- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06637969
Mindfulness-based Interventions on Psychophysiological Recovery and Physical Functioning After Coronary Heart Surgery
February 12, 2025 updated by: Mackay Memorial Hospital
Effects of Mindfulness-based Interventions on Psychophysiological Recovery and Physical Functioning in Patients After Coronary Heart Surgery
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,
Study Overview
Status
Active, not recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 104217
- Taiwan Presbyterian Church Mackay Medical Foundation Mackay Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multidimensional assessment of interoceptive awareness
Time Frame: one year
|
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.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incentive Spirometer
Time Frame: one year
|
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.
|
one year
|
|
Verran and Snyder Halpen Sleep scale
Time Frame: one year
|
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.
|
one year
|
|
Hospital Anxiety and Depression Scale
Time Frame: one year
|
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.
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2023
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
August 23, 2024
First Submitted That Met QC Criteria
October 9, 2024
First Posted (Actual)
October 15, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 12, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D528
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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