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Coronary Artery Bypass Graft Surgery PatientsNCT06631846

Music Therapy and Mindfulness Meditation

A study testing Music therapy, Mindfulness meditation and Music therapy and mindfulness meditation in people with Coronary Artery Bypass Graft Surgery Patients, run by Universiti Tunku Abdul Rahman.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Music therapy, Mindfulness meditation and Music therapy and mindfulness meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2025to Mar 2026
Phase
Interventional

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

About this study

Official title: Efficacy of Music Therapy and Mindfulness Meditation on Hemodynamic Variables and Mental Health Among Coronary Artery Bypass Graft Patients

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.

Read the detailed description

Coronary artery bypass graft surgery (CABG) is an invasive procedure to treat coronary artery disease (CAD). The blocked section of the coronary artery is bypassed by using a healthy blood vessel or graft elsewhere from our body allowing the blood flow to be restored to heart. After CABG surgery, these patients encounter the problems of hemodynamic instability such as high blood pressure (BP) and low heart rate variability (HRV).

There are multiple reasons why BP increases, including pain, stress, and withdrawal of BP medications, which patient was receiving preoperatively. Typically, the BP progressively increases within 24 hours, postoperatively, and daytime systolic and diastolic BP may remain elevated for 14 weeks after CABG. In addition, nocturnal BP dipping returns to normal progressively but incompletely 14 weeks after CABG. HRV is found to lower after the CABG surgery, and it might take 6 months for the HRV to recover. The percentage of HRV after 7 days of CABG surgery was found to be 51.8%, 19.6% after 3 months, and 12.7% after 6 months.

Patients in the post-operative phase also suffer from anxiety and depression due to fear of death, pain, confusion, and sleeping disorders that can lead to poor functional mobility and quality of life. If anxiety and depression is not addressed in these patients, it could lead to major adverse cardiovascular and cerebrovascular events like myocardial infarction and stroke.

Anxiety, depression, and stress have been shown to increase the production of inflammatory cytokines such as interleukin-6 (IL-6), and elevation of C-reactive protein (CRP). Both IL-6 and CRP can affect vascular tone by promoting the production of endothelin-1 and impairing the production of nitric oxide, a potent vasodilator which will lead to hemodynamic instability by causing vasoconstriction and reduced cardiac output. The cytokines can activate the coagulation system by increasing the expression of tissue factor and reducing the production of anticoagulant factors such as thrombomodulin. Furthermore, stress can also lead to increased sympathetic nervous system activity, which can further exacerbate the effects of IL-6 and CRP on hemodynamic instability. Sympathetic activation can cause vasoconstriction and increase heart rate and contractility, leading to increased myocardial oxygen demand and reduced coronary perfusion.

The hypothalamic-pituitary-adrenal (HPA) axis and the sympathetic-adrenomedullary pathways (SAP) which activate the sympathetic nervous system, are major stress response systems in the body that regulate the release of cortisol, and stress hormones. These hormones can impair fibrinolysis by reducing the production of plasminogen activators and increasing the production of plasminogen activator inhibitors, leading to an increase in heart rate, blood pressure, and cardiac output. These changes can contribute to hemodynamic instability after CABG surgery. A study found that patients with post-traumatic stress disorder had higher levels of cortisol and plasminogen activator inhibitor-1 compared to controls, suggesting a link between stress, and altered fibrinolysis. A reviews based on various epidemiological studies and clinical trials investigated the association between stress and thrombosis and study concluded that acute and chronic stress can increase the risk of thrombosis, including activation of the sympathetic nervous system, increased platelet activation, and alterations in blood coagulation and fibrinolysis, which may further lead to an increased risk of hemodynamic instability after CABG surgery. Dysregulation of the HPA axis and SAP have been implicated in the development and progression of coronary artery disease (CAD). In addition, dysregulation of both these systems can contribute to a state of chronic stress in depressed individuals, which can have negative effects on physical and mental health and increase the risk of developing cardiovascular disease, as well as worsen the symptoms of depression and anxiety.

A study showed that 30% to 40% of post CABG surgery patients experience psychological disorder like depression and anxiety which increase the rate of morbidity even after years of discharge. A meta-analysis found that nearly one-third of CABG patients were depressed before surgery and their symptoms significantly improved after the surgery. However, the study also indicated that approximately one-fifth of those who undergo CABG remain depressed or develop new depression. A 2-year prospective follow-up study found that post-CABG patients suffered from chronic depression and had a significantly higher incidence of cardiac events and hospitalization rates compared to patients without depressive symptoms. Therefore, it is important to address these issues in patients after CABG surgery, which would potentially influence the outcomes of the hemodynamic variables. Non-pharmacological intervention like music therapy (MT), and mindfulness meditation (MM) have been successfully used to manage anxiety and depression among patients with different surgeries in post-operative phase.

