NCT06637969

Brief 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,

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

August 23, 2024

Last Update Submit

February 12, 2025

Conditions

Keywords

coronary heart disease surgery, mindfulness

Outcome Measures

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.

    one year

Secondary Outcomes (3)

  • Incentive Spirometer

    one year

  • Verran and Snyder Halpen Sleep scale

    one year

  • Hospital Anxiety and Depression Scale

    one year

Study Arms (1)

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

Behavioral: mindfulness-based

Interventions

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

mindfulness-based

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taiwan Presbyterian Church Mackay Medical Foundation Mackay Memorial Hospital

Taipei, 104217, Taiwan

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2024

First Posted

October 15, 2024

Study Start

October 15, 2023

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations