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

NCT07005973 | Recruiting

• 1 other identifier: CIRB-2025-146-3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mobile-based mindfulness; pre-operative anxiety; post-operative pain; postoperative use of analgesics

Outcome Measures

Primary Outcomes (1)

• Pre-operative anxiety level

  Pre-operative anxiety level on admission day of undergoing surgery: As mobile-based mindfulness intervention will be exercised by patients at home since last attendance to PAS session until the operation day (primary study endpoint). On the day of operation before patient being sent to the operation theatre (T1), patients will be asked to fill in the State-Trait Anxiety Inventory-State (STAI-S) questionnaire to document the level of anxiety. The score ranged from 20 to 80 with higher scores indicated higher level of anxiety.

  From enrollment to the day of admission for surgery (at least 4 weeks)

Secondary Outcomes (4)

• Postoperative pain level

  From the day of admission to the day of discharge after surgery

• Postoperative use of analgesics

  From post-operation to the day of discharge

• Number of times of revisiting emergency department after discharge

  From the day of discharge to 1 month after surgery

• User Satisfaction

  From enrollment to the day of discharge after surgery

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention group

EXPERIMENTAL

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.

Behavioral: mobile-based mindfulness intervention

Interventions

mobile-based mindfulness intervention BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead

Study Sites (1)

Tin Shui Wai Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• KIT HANG MR KWAN, Advanced Practice Nurse

  Tin Shui Wai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KIT HANG MR KWAN, Advanced Practice Nurse

CONTACT

825-98639969; kkh338@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advanced Practice Nurse

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 5, 2025
• Study Start: June 13, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

HK (1)