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Clinical Trials/NCT04547322
NCT04547322CompletedNot Applicable

The Effect of Virtual Reality on Preoperative Anxiety in Patients Undergoing Colorectal Surgery

Mersin University1 site in 1 country86 target enrollmentStarted: June 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
86
Locations
1
Primary Endpoint
Change Anxiety Specific to Surgery Questionnaire score

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • The study included
  • 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

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

Arms & Interventions

VR application group

Experimental

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

Intervention: VR application group (Other)

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.

Outcomes

Primary Outcomes

Change Anxiety Specific to Surgery Questionnaire score

Time Frame: 10 minute

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.

Secondary Outcomes

  • Change systolic blood pressure(10 minute)
  • Change heart rate(10 minute)
  • Change diastolic blood pressure(10 minute)
  • Change respiratory rate(10 minute)
  • Change peripheral oxygen saturation(10 minute)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gulay ALTUN UGRAS

Associate Professor

Mersin University

Study Sites (1)

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