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Completed

NCT Number: NCT04547322

Effect of Virtual Reality on Preoperative Anxiety

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

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Key information

Conditions

Preoperative Anxiety

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mersin University Hospital

Mersin, Yenisehir, 33343, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Change systolic blood pressure

    Time frame: 10 minute

    Determine patients' physiological responses (systolic blood pressure) of preoperative anxiety after virtual reality application

    The researchers measured systolic blood pressure 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. At the same time, their systolic blood pressure values were followed on the portable monitor (Vismo, Nihon Kohden, Germany).

  2. Change diastolic blood pressure

    Time frame: 10 minute

    Determine patients' physiological responses (diastolic blood pressure) of preoperative anxiety after virtual reality application

    The researchers measured diastolic blood pressure 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. At the same time, their diastolic blood pressure values were followed on the portable monitor (Vismo, Nihon Kohden, Germany)

  3. Change heart rate

    Time frame: 10 minute

    Determine patients' physiological responses (heart rate) of preoperative anxiety after virtual reality application

    The researchers measured heart rate 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. At the same time, their heart rate were followed on the portable monitor (Vismo, Nihon Kohden, Germany)

  4. Change respiratory rate

    Time frame: 10 minute

    Determine patients' physiological responses (respiratory rate) of preoperative anxiety after virtual reality application

    The researchers measured respiratory rate 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. At the same time, their respiratory rate were followed on the portable monitor (Vismo, Nihon Kohden, Germany)

  5. Change peripheral oxygen saturation

    Time frame: 10 minute

    Determine patients' physiological responses ( peripheral oxygen saturation) of preoperative anxiety after virtual reality application

    The researchers measured peripheral oxygen saturation 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. At the same time, their peripheral oxygen saturation were followed on the portable monitor (Vismo, Nihon Kohden, Germany)

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 14, 2020
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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