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

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Trial completed Show 8 more changesShow less
    • Final enrollment: 46 participants (planned 40)
    • Study completion date changed from estimate of Dec 31, 2026 to Feb 28, 2026
    • Primary completion date changed from estimate of Dec 31, 2025 to Jan 18, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 25 of 29 entries
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Jun 10, 2025 to Jun 13, 2025
    • Site details revised
    • Publications: details revised at 29 of 29 entries
    • Eligibility criteria shortened, about 5 words
  3. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07005973
Lead Sponsor Hospital Authority, Hong Kong
Conditions
(from sponsor)
Mobile-based Mindfulness Intervention to Reduce Preoperative Anxiety, Pre-operative Anxiety, Postoperative Pain, Postoperative Use of Analgesics
Related terms Postoperative Pain
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov