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

NCT07005973 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-11

No results posted yet for this study

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.

Conditions

  • Mobile-based Mindfulness Intervention to Reduce Preoperative Anxiety
  • Pre-operative Anxiety
  • Postoperative Pain
  • Postoperative Use of Analgesics

Interventions

BEHAVIORAL

mobile-based mindfulness intervention

Patients 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.

Sponsors & Collaborators

  • Hospital Authority, Hong Kong

    lead OTHER_GOV

Principal Investigators

  • KIT HANG MR KWAN, Advanced Practice Nurse · Tin Shui Wai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-13
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07005973 on ClinicalTrials.gov