Coronary Heart DiseaseNCT06637969
Mindfulness-based Interventions on Psychophysiological Recovery and Physical Functioning After Coronary Heart Surgery
A study testing mindfulness-based in people with Coronary Heart Disease and Mindfulness, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Mindfulness, Recovery, Psychological
- What is being tested?
- mindfulness-based
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Oct 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taiwan Presbyterian Church Mackay Medical Foundation Mackay Memorial Hospital
Taipei, 104217
About this study
Official title: 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,
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.
- Being tested
- mindfulness-based
- Keywords
- coronary heart disease surgery, mindfulness
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-basedBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| mindfulness-based | Experimental | 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 Receives: Behavioral: mindfulness-based |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (3)
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.
Measured: one year
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.
Measured: one year
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Oct 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637969
- Sponsor's protocol ID
- D528
- Status last verified
- Feb 2025
- First submitted
- 23 Aug 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness-based Interventions on Psychophysiological Recovery and Physical Functioning in Patients After Coronary Heart Surgery
- ClinicalTrials.gov ID
- NCT06637969
- Acronym / sponsor ID
- D528
- Keywords
- coronary heart disease surgery, mindfulness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based | Experimental | Behavioral: mindfulness-basedThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness-basedThe 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 | Behavioural | mindfulness-based |
Primary outcome
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.
3 secondary outcomes
Incentive Spirometer
Time frame: one year
Verran and Snyder Halpen Sleep scale
Time frame: one year
Hospital Anxiety and Depression Scale
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based in people with Coronary Heart Disease and Mindfulness, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional assessment of interoceptive awareness (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.