Effect of Virtual Reality on Preoperative Anxiety

NCT04547322 | Completed

• 1 other identifier: Gulay Ugras
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preoperative Anxiety

Keywords

colorectal surgery; virtual reality; nurse

Outcome Measures

Primary Outcomes (1)

• Change Anxiety Specific to Surgery Questionnaire score

  The psychological response of patients to preoperative anxiety was evaluated with Anxiety Specific to Surgery Questionnaire. With a total of 10 items, responses are made on a five-point Likert scale format ranging from 1 (do not agree at all) to 5 (completely agree). Anxiety Specific to Surgery Questionnaire score is obtained by adding the answers to all items (minimum score=10; maximum score=50). The increase in the scale score indicates that the level of anxiety increases. The researchers administered Anxiety Specific to Surgery Questionnaire to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement.

  10 minute

Secondary Outcomes (5)

• Change systolic blood pressure

  10 minute

• Change diastolic blood pressure

  10 minute

• Change heart rate

  10 minute

• Change respiratory rate

  10 minute

• Change peripheral oxygen saturation

  10 minute

Study Arms (2)

VR application group

EXPERIMENTAL

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

Other: VR application group

Control group

NO INTERVENTION

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.

Interventions

VR application group 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.

VR application group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University Hospital

Mersin, Yenisehir, 33343, Turkey (Türkiye)

Location

Study Officials

• Gulay Altun Ugras, PhD

  Mersin University, Nursing Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: prospective, parallel, two arm, randomized controlled clinical trial

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 14, 2020
• Study Start: June 1, 2018
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: September 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)