There have been many studies conducted to explore the potential benefits of MT in reducing stress and anxiety during surgery and decreasing the need for anaesthesia focused on patients undergoing elective orthopaedic surgery and effect of MT on open-hernia surgery. Both these studies aimed to assess the stress levels and anaesthetic drug requirements of patients before and after MT intervention. Authors provided valuable insights for developing effective intervention that can assist patients in managing stress and anxiety associated with surgery, and potentially decrease their reliance on anaesthesia. Furthermore, compared to the control group, individuals who listened to music for 30-minutes shows increased levels of oxytocin.

A recent systematic review found that music not only affects the patients' emotional and psychological well-being via the autonomic nervous system (ANS), but it can also have a potential impact on cardiovascular variables, including HRV, heart rate (HR), respiration rate (RR), and BP. Research has established that HRV is a biomarker that reflects the activity of the ANS. Therefore, MT can be a promising intervention tool to regulate both HRV and ANS.

MM originated from Buddhism and has been practiced for over 2550 years. In early 1960s, it was introduced to the Western psychology and healthcare sectors. This non-pharmacological intervention has since evolved and been extensively reviewed, with findings indicating that it has a significantly positive impact on psychological health. Specifically, it has been found to reduce symptoms of anxiety, depression, rumination, psychological distress, cognitive disorganization, post-traumatic avoidance symptoms, and medical symptoms. It also increases the positive sense of spirituality, empathy, sense of cohesion, and self-compassion, and improve quality of life, satisfaction of life in clinical and non-clinically patients with psychosocial and existential distress.

According to Kabat-Zinn, mindfulness-based stress reduction could significantly reduce BP in patients with coronary heart disease by an average of 8 mmHg after only 8-weeks of treatment. Similarly, a study found that 4-weeks of mindfulness-based cognitive therapy resulted in improved symptoms for patients with chronic heart failure. The effects of an 8-week MM program on inflammatory markers were examined in healthy adults. The study found that the MM group had lower levels of the inflammatory marker IL-6 compared to a control group. This highlights the potential benefits of mindfulness-based intervention for improving health outcomes by reducing inflammatory markers.

Another study investigated the effect of MM on immunological function in women diagnosed with breast cancer. Researchers discovered significant improvements in women's immune function, with lower levels of pro inflammatory cytokines and decreased production of IL-6, compared to the active control group. Additionally, notable enhancements in patients' psychological well-being, including reduced levels of anxiety, depression, and stress was noticed.

A recent meta-analysis on MM reported significantly decrease cortisol levels in patients at risk of various health problems, such as cardiovascular disease, depression, and anxiety. Furthermore, the use of MM intervention was found to have a beneficial impact on the HRV, which is a primary time domain measure for vagal tone.

In conclusion, both MT and MM have been found to induce changes in the prefrontal cortex region of the brain. Specifically, these changes are observed in the limbic pathway, which is highly responsive to human behaviour and emotional changes, and plays an important role in the regulation of ANS. Additionally, both interventions positively influence the cardiac autonomic system and hemodynamic variables through the stimulation of the vagus nerve, which has been shown to have direct advantages in managing cardiovascular health by reducing anxiety and depression.

At present, exercise-based cardiac rehabilitation is the single recommended secondary prevention strategy for cardiac patients that aims to address anxiety and psychosocial wellbeing, and there is a critical gap to address psychosocial needs of cardiac patients, particularly in CABG patients. Poor mental health and associated negative emotions can create significant challenges and barriers for patients in making and sustaining important behavioral and lifestyle modifications. Although MT and MM individually are reported to be effective in managing the psychological problems such as anxiety and depression, but there is scarcity in the current literature with regards to investigating the cumulative and combined effect of these 2 interventions. Therefore, this study aims to bridge this gap and develop an interventional protocol that can address and improve the mental health and overall quality of life of these patients.

Being tested
Music therapy, Mindfulness meditation, Music therapy and mindfulness meditation, Cardiac rehabilitation
Keywords
Coronary Artery Bypass Graft Patients, Hemodynamic Variables, Mental Health, Music Therapy, Mindfulness Meditation, Anxiety, Depression, Quality of life
Medical subject headings
Psychological Well-Being, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music therapyOther

    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.

  • Mindfulness meditationOther

    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.

  • Music therapy and mindfulness meditationOther

    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.

  • Cardiac rehabilitationOther

    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.

Study groups in NCT06631846
Study groupRoleWhat they receive
Music therapyExperimentalNot described
Receives: Other: Music therapy
Mindfulness meditationExperimentalNot described
Receives: Other: Mindfulness meditation
Combination of music therapy and mindfulness meditationExperimentalNot described
Receives: Other: Music therapy and mindfulness meditation
Conventional phase-1 cardaic rehabilitationActive comparatorNot described
Receives: Other: Cardiac rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

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

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

  4. 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.

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

  5. 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.

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

Secondary outcomes (1)
  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study startJul 2025 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Why it stopped: The study was terminated due to administrative and operational considerations.

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06631846
Sponsor's protocol ID
Music Therapy and Mindfulness
Status last verified
May 2026
First submitted
4 Oct 2024
Last updated
19 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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