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Clinical Trials/NCT07005973
NCT07005973RecruitingNot Applicable

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

Hospital Authority, Hong Kong1 site in 1 country40 target enrollmentStarted: June 13, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Pre-operative anxiety level

Study Overview

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.

Detailed Description

Preoperative anxiety is a common phenomenon being reported in 60-80% of patients who are undergoing a surgical procedure and it was shown to be associated with negative postoperative outcomes such as suboptimal pain control, sleep disturbances, delayed wound healing, prolonged length of hospitalization and dissatisfying patients' hospitalization experience as a result. The current practice being adopted to minimize the level of anxiety in preoperative patients includes pharmacological and non-pharmacological approach. Pharmacological interventions include sedative and anti-anxiety drugs can be used before an operation to improve patient's emotion, however, studies have shown that adverse reactions on respiratory and central nervous system may be encountered, leading to a negative outcome of the operation. On the other hand, non-pharmacological interventions such as spiritual support, hypnosis, acupuncture, interview, cognitive behaviour therapy (CBT) and meditation are shown to be an effective strategy to alleviate the preoperative anxiety by anesthesiologists.

Mindfulness is a meditation concept originally introduced from India and has been developed into a structured approach for stress reduction treatment, nowadays commonly being adapted in both clinical and non-clinical setting. Mindfulness-based interventions (MBIs) have demonstrated efficacy in improving various clinical outcomes especially in reducing stress and anxiety. Mindfulness-based stress reduction (MBSR) program is a well-known MBI widely being used in various clinical conditions include the management on chronic pain, cancer, vascular disease and preoperative anxiety. However, traditional MBIs programs are extensive and required face-to-face training conducted by a well-trained qualified instructor. The standard MBSR program is intensive, consists of a 2.5 hours weekly group-based face-to-face classes lasting for 8 weeks plus a one full day retreat at the end of the program. Taking into consideration of the long duration and a certified instructor are required for the standard MBSR training program, delivery of mobile-based mindfulness interventions via the mobile app was introduced as an alternative platform to practice mindfulness making it feasible, accessible, acceptable and inexpensive in reducing psychological distress.

According to the systematic review, positive impact of mobile-based mindfulness interventions with the enhancement on mental health treatment was found and mobile-based mindfulness interventions were also found to be promising as an adjunct intervention only to improve mindfulness skills and depressive symptoms. In view of the inconsistency of clinical outcomes on mobile-based mindfulness interventions among systematic reviews, a randomized controlled trial to examine the effectiveness of mobile-based mindfulness interventions for reduction of preoperative anxiety need to be studied in local context. Furthermore, the effects of mobile-based mindfulness interventions on preoperative anxiety have been understudied in Chinese population and the recent systematic review has not identified in any Chinese study.

The aim of study is to examine the effects of mobile-based mindfulness intervention to reduce preoperative anxiety for patients undergoing elective surgery. We hypothesize that compared to standard care group, delivery of mobile-based mindfulness intervention can reduce preoperative anxiety for patients undergoing elective surgery.

A parallel-arm (mobile-based mindfulness intervention vs. usual care [active control]) randomized controlled trial (RCT) will be adapted in this study as RCT is the best study design to control for confounders.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: mobile-based mindfulness intervention (Behavioral)

Outcomes

Primary Outcomes

Pre-operative anxiety level

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

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor
Hospital Authority, Hong Kong
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

KWAN KIT HANG

Advanced Practice Nurse

Hospital Authority, Hong Kong

Study Sites (1)

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