Heart Rate Variability and Music Listening

NCT ID: NCT06929208

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2027-12-31

Brief Summary

High anxiety levels may lead to negative outcomes, and previous studies have shown that music listening could reduce periprocedural anxiety and depression. Recent evidence suggests that a lower heart rate variability (HRV) may be associated with anxiety and depression disorders, but the association of these HRV parameters with preoperative mood in the procedural settings are less defined.

In this prospective cohort pilot study, the study team will investigate the association between HRV and psychological vulnerability (anxiety, depression) in the presence of music listening before procedures. A total of 120 patients about to undergo procedures (surgery, procedures) will be recruited in three healthcare institutions in Singapore (KK Women's and Children's Hospital, Singapore General Hospital, Changi General Hospital). Patients will be asked to have their ECG readings recorded before, during, and after music listening. Preprocedural information (e.g., demographic, clinical) and psychological scores will be collected.

Detailed Description

Autonomic nervous system (ANS) comprises two opposing components: sympathetic nervous system (SNS) and parasympathetic nervous system (PNS). It is reported that alterations in the balance between SNS and PNS activity may be related to anxiety and depression. SNS and PNS activity can be non-invasively quantified using HRV, the fluctuation in time intervals between adjacent heartbeats. HRV may be obtained from ECG readings to derive the indices of the variability in time and frequency domains. A meta-analysis in patients with anxiety disorders demonstrated that HRV parameters including root mean square of successive differences (rMSSD), standard deviation, and high frequency HRV (HF-HRV, 0.15-0.4Hz) was lower as compared with healthy individuals.

Compared to the conventional use of pharmacological drugs, music listening is proven to be safer and more cost-effective, reduce perioperative pain, and improve patient satisfaction. Furthermore, music listening can modulate the patient's inflammatory response to reduce anxiety, which could help distracting patients from focusing on negative thoughts of the impending surgery, a major source of anxiety. By providing a source of serenity and calmness through music, patients can divert their attention to and focus less on feelings of anxiety and fear.

The study team therefore proposes to record HRV parameters before, during and after music listening and compare the readings against the psychological scores collected as part of the study. This would facilitate the understanding in the association between HRV and psychological aspects in surgical settings. The overall aim is to develop an individualised, targeted approach to understand the relationship between HRV and mood, and how the improvement in HRV parameters in the presence of music listening may help to improve perioperative experiences.

Conditions

Heart Rate Variability; Anxiety; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single arm for HRV and music listening

ECG recording for HRV data before, during and after music listening

Group Type: EXPERIMENTAL

Electrocardiogram (ECG) monitor

Intervention Type: DEVICE

A novel AI-based risk stratification algorithm incorporated into portable platform will be used to monitor and measure patient's ECG, blood pressure, SpO2, and HRV parameters. The platform comprises a tablet application that the clinicians interface with, and coupled with a patient monitoring device with the app that received the real-time patient vital signs to be processed. It requires only a 5-minute 12-lead ECG recording and provides a diagnostic report and risk score on major adverse cardiac events in patients with chest pain complaints. The device is approved as a Class C Medical device by Health Science Authority Singapore for clinical use in Singapore.

Three ECG samples for HRV data will be recorded before, during and after music listening, with a sampling rate of 1000Hz, 5-10-minute duration in the supine position and breathing spontaneously to minimise influence from external factors.

Music listening

Intervention Type: OTHER

Patients will be given a mobile phone to choose their preferred music to be played during surgery. The music list contains songs across pre-saved playlists spanning different music genres compiled by the institution's music therapist to ensure adequate coverage of the various music genres and to promote relaxation and serenity.

Interventions

Electrocardiogram (ECG) monitor

A novel AI-based risk stratification algorithm incorporated into portable platform will be used to monitor and measure patient's ECG, blood pressure, SpO2, and HRV parameters. The platform comprises a tablet application that the clinicians interface with, and coupled with a patient monitoring device with the app that received the real-time patient vital signs to be processed. It requires only a 5-minute 12-lead ECG recording and provides a diagnostic report and risk score on major adverse cardiac events in patients with chest pain complaints. The device is approved as a Class C Medical device by Health Science Authority Singapore for clinical use in Singapore.

Three ECG samples for HRV data will be recorded before, during and after music listening, with a sampling rate of 1000Hz, 5-10-minute duration in the supine position and breathing spontaneously to minimise influence from external factors.

Intervention Type: DEVICE

Music listening

Patients will be given a mobile phone to choose their preferred music to be played during surgery. The music list contains songs across pre-saved playlists spanning different music genres compiled by the institution's music therapist to ensure adequate coverage of the various music genres and to promote relaxation and serenity.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. America Society of Anaesthesiologist (ASA) 1 to 3 adults undergoing procedures (surgery, pain procedures);

2. Able to read and understand English and/or Chinese;

3. Not receiving opioid prior to the procedures.

Exclusion Criteria

1. With chronic pain;

2. Opioid and drug abuse;

3. Scheduled postoperative Intensive care unit (ICU) admission;

4. With baseline non-sinus heart rhythm or on pacemaker support.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Changi General Hospital

Singapore, , Singapore

KK Women's and Children's Hospital

Singapore, , Singapore

Singapore General Hospital

Singapore, , Singapore

Countries

Singapore

Central Contacts

Ban Leong Sng

Role: CONTACT

sng.ban.leong@singhealth.com.sg

65 6394 8436

Facility Contacts

Prit Anand Singh

Role: primary

singh.prit.anand@singhealth.com.sg

65 6788 8833

Ban Leong Sng

Role: primary

sng.ban.leong@singhealth.com.sg

65 6394 8436

Diana Chan

Role: primary

diana.chan.x.h@singhealth.com.sg

65 63214604

Other Identifiers

2017/2930a

Identifier Type: -

Identifier Source: org_study_id