of the operating room environment experience of patients using virtual reality glasses before surgery on the level of surgical fear experienced by patients before surgery and their perception of care.

Other: Operating Room Environment Experienced by Patients Wearing Virtual Reality Glasses Before Surgery The Effect of Surgery Experience on Surgical Fear Level and Care Perceptions

Interventions

The video, which will be shot for patients to experience the operating environment, will include premedication, an operating room and a post-operative care unit. In the video, the operating room environment will be recorded by the researcher with a voice introduction. The image was shot with a 360-degree camera (Insta 360 One X2), edited with an application program (Insta 360 Studio) and then uploaded to the YouTube VR Pro application as a secret video. The video will be shown to the glasses via an Android phone on the internet via YouTube. People wearing glasses at the screening will be able to look in any direction they want thanks to the 360-degree video. They will be able to watch the video again if they want.

Operating Room Environment Experienced by Patients

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility Detailspatients undergoing surgery
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years or older
  • Agreeing to participate in the research
  • Having elective cholecystectomy surgery
  • Knowledge of Turkish and no communication barriers
  • Having surgery for the first time and not having seen the operating room environment

You may not qualify if:

  • Being 18 years of age or younger
  • Refusal to participate in the research
  • Having undergone surgery and having seen the operating room environment before Not knowing Turkish and having any communication barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İmren Erer

İnönü, Eskişehir, 26670, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Addab, S., Hamdy, R., & Thorstad, K. (2022). Use of Virtual Reality in Managing Pediatric Prosedural Pain and Anxiety: an Integrative Literature Review. Journal of Clinical Nursing, 31(21-22), s. 3032-3059. Ahern, M., Dean, L., Stoddard, C., Agrawai, A., Kim, K., Cook, C., & Garcia, A. (2020). The Effectviveness of Virtual Reality in Patients with Spinal Pain: Systematic Review and Meta- Analysis. Pain Practice, 20(6), s. 656-675. Baytar, Ç., & Bollucuoğlu, K. (2021). Effect of Virtual Reality on Preoperative Anxiety Inpatients Undergoing septorhinoplasty. Brazilian Journal of Anesthesiology, 1(744276), s. 1-6. Bağdigen Kaya, M., & Karaman Özlü, Z. (2019). Elektif Cerrahi Bekleyen Hastalarda Cerrahi Korkunun Sosyal Destek Algısı ile İlişkisinin Belirlenmesi. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 22(4), s. 281-290.

    BACKGROUND

Study Officials

  • Emine Parlak, 2

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Patients participating in the study will be included in a group by gender-based stratified block randomization method. Patients in the intervention group will experience the operating room environment with VR glasses (n: 30), while patients in the control group (n: 30) will receive standard nursing care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

August 23, 2024

First Posted

October 30, 2024

Study Start

August 15, 2024

Primary Completion

December 16, 2025

Study Completion

December 20, 2025

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations