Clinical trial NCT05796076: Virtual Reality to Reduce Anxiety and Pain During Suturing Procedure
Official title: Virtual Reality Intervention on Anxiety and Pain Among Adult Patients Ubdergoing an Awake Minor Suture: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suture
Keywords: Anxiety
Pain
Virtual reality
Suturing
Lead sponsor: Tuen Mun Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Tung Wah College
First posted: 2023-04-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention and control group
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety
timeFrame: Baseline, and 5 minutes after the completion of the procedure
Secondary outcomes:
measure: Pain Level
timeFrame: During the procedure
measure: Satisfaction level
timeFrame: 5 minutes after the completion of the procedure
measure: Blood pressure
timeFrame: Baseline, during and 5 minutes after the completion of the procedure
measure: Pulse rate
timeFrame: Baseline, during and 5 minutes after the completion of the procedure
measure: Additional local analgesic requirements
timeFrame: During the procedure
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital-Emergency department
Study officials:
affiliation: Tuen Mun Hospital
name: KO SHUK YEE, DN
role: PRINCIPAL_INVESTIGATOR
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