Virtual Reality to Reduce Anxiety and Pain During Suturing Procedure

NCT05796076 | Completed

• 1 other identifier: NTWC/REC/22003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Suture

Keywords

Anxiety; Pain; Virtual reality; Suturing

Outcome Measures

Primary Outcomes (1)

• Anxiety

  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 Outcomes (5)

• Pain Level

  During the procedure

• Satisfaction level

  5 minutes after the completion of the procedure

• Blood pressure

  Baseline, during and 5 minutes after the completion of the procedure

• Pulse rate

  Baseline, during and 5 minutes after the completion of the procedure

• Additional local analgesic requirements

  During the procedure

Study Arms (1)

Control group

OTHER

Participants in the control group will be received standard care

Device: Virtual reality

Interventions

Virtual reality DEVICE

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.

Control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tuen Mun Hospital: lead
• Tung Wah College: collaborator

Study Sites (1)

Tuen Mun Hospital-Emergency department

Hong Kong, Hong Kong

Location

Related Publications (16)

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  PMID: 30422942 BACKGROUND

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  PMID: 27864995 BACKGROUND

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  PMID: 25463769 BACKGROUND

• Robleda G, Sillero-Sillero A, Puig T, Gich I, Banos JE. Influence of preoperative emotional state on postoperative pain following orthopedic and trauma surgery. Rev Lat Am Enfermagem. 2014 Oct;22(5):785-91. doi: 10.1590/0104-1169.0118.2481.

  PMID: 25493674 BACKGROUND

• Hoxhallari E, Behr IJ, Bradshaw JS, Morkos MS, Haan PS, Schaefer MC, Clarkson JHW. Virtual Reality Improves the Patient Experience during Wide-Awake Local Anesthesia No Tourniquet Hand Surgery: A Single-Blind, Randomized, Prospective Study. Plast Reconstr Surg. 2019 Aug;144(2):408-414. doi: 10.1097/PRS.0000000000005831.

  PMID: 31348351 BACKGROUND

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  PMID: 30256662 BACKGROUND

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  BACKGROUND

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  PMID: 18427228 BACKGROUND

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  BACKGROUND

• Shek DTL. The factorial structure of the Chinese version of the state-trait anxiety inventory: a confirmatory factor analysis. Psychol Edu Meas. 1991;51(4):985-997. doi:10.1177/001316449105100418

  BACKGROUND

• Shek DT. The Chinese version of the State-Trait Anxiety Inventory: its relationship to different measures of psychological well-being. J Clin Psychol. 1993 May;49(3):349-58. doi: 10.1002/1097-4679(199305)49:33.0.co;2-j.

  PMID: 8315037 BACKGROUND

• Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

  PMID: 4139420 BACKGROUND

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  PMID: 24921952 BACKGROUND

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  PMID: 11748392 BACKGROUND

• Moskaliuk J, Kimmerle J, Cress U. Virtual reality 2.0 and its application in knowledge building. In handbook of research on web 2.0, 3.0, and X. O: technologies, business and social applications. USA: IGI Global, 2010.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• KO SHUK YEE, DN

  Tuen Mun Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Investigator will not be involved the recruitment and data collection. Outcome assessor will be masked
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advanced Practice Nurse

Model Details: Intervention and control group

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 3, 2023
• Study Start: February 3, 2023
• Primary Completion: August 9, 2023
• Study Completion: August 9, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)