Clinical trial NCT07005973: Effects of Mobile-based Mindfulness Intervention to Reduce Preoperative Anxiety for Patients Undergoing Elective Surgery
Official title: Effects of Mobile-based Mindfulness Intervention to Reduce Preoperative Anxiety for Patients Undergoing Elective Surgery: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2025-06-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

This RCT study will be conducted in Tin Shui Wai Hospital. Approval and endorsement have been granted from Chief of Service (COS) of surgery department. The research proposal will be submitted to Hospital Authority Central Institutional Review Board (IRB) for ethical approval, and then it will be pre-registered in research registry at clinicaltrials.gov.

Patients with evidence of anxiety and meeting the inclusion criteria will be recruited to the trial directly during they attend the Pre-anaesthesia Assessment Service (PAS) in day ward of Tin Shui Wai Hospital.

Level of anxiety will be assessed through the State-Trait Anxiety Inventory Form Y (STAI-Y) which is divided into the measurement of state and trait anxiety. The original STAI was developed in 1970 and has been translated to more than 30 languages for cross-cultural research and clinical practice. STAI-Y has been proven that it is an appropriate and adequate instrument for anxiety related study in both research and clinical settings in accordance to various reliability and validity tests.

The STAI-Y is a 4-point Likert self-reported scale consisting of a total of 40 items, which are divided into two subscales: trait anxiety (STAI-T) and state anxiety (STAI-S), each containing 20 items. STAI-T is used to determine a person's underlying personality anxiety level as trait anxiety is a more stable tendency to react to stress with anxiety which reflecting the underlying part of a person's personality; while STAI-S is used to determine a person's current anxiety level as state anxiety is a temporary emotional state involving feelings of tension that can fluctuate in intensity and usually appears in preoperative patients. The STAI-All items are followed by a 4-point scale rating the frequency of feelings from "not at all" to "very much", and scoring from 1 to 4 each. The subtotal score ranged from 20 to 80 with higher scores indicated higher level of anxiety. A cut-off point of 39-40 has been suggested for detection of clinically relevant symptoms for the state anxiety scale. A validated Chinese version of STAI-Y questionnaire will be adapted in this study.

Patients' anxiety level will be assessed at 2 different time-points: baseline assessment will be conducted on the day of patients attending PAS clinic (T0); post treatment assessment on the day of admission before patients being sent to operation theater (T1).

All patients attend the PAS clinic will be initially distributed the STAI-T questionnaire to fill in to detect subjects with potential underlying anxiety. A cutoff score of 40 is commonly used to define probable clinical levels of anxiety, therefore, patients with score 40 or above showed in questionnaire of STAI-T will be invited to participate in this clinical trial.

Research investigator will explain the details of the trial and answer all the questions raised by patients. These patients are then presented with the written information of the trial. Each participant will receive a written informed consent. As all patients' participation are on voluntary basis, they could withdraw from the study at any time without penalty during the trial.

Patients will be randomly allocated (1:1) into 2 groups: intervention group or control group.

For 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.

For intervention group, patients will be taught to exercise mindfulness on top of receiving usual care as control group. This group of patients will be helped to install a mobile app on mindfulness developed by the University of Hong Kong which is originally being used for the promotion of mental health among students and teachers in Hong Kong. The mobile app is now opened to the public and no pre-registration is required for using the app. The mobile app provides a platform with video and audio-guided soundtracks which includes body scan, mindful breathing, eating, stretching and natural sounds for public to practice mindfulness at home. Upon the recruitment, patients will be educated to use the app regularly at home until their scheduled surgery appointment. Interval phone follow up will be provided for the intervention group patients on the use of the mindfulness mobile app to ensure the compliance to the intervention and also to tackle with the difficulties they may encounter during the interventional period.

Eligibility criteria: 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
* no previous experience of surgery
* 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

Primary outcomes:
measure: Pre-operative anxiety level
timeFrame: From enrollment to the day of admission for surgery (at least 4 weeks)
Secondary outcomes:
measure: Postoperative pain level
timeFrame: From the day of admission to the day of discharge after surgery
measure: Postoperative use of analgesics
timeFrame: From post-operation to the day of discharge
measure: Number of times of revisiting emergency department after discharge
timeFrame: From the day of discharge to 1 month after surgery
measure: User Satisfaction
timeFrame: From enrollment to the day of discharge after surgery
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Tin Shui Wai Hospital
Study officials:
affiliation: Tin Shui Wai Hospital
name: KIT HANG MR KWAN, Advanced Practice Nurse
role: PRINCIPAL_INVESTIGATOR
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