An interventional study of Virtual reality in Suture, sponsored by Tuen Mun Hospital. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Tuen Mun Hospital · Not applicable, Interventional, and Health services research
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.
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.
Tuen Mun Hospital is the lead sponsor of 24 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
Time frame: Baseline, and 5 minutes after the completion of the procedure
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.
Time frame: During 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 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.
Time frame: 5 minutes after the completion of the procedure
Blood pressure
A standard blood pressure monitor is used to measure patients' blood pressure. The blood pressure is recorded as mmHg
Time frame: Baseline, during and 5 minutes after the completion of 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)
Time frame: Baseline, during and 5 minutes after the completion of the procedure
Additional local analgesic requirements
The frequency of extra local analgesic use (1 % Lidocaine) is recorded
Time frame: During the procedure
Plan to share: No — It is only a pilot study and will be modified after the pilot study. We will share it later on in the main study
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Tuen Mun Hospital