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Active, not recruitingNCT06637969Updated Feb 14, 2025

Mindfulness-based Interventions on Psychophysiological Recovery and Physical Functioning After Coronary Heart Surgery

An interventional study of mindfulness-based in Coronary Heart Disease, Mindfulness and Recovery, Psychological, sponsored by Mackay Memorial Hospital. Active, not recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-14.

Sponsored by Mackay Memorial Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
  • Registered 10 months after the study started (first participant enrolled Oct 2023, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to explore the effect of mindfulness on the physical and mental recovery and physical function of patients after coronary heart surgery. Methods: Convenience sampling was adopted, and patients in the cardiology ward of a northern medical center were selected as the research subjects. Eligible subjects were assigned to the experimental group (mindfulness treatment) and the routine care group. The subjects were tested on the day before surgery and on the seventh day after intervention. Physical and mental recovery (awareness of inner feelings, anxiety, depression, sleep quality, pain) and physical function (vital capacity, cardiorespiratory endurance, dyspnea after exercise) were measured,

Read the detailed description

Background: If patients with coronary heart disease are not properly controlled and treated, it is not only easy for the disease to relapse and cause angina pectoris, which will prevent the heart from receiving sufficient blood and oxygen supply, leading to an increase in the severity of the disease, and may lead to coronary artery bypass surgery, but postoperative complications may occur. Due to reduced respiratory muscle vitality, chest wound pain caused by median sternotomy surgery, and bed rest, resulting in incomplete lung expansion or lung collapse, discomfort due to physiological symptoms, and fear of life-threatening disease, and the risk of disease The uncertainty of treatment causes patients to have negative emotions of anxiety and depression, affecting their sleep quality. Purpose: The purpose of this study is to explore the effect of mindfulness on the physical and mental recovery and physical function of patients after coronary heart surgery. Methods: Convenience sampling was adopted, and patients in the cardiology ward of a northern medical center were selected as the research subjects. Eligible subjects were assigned to the experimental group (mindfulness treatment) and the routine care group. The subjects were tested on the day before surgery and on the seventh day after intervention. Physical and mental recovery (awareness of inner feelings, anxiety, depression, sleep quality, pain) and physical function (vital capacity, cardiorespiratory endurance, dyspnea after exercise) were measured, and the secondary measurement data were statistically analyzed using SPSS 29.0 for Windows software suite. Compare the differences between the two groups in physical and mental recovery and physical function.

02

Conditions studied

  • Coronary Heart Disease
  • Mindfulness
  • Recovery, Psychological
  • Physical Functioning

Keywords

  • coronary heart disease surgery, mindfulness
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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 64 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Mackay Memorial Hospital is the lead sponsor of 118 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria 18Aged Patients who are hospitalized and expected to undergo coronary artery bypass surgery Those who can cooperate with regular use of induction spirometry Exclusion Criteria major mental illnesses cognitive impairment long-term bed rest mobility difficulties have deformities of the mouth

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    mindfulness-based

    The experimental group was also provided with a total of 30 minutes of mindfulness training once a day for seven consecutive days. The content included mindful breathing awareness for 8 minutes while resting and lying in bed, 10 minutes of mindfulness meditation, 12 minutes of mindfulness body scanning, and 10 minutes of mindful walking and breathing. The control group The group received routine care, and a pre-test was conducted before the implementation of the interventional measures (from 7 pm to 9 pm the day before the operation), and a post-test was conducted after the seven-day intervention (from 7 pm to 9 pm on the seventh day of the interventional treatment). Comparison between the experimental group and the control group group differences

    Behavioral: mindfulness-based

Interventions

  • Behavioralmindfulness-based

    The experimental group was also provided with a total of 30 minutes of mindfulness training once a day for seven consecutive days. The content included mindful breathing awareness for 8 minutes while resting and lying in bed, 10 minutes of mindfulness meditation, 12 minutes of mindfulness body scanning, and 10 minutes of mindful walking and breathing. The control group The group received routine care, and a pre-test was conducted before the implementation of the interventional measures (from 7 pm to 9 pm the day before the operation), and a post-test was conducted after the seven-day intervention (from 7 pm to 9 pm on the seventh day of the interventional treatment). Comparison between the experimental group and the control group group differences

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What researchers measure

Primary outcomes

  1. Multidimensional assessment of interoceptive awareness

    The inner feeling awareness scale covers eight factors: attention, non-distraction, non-worry, concentration adjustment, emotional awareness, self-regulation, body listening, and trust, with a total of 32 questions. The questionnaire is scored on a scale of 0-5 based on the response content, with higher scores indicating more positive inner feeling awareness.

    Time frame: one year

Secondary outcomes

  1. Incentive Spirometer

    When the first ball is sucked up and reaches the top for one second, the lung ventilation volume is 600ml/second. When the second ball is sucked up and reaches the top, the lung ventilation volume is 900ml/second. When starting and reaching the peak, the lung ventilation volume is 1200ml/second.

    Time frame: one year

  2. Verran and Snyder Halpen Sleep scale

    The sleep quality referred to in this study uses the Chinese version of the Weixin Sleep Scale compiled by Lin Xiaoling and Cai Xinling to evaluate the subjective feelings of sleep last night (from 10 clock last night to 8 clock in the morning). Its content covers sleep disturbance, sleep effectiveness and sleep supplementation There are three factors, a total of 15 questions. The questionnaire is scored on a scale of 0-100 according to the answer content. The minimum score for each positive question is 0 points and the maximum score is 100 points. The total score is 0-1500 points. The higher the score, the better the sleep quality.

    Time frame: one year

  3. Hospital Anxiety and Depression Scale

    This scale was developed by Zigmond and Snaith in 1983 to measure patients; anxiety and depression. It has 14 questions in total. The higher the score, the higher the degree of anxiety or depression. The odd-numbered questions assess anxiety, and the even-numbered questions assess depression. A score of 0-7 indicates no anxiety or depression, a score of 8-10 indicates a borderline case, and a score of 11-21 indicates anxiety or depression.

    Time frame: one year

07

Study locations

1 site
  • Taiwan Presbyterian Church Mackay Medical Foundation Mackay Memorial Hospital
    Taipei, 104217, Taiwan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06637969
Lead sponsor
Mackay Memorial Hospital
Responsible party
Sponsor
First posted
Oct 15, 2024
Start date
Oct 15, 2023
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Feb 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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