Music Therapy and Mindfulness Meditation

NCT06631846 | Not Yet Recruiting DMC

• 1 other identifier: Music Therapy and Mindfulness
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

Coronary artery bypass graft surgery (CABG) involves bypassing a blocked artery with a healthy blood vessel elsewhere from body allowing the blood flow to be restored to heart. Most patients after CABG surgery have hemodynamic instability such as elevated blood pressure (BP) and low heart rate variability (HRV). High BP could be due pain, stress, and withdrawal of BP medications, which patient used to take preoperatively. BP progressively increases within 24 hours, postoperatively, and daytime systolic and diastolic BP may remain elevated for =14 weeks after CABG, while lower HRV may take 6 months to recover after CABG. In addition, these patients suffer from anxiety and depression which is associated with poor mental health that can create significant challenges and barriers for patients in making and sustaining important behavioral and lifestyle modifications. Non-pharmacological interventions such as music therapy (MT) and mindfulness meditation (MM) have been successfully used to manage anxiety and depression among patients undergone various surgeries, but there is scarcity in the current literature with regards to investigating the combined effect of MT and MM on anxiety and depression in CABG patients. Furthermore, the cumulative effect of these 2 interventions on hemodynamic variables is not well established. Therefore, this study aims to bridge these gaps and develop an interventional protocol that can improve the hemodynamic stability and mental health of CABG patients.

Conditions

Coronary Artery Bypass Graft Surgery Patients

Keywords

Coronary Artery Bypass Graft Patients; Hemodynamic Variables; Mental Health; Music Therapy; Mindfulness Meditation; Anxiety; Depression; Quality of life

Outcome Measures

Primary Outcomes (5)

• Systolic blood pressure will be measured using a calibrated digital BP measuring monitor among 48 participants after CABG.

  At baseline before beggining intervention and post-intervention at the end of1-week.

• Diastolic blood pressure will be measured using a calibrated digital BP measuring monitor among 48 participants after CABG.

  At baseline before beggining intervention and post-intervention at the end of 1-week.

• Heart rate variability will be measured using a standard portable 12 lead ECG machine among 48 participants after CABG.

  At baseline before beggining intervention and post-intervention at the end of 1-week.

• Anxiety will be measured utilizing Beck Anxiety Inventory (BAI), which consists of 21 self-reported items to assess the intensity of physical and cognitive anxiety symptoms during the past week among 48 participants after CABG.

  At baseline before beggining intervention and post-intervention at the end of 1-week.

• Depression will be measured utilizing Beck Depression Inventory (BDI), which consists of 21 self-reported items to assess the characteristic attitudes and symptoms of depression during the past week among 48 participants after CABG.

  At baseline before beggining intervention and post-intervention at the end of 1-week.

Secondary Outcomes (1)

• Quality of life will be measured using Short Form 12 Health Survey (SF-12), which consisted of 12 short from items measuring the extent to which physical or emotional problems interfere with social activities among 48 participants after CABG.

  At baseline before beggining intervention and post-intervention at the end of 1-week.

Study Arms (4)

Music therapy

EXPERIMENTAL

Other: Music therapy

Mindfulness meditation

EXPERIMENTAL

Other: Mindfulness meditation

Combination of music therapy and mindfulness meditation

EXPERIMENTAL

Other: Music therapy and mindfulness meditation

Conventional phase-1 cardaic rehabilitation

ACTIVE COMPARATOR

Other: Cardiac rehabilitation

Interventions

Music therapy OTHER

Participants in the music therapy group (MTG) will be comfortably lying on the bed in a reclined position of 30-45 degrees. Using a headphone, participants will be instructed to select a volume that is comfortable to their ears and listen to the music titled as "The Best Relaxing Piano and Flute Music Ever" which will be played for 30-minutes every day for 1-week. Patients will be encouraged to focus on the music and let it fill their senses.

Music therapy

Mindfulness meditation OTHER

Mindfulness meditation group (MGT)will be listening to audio of Guided Mindfulness Meditation Series 1 by Jon Kabat-Zinn. Similar to MTG, participants in MMG will be lying on the bed in a reclined position of 30-45 degrees. A headphone to listen to the audio of guided MM will be provided to all the participants. Participants will begin with relaxation technique by focusing on deep breathing to help calm their body and mind. This will be followed by focusing on the present moment, letting go of any thoughts or distractions that come up. Participants can focus on their breath, bodily sensations, or a specific object in their environment. Finally, the session will end by expressing a gratitude for their body and mind and setting an intention to carry the feelings of relaxation and mindfulness with them throughout the day. Similar to MTG, MMG will engage in 30-minutes of MM every day for 1-week.

Mindfulness meditation

Music therapy and mindfulness meditation OTHER

Music therapy and mindfulness meditation group will be receiving both music therapy and mindfulness meditation in the same body position as MTG and MMG. Firstly, participants will listen to MT for 30-minutes followed by MM for another 30-minutes. In between the 2 interventions, a 15-minute of break will be provided to all participants. Intervention will be carried out every day for 1-week.

Combination of music therapy and mindfulness meditation

Cardiac rehabilitation OTHER

Control Group will not receive any other therapy except the conventional post-operative cardiac rehabilitation. Other 3 intervention groups will also be participating in the usual cardiac rehabilitation program. Cardiac rehabilitation will be conducted during phase I, where rehabilitation will focus on early mobilization and ambulation of participants with a target heart rate of resting heart rate + 30 beats, with the non-strenuous exercises in the bed or at the bedside, focusing on a range of motion and limiting hospital deconditioning.

Conventional phase-1 cardaic rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both gender of age 18 and above
• Undergone isolated CABG
• Ejection fraction ≥ 50%
• Hemodynamically stable
• Willing to participate in this study

You may not qualify if:

• Participants with atrial fibrillation
• Hearing abnormalities
• Cardiovascular diseases other than coronary artery disease, respiratory diseases, and any neurological/musculoskeletal problems that will restrict eligible participants to participate in the study.

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead

MeSH Terms

Conditions

Psychological Well-Being; Anxiety Disorders; Depression

Interventions

Music Therapy; Mindfulness; Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Mental Disorders; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Behavior Therapy; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Imtiyaz Ali Mir

CONTACT

+60108040342; imtiyaz2204@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share