The Effect of Using Virtual Reality Glasses on Surgical Fear and Anxiety

NCT ID: NCT06165861

Last Updated: 2025-04-11

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-14

Study Completion Date

2023-10-16

Brief Summary

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The purpose of this clinical study is to evaluate the effect of using virtual reality glasses on the surgical fear and anxiety levels of patients undergoing open heart surgery on the morning of surgery. The main hypotheses are:

1. The surgical fear level of patients who use virtual reality glasses on the morning of surgery is lower than patients who do not use virtual reality glasses.
2. The anxiety level of patients who use virtual reality glasses on the morning of surgery is lower than patients who do not use virtual reality glasses.

Before the surgery, study group patients will be asked to watch videos using virtual reality glasses.

Detailed Description

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The group distribution of the patients was made using the Random Allocation Software (Version 2.0.0) program and the patients were divided into two groups: the study group and the control group.

Patients in the study group were asked to watch videos using virtual reality glasses between the first, second and third evaluation before surgery.

The researcher visited the patients in the cardiovascular surgery ward before the surgery and reported that the patients in the study group would watch video (including nature sounds such as bird sounds, water sounds, etc) with virtual reality glasses. Patients in the control group were informed that the normal service protocol would be applied.

The Surgical Fear Scale was developed to measure the surgical fear levels experienced by patients before surgery. To assess surgical fear, patients are asked to rate their fear level for each question with a number ranging from 0 - 'I am not afraid at all' to 10 -'I am very afraid'. Visual Analog Scale - To evaluate anxiety, patients are asked to mark the anxiety they perceive on a line ranging from 0 -'no anxiety' to 10 -'highest level of anxiety'. The total score of the surgical fear scale is obtained by summing the scores of all scale questions; The lowest score that can be obtained is 0 and the highest score is 80. A lower score indicates that patients experience less surgical fear during their activities. Higher scores indicate a higher level of surgical fear.

To perform the first evaluation in the study group, the researcher went to the patient and evaluated the patient introduction form and surgical fear and anxiety levels. Then, the researcher nurse explained that they were waiting for the operating room team to arrive and gave the patients brief information about the virtual reality glasses. Then, entrances and exits to the room were restricted to ensure that the room was quiet enough to watch videos and away from distracting elements. Patients were then asked to watch the video carefully and focus on the video sounds. Virtual reality glasses were fitted to the patients and videos were started to be watched. The nurse researcher remained in the patient's room until the video ended. At the end of the video, the glasses were taken from the patient and disinfected, and the researcher nurse left the patient room. Then, a second evaluation was made by the service nurse. The third evaluation was made by the researcher nurse when the patients were taken down to the operating room waiting room.

In the control group, the first evaluation was made by the researcher nurse. Then, normal service protocol was applied to the control group patients and a second evaluation was made by the service nurse before going down to the operating room waiting room. The third evaluation was made by the researcher nurse in the operating room waiting room.

Conditions

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Open Heart Surgery Virtual Reality Preoperative Anxiety Fear Nurse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The research will be conducted using randomized controlled, experimental type and single-blind research methods. For this purpose, after the data are collected, they will be coded as A and B groups, so the researcher who will make the research statistics will analyze the data without knowing the study and control groups. Randomization method will be used to determine the groups. For this, the patients who meet the study criteria and volunteer will be assigned to the groups using the randomization program 'Random Allocation Software 2.0' according to the order of hospitalization.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The data analyse is going to be completed by a independent researcher.

Study Groups

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Experimental (with VR-G)

The patients in this procedure watched video with using VR-G for approximately 6 minutes at the surgical clinic before going surgery.

Group Type EXPERIMENTAL

Experimental (with VR-G)

Intervention Type OTHER

Watching video with using VR-G before undergoing open heart surgery

Standard (No VR-G)

The patients took the standart protocol of the surgical clinic and didn't watch video with using VR-G

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental (with VR-G)

Watching video with using VR-G before undergoing open heart surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Volunteering to participate in the research,
* Will undergo open surgery,
* Will undergo planned surgical intervention,
* Being over 18 years of age,
* No visual impairment,
* No hearing impairment,
* No speech impediment,
* Lack of a psychiatric diagnosis was included.

Exclusion Criteria

* Having an emergency surgical procedure
* Having a visual impairment
* Having a hearing impairment
* Being under 18 years of age
* Lack of mental health
* Having a speech impediment
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trakya University

OTHER

Sponsor Role lead

Responsible Party

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Seher Ünver

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seher Ünver

Role: PRINCIPAL_INVESTIGATOR

Trakya University

Tuba Erol Akar

Role: PRINCIPAL_INVESTIGATOR

Trakya University

Locations

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Seher Ünver

Edirne, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Erol Akar T, Unver S. Effectiveness of Virtual Reality Glasses on Surgical Fear and Anxiety in Patients Before Open-heart Surgery: A Double-blind Randomized Controlled Trial. J Perianesth Nurs. 2025 Jun;40(3):682-688. doi: 10.1016/j.jopan.2024.08.011. Epub 2024 Nov 30.

Reference Type DERIVED
PMID: 39614857 (View on PubMed)

Other Identifiers

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2021-GOBAEK-452

Identifier Type: -

Identifier Source: org_study_id

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