Effects of Mobile-based Mindfulness Intervention to Reduce Preoperative Anxiety for Patients Undergoing Elective Surgery: A Pilot Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

• STAI-T score \>=40

Locations
Other Locations
Hong Kong Special Administrative Region
Tin Shui Wai Hospital
RECRUITING
Hong Kong
Contact Information
Primary
KIT HANG MR KWAN, Advanced Practice Nurse
kkh338@ha.org.hk
825-98639969
Time Frame
Start Date: 2025-06-13
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 40
Treatments
No_intervention: Control group
Patients will receive usual care from surgeon, anesthetist and perioperative team including the delivery of operation related information, environment of operating theatre, the process of anesthesia, postoperative care from recovery room to discharge, etc.
Experimental: Intervention group
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.
Related Therapeutic Areas
Sponsors
Leads: Hospital Authority, Hong Kong

This content was sourced from clinicaltrials.gov