This study is a pilot randomized controlled trial (RCT) conducted at Tin Shui Wai Hospital to evaluate the effectiveness of a mobile-based mindfulness intervention in reducing preoperative anxiety among patients scheduled for elective surgery.
Aim: To determine if a 4-week mindfulness program delivered via a mobile app can reduce preoperative anxiety, compared to standard care.
Design:
Parallel-arm RCT with 40 participants (20 in each group). Participants are randomly assigned to either the intervention group (mobile-based mindfulness intervention + usual care) or control group (usual care only).
The intervention uses a free and anonymous mindfulness mobile app developed by The University of Hong Kong.
Primary Outcome:
Preoperative anxiety level on the day of surgery, will be assessed using the STAI-S questionnaire.
Secondary Outcomes:
Postoperative pain levels, use of analgesics, emergency department revisit rate, and user satisfaction with the app.
Data Collection:
Anxiety levels are measured at baseline and before surgery. Pain levels and analgesic use are recorded postoperatively. Emergency visits and usability feedback are collected post-discharge.
Significance:
The study addresses a gap in evidence for mobile mindfulness interventions in Chinese surgical patients.
Findings may support the integration of low-cost, app-based mindfulness into preoperative care.
adult (age>= 18 years old)
scheduled to undergo non-emergency surgery under general anesthesia (GA)
use of smart phone
able to understand the Chinese language and express their feelings sufficiently
unable to provide informed consent
history or current treatment for psychological complaints
serious physical or psychological co-morbidities
hearing or vision impairment
Parallel
mobile-based mindfulness intervention
BehavioralPatients will be provided with usual care by surgeon, anesthetist and perioperative team, and they will be asked to install a validated mindfulness based mobile app during the PAS session. Orientation and teaching on the use of the mobile app will be carried out by research team. Return demonstration by patients will be performed at the end to ensure they are capable to use the app at home independently. A minimum of 4-week intervention duration with session lengths of 1 min, 3 days per week is set for this study. Patients will be distributed a dairy log to record the frequency and duration of mindfulness practice and submit to the researcher on the day of admission. Follow up on patient's progress through phone call or whatsapp will be provided by the researcher to ensure patient's adherence to the intervention on a bi-weekly basis.
Pre-operative anxiety level
Pre-operative anxiety level on admission day of undergoing surgery: As mobile-based mindfulness intervention will be exercised by patients at home since last attendance to PAS session until the operation day (primary study endpoint). On the day of operation before patient being sent to the operation theatre (T1), patients will be asked to fill in the State-Trait Anxiety Inventory-State (STAI-S) questionnaire to document the level of anxiety. The score ranged from 20 to 80 with higher scores indicated higher level of anxiety.
Postoperative pain level
Patients undergoing surgery commonly experience pain after surgery and it may lead to a poor outcome. Study reported that 86% patients experienced pain after surgery and 75% had moderate to extreme pain during the immediate post-surgical period, with 74% still experienced pain after discharge. Mindfulness based intervention was also being reported to be an effective non-pharmacological technique in dealing with pain. Therefore, level of pain will be set as one of the secondary outcomes in this study. Pain intensity will be measured by a 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain given that PI-NRS is a widely used and validated instrument to measure clinical pain. Patients' pain level will be assessed before the surgery (T1); and immediately after surgery (T2).
Postoperative use of analgesics
In view of majority of patients experience pain after surgery, pain killer may be administrated during hospitalization. The frequency, choice of analgesics being used, dosage being given to patients for postoperative pain control will be retrieved and reviewed in the In-patient Medication Order Entry (IPMOE) record after patients discharged.
Number of times of revisiting emergency department after discharge
Limited studies have reported the relationship of the providence of anxiety reduction programme before surgery and the number of times of revisiting emergency department after discharge. Thus, number of times of revisiting emergency department due to post-operation related issues 1 month after discharge will be set as the secondary outcome to explore their correlation.
User Satisfaction
User satisfaction survey will be administered to the intervention group patients before they are being discharged so as to document their satisfaction level on using the mobile-based mindfulness intervention and to explore the feasibility of applying it in clinical setting in the future.
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