Effect of Virtual Reality on Preoperative Anxiety

NCT ID: NCT04547322

Last Updated: 2020-09-14

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

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-05-30

Brief Summary

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The aim of this study was to determine the effect of virtual reality (VR) on the preoperative anxietyof patients undergoing colorectal surgery.

Detailed Description

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The sample of this study consisted of 86 patients in experimental and control groups. The experimental group received VR application in the preoperative period for 10 minutes. Anxiety level was assessed with the Anxiety Specific to Surgery Questionnaire (ASSQ) and measured with physiological responses of anxiety such as systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR) and peripheral oxygen saturation (SpO2) before and after VR application.

Conditions

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Preoperative Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, parallel, two arm, randomized controlled clinical trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
The researchers involved in the data analysis and statistics stages were blinded to the group assignment, too. However, those involved in the running of the study were not blinded. Also, the person who performed the measurements was not blinded due to the nature of VR application.

Study Groups

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VR application group

The experimental group received VR application in the preoperative period for 10 minutes.

Group Type EXPERIMENTAL

VR application group

Intervention Type OTHER

During the transfer from the general surgery clinic to the operating room (3-5 minutes) and in the surgery waiting room, the VR aplication group were asked to wear a virtual reality headset (VR BOX 2) and headphones minimizing sound loss (Earpods with Apple Lightning Connector) that are compatible with mobile phones with IOS operating system. The VR headset and the headphones were controlled by a mobile phone (iPhone 7 Plus). The researchers had the patients watch three-dimensional videos (e.g. underwater world, museum trips, forest and park walks, beach trips, and space travel) for 10 minutes with their preferred background and relaxing music.

Control group

The control group received the routine procedure in the unit clinic where the study was conducted. The routine procedure of the unit includes patients are taken to the operating room on a stretcher and wait on the stretcher in the surgery waiting room until the operation room is prepared.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VR application group

During the transfer from the general surgery clinic to the operating room (3-5 minutes) and in the surgery waiting room, the VR aplication group were asked to wear a virtual reality headset (VR BOX 2) and headphones minimizing sound loss (Earpods with Apple Lightning Connector) that are compatible with mobile phones with IOS operating system. The VR headset and the headphones were controlled by a mobile phone (iPhone 7 Plus). The researchers had the patients watch three-dimensional videos (e.g. underwater world, museum trips, forest and park walks, beach trips, and space travel) for 10 minutes with their preferred background and relaxing music.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* conscious,
* orientated and cooperated patients who could speak and understand Turkish,
* who had no psychiatric diseases,
* who were 18 years old and older,
* who were scheduled for elective colorectal surgery for the first time,
* who did not take any sedative drugs before surgery, and
* who gave written and oral permission to participate in the study

Exclusion Criteria

* had language problems,
* underwent emergency surgery,
* were over 65 years of age and
* refused to participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mersin University

OTHER

Sponsor Role lead

Responsible Party

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Gulay ALTUN UGRAS

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gulay Altun Ugras, PhD

Role: PRINCIPAL_INVESTIGATOR

Mersin University, Nursing Faculty

Locations

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Mersin University Hospital

Mersin, Yenisehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Gulay Ugras

Identifier Type: -

Identifier Source: org_study_id

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