Clinical Trial

Effects of Mobile-based Mindfulness Intervention to Reduce Preoperative Anxiety for Patients Undergoing Elective Surgery

Recruiting
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Record status
This record was last updated September 11, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-28.
Status change: Not Yet Recruiting → Recruiting 2025-09-09
Trial Details
NCT Number NCT07005973
Lead Sponsor Hospital Authority, Hong Kong
Conditions Mobile-based Mindfulness Intervention to Reduce Preoperative Anxiety, Pre-operative Anxiety, Postoperative Pain, Postoperative Use of Analgesics
Enrollment 40 participants
Start Date 2025-06-13
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-11