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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mackay Memorial Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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