Heart Rate Variability and Music Listening

Investigating the Association Between Heart Rate Variability and Music Listening Prior to Procedures: A Pilot Cohort Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Anxiety; Heart Rate Variability
• Intervention / Treatment: Device: Electrocardiogram (ECG) monitor; Other: Music listening

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ban Leong Sng; Phone Number: 65 6394 8436; Email: sng.ban.leong@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Singapore General Hospital
    • Contact: Diana Chan; Phone Number: 65 63214604; Email: diana.chan.x.h@singhealth.com.sg
  • Singapore, Singapore
    • KK Women's and Children's Hospital
    • Contact: Ban Leong Sng; Phone Number: 65 6394 8436; Email: sng.ban.leong@singhealth.com.sg
  • Singapore, Singapore
    • Changi General Hospital
    • Contact: Prit