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

Recruiting · NCT07005973 · Interventional (participants receive a specific treatment)

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Interventions studied

mobile-based mindfulness intervention

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

Yes - healthy volunteers may be accepted

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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

Exclusion criteria

unable to provide informed consent
history or current treatment for psychological complaints
serious physical or psychological co-morbidities
hearing or vision impairment
patients withdrawal from continuing to participate in the study

Where it is running

1 location listed.

Tin Shui Wai Hospital - Hong Kong, Hong Kong

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →