The Effect of the Operating Room Environment on Patients Experienced With Virtual Reality Glasses Before Surgery

March 21, 2025 updated by: İmren Erer, Saglik Bilimleri Universitesi

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Today, virtual reality is used in many areas such as medical diagnosis and treatment by reflecting three-dimensional images animated on the computer as if it were a real experience. Procedural pain, facilitating interventional procedures with a game-based video demonstration in children, and outpatient surgeries such as circumcision surgery can be used to provide patients with this "real world" experience, its use has also become widespread in areas such as wound care and in nursing education due to the increase in malpractice cases . In line with patient experiences, the benefits of virtual reality technology have been documented in the literature and its use in nursing care is increasing . Informing the patient to improve the quality of care, managing pain during painful interventional procedures, and reducing surgery-related fear reduces wound healing and hospital stay, especially in surgical patients . In the literature, patients' pre-operative problems such as lack of knowledge about the surgery, operating room environment, surgical procedures, etc. It is reported that they experience anxiety and fear related to many factors. It also emphasizes the importance of informing the patient before surgery within the scope of Enhance Recovery After Surgery (ERAS) procedures (Joshi & Kehlet, 2019). In line with ERAS protocols, preoperative education and information have been proven to provide positive postoperative recovery. Informing the patient about the operating room environment is the most important element in accelerating surgical recovery. The operating room environment can be seen as a stress factor for patients. Therefore, in this study, we aimed to examine the effect of informing patients about the operating room environment, supported by visuals, on the patient's fear and perceptions of care. In addition, it is thought that this information and experience will affect the patient's vital signs and that the patient's need for premedication will also change. It is thought that the results of this study will positively affect patient outcomes by improving the quality of patient care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Operating Room Environment Experienced by Patients
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in surgical fear levels of patients in the operating environment after simulation experience with virtual reality glasses
Time Frame: Preoperative Use of Virtual Reality After Simulation
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
Time Frame: Preoperative Use of Virtual Reality After Simulation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Emine Parlak, 2, Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ierer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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