Virtual Reality to Reduce Anxiety and Pain During Suture Procedure

Study Overview
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Brief Summary
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The goal of this clinical trial is to examine the effectiveness of virtual reality (VR) in alleviating anxiety and pain among adult patients undergoing an awake minor suture. The main questions it aims to answer are: How effective is VR intervention in reducing anxiety among adult patients undergoing an awake minor suture? How effective is VR intervention in reducing pain level among adult patients undergoing an awake minor suture? How effective is VR intervention in reducing the medication requirement of adult patients undergoing an awake minor suture? How effective is VR intervention in reducing the physiological parameters including blood pressure and pulse rate, in adult patients undergoing an awake minor suture? How effective is VR intervention in enhancing procedure satisfaction in adult patients undergoing an awake minor suture? A RCT will be adopted. Participants will be randomly assigned to either an experimental group or control group.

Detailed Description
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Suture is a frequent medical procedure for treatment and management of wound bleeding in the emergency department. However, the procedure often provoke anxiety and pain. 1-2 Failure to manage patients' anxiety and pain during the medical procedures 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 used to reduce patient's anxiety and pain. However these measures fail to provide significant distraction for patient with suture 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 suture 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 control group by the computer generated random numbers. After written informed consent are 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 by computer generated random codes. Throughout the procedure (T1), the additional medication use and physiological parameters will be recorded. The pain and satisfaction will also be assessed by visual analogue scales 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. RMANOVA compare change over time between the two groups. Two-tailed tests will be used with a significant level of 0.05.

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

Conditions
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Suture

Intervention / Treatment
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* Device: Virtual reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>Participants in the control group will be received standard care | Device: Virtual reality<br>* Participants in the intervention group will be received VR during the suture 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 in this study 10-12 | Baseline, pre-procedure | 
| 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 in this study 10-12 | immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Level | 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. | Immediately after the procedure | 
| Satisfaction level | 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 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. | immediately after the procedure | 
| Blood pressure | A standard blood pressure monitor is used to measure patients' blood pressure. The blood pressure is recorded as mmHg | Baseline, pre-procedure | 
| Blood pressure | A standard blood pressure monitor is used to measure patients' blood pressure. The blood pressure is recorded as mmHg | During the procedure | 
| Blood pressure | A standard blood pressure monitor is used to measure patients' blood pressure. The blood pressure is recorded as mmHg | Immediately after the procedure | 
| Pulse rate | A standard pulse oximetry is used to measure patients' pulse rate. The pulse rate is recorded as beat per minute (bpm) | Baseline, pre-procedure | 
| Pulse rate | A standard pulse oximetry is used to measure patients' pulse rate. The pulse rate is recorded as beat per minute (bpm) | During the procedure | 
| Pulse rate | A standard pulse oximetry is used to measure patients' pulse rate. The pulse rate is recorded as beat per minute (bpm) | Immediately after the procedure | 
| Additional local analgesic (1% Lidocaine) requirements | The frequency of extra local analgesic use (1 % Lidocaine) is recorded | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, Anxiety, Pain, Suture