Virtual Reality to Reduce Anxiety and Pain During Suturing Procedure

April 11, 2024 updated by: Ko Shuk Yee, Tuen Mun Hospital

Virtual Reality Intervention on Anxiety and Pain Among Adult Patients Ubdergoing an Awake Minor Suture: A Pilot Randomized Controlled Trial

Background: In emergency departments, suturing is a common procedure but often causes anxiety and pain. Virtual reality (VR) intervention has been reported as a relaxing measure.

Objective: The study aims to examine the effects of VR intervention on anxiety, pain, physiological parameters, local anaesthesia requirements and satisfaction in Chinese adult patients undergoing wound closure in emergency departments in Hong Kong

Hypothesis:VR can alleviate anxiety and pain experienced by Chinese adult patients undergoing wound-closure procedures, the intervention can decrease extra local anesthesia requirements and physiological parameters during the procedures, and the intervention can significantly increase satisfaction during wound-closure procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Suturing is one of the most common procedure in the emergency department, however, it often provokes anxiety and pain. 1-2 Failure to manage patients' anxiety and pain during wound closure can cause difficulties for health care providers to complete the procedures and reduce the success rates. 3 Experience of anxiety and pain may also increase the need for medication, reduce patients' satisfaction rate and cause negative physiological parameters such as increased blood pressure and heart rate. 4-5.

Traditionally, nonpharmacological intervention such as listening to music, chatting, and guided imagery is applied to reduce patient's anxiety and pain. However these measures fail to provide patients with significant distraction because patients would inevitably see the procedure that causes considerable distress during the procedure. Thus, the development of further strategies to provide a significant distraction to alleviate patients' anxiety and pain during suturing is warranted.

With advanced technologies, virtual reality (VR) provides significant distraction. Clinical trials indicate that use of VR achieved a statistically significant decrease in anxiety and pain in different operations such as hand 6, lipoma incision 7, Gynecology 8, and debridement 9. However, only a handful of studies conducted among adult patient with ambulatory laceration repairing examined the effectiveness of VR in anxiety and pain. To the best of our knowledge, no study specifically focus on the effects of VR on anxiety and pain in Chinese adult patients undergoing an awake suture in emergency room in Hong Kong. Eighty participants will be assigned to the experimental group or to the control group by randomization.

After written informed consent will be obtained from patients, the baseline data (T0) will be obtained from the participants including sociodemographic, anxiety, blood pressure, and pulse rate. Subsequently, randomization is conducted. Throughout the procedure (T1), the additional medication requirements and physiological parameters will be recorded. The anxiety, pain and satisfaction and physiological parameters will also be recorded after the procedure. Data will be analyzed using IBM SPSS 23.0. Descriptive statistics, including frequency, percentage, mean and standard deviation will be used to describe the data. Chi-square tests compare categorical variables, and independent t-tests compare continuous variables. Generalized Estimation Equation will be used to examine the effectiveness of the VR intervention versus the control group will be evaluated by comparing the study outcomes. Two-tailed tests will be used with a significant level of 0.05.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital-Emergency department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Conscious, oriented
  2. Adult patient (age between 18 and 65 years) with scheduled to receive an awake minor suture
  3. Ability to communicate in Chinese, and read and write Chinese language
  4. Hemodynamic stability as evidenced by blood pressure between 90 to 140 mmHg systolic and 60 to 90 mmHg diastolic before the procedure

Exclusion Criteria:

  1. Have visual, hearing or cognitive impairment
  2. History of senile dementia, seizure disorder, motion sickness, psychiatric disorders as indicated in medical record
  3. Have injury or infection above the neck
  4. Known to be on contact precaution

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Participants in the control group will be received standard care
Device: Virtual reality
Participants in the intervention group will be received VR during the suturing procedure. Virtual reality is a three dimensions of width, height and depth that is generated digitally in a computer-generated environment that allows a user to interact with it 16.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Baseline, and 5 minutes after the completion of the procedure

The Chinese version of the State Trait Anxiety scale is used to measure anxiety levels of the patients. It contains two separate scales for state and trait anxiety.

The first part (state anxiety) evaluates a transitory emotional state that is influenced by intense emotional situations and varies in intensity over time. The second part (trait anxiety) demonstrates a relatively stable anxious tendency and is not significantly influenced by emotionally intense situations. Each item is rated on a 4-point Likert scale, with total scores from 20 to 80. The high the score indicates the high a higher level of anxiety. The STAI-C is validated in Hong Kong and is found to have a high degree of internal consistency (Alpha = 0.9). Participants will be required to complete the state form at 5 minutes after the completion of the procedure in this study 10-12
Baseline, and 5 minutes after the completion of the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Level
Time Frame: During the procedure
Pain is measured by visual analogue scales (VAS). VAS is a commonly used method for quantifying pain. The scale comprises a 10cm line with terms representing the extremes of pain at either end. The patient estimates pain by placing a mark on the line. The distance from the zero point is then measured. The VAS has been shown to be a valid tool for the measurement of psychological and health variables such as pain and satisfaction which had been used in clinical studies widely 13-15.
During the procedure
Satisfaction level
Time Frame: 5 minutes after the completion of the procedure
Satisfaction is measured by visual analogue scales (VAS). VAS is a commonly used method for quantifying pain. The scale comprises a 10cm line with terms representing the extremes of pain at either end. The patient estimates satisfaction by placing a mark on the line. The distance from the zero point is then measured. The VAS has been shown to be a valid tool for the measurement of psychological and health variables such as pain and satisfaction which had been used in clinical studies widely 13-15.
5 minutes after the completion of the procedure
Blood pressure
Time Frame: Baseline, during and 5 minutes after the completion of the procedure
A standard blood pressure monitor is used to measure patients' blood pressure. The blood pressure is recorded as mmHg
Baseline, during and 5 minutes after the completion of the procedure
Pulse rate
Time Frame: Baseline, during and 5 minutes after the completion of the procedure
A standard pulse oximetry is used to measure patients' pulse rate. The pulse rate is recorded as beat per minute (bpm)
Baseline, during and 5 minutes after the completion of the procedure
Additional local analgesic requirements
Time Frame: During the procedure
The frequency of extra local analgesic use (1 % Lidocaine) is recorded
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuen Mun Hospital

Collaborators

Tung Wah College

Investigators

  • Principal Investigator: KO SHUK YEE, DN, Tuen Mun Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2023

Primary Completion (Actual)

August 9, 2023

Study Completion (Actual)

August 9, 2023

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NTWC/REC/22003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is only a pilot study and will be modified after the pilot study. We will share it later on in the main study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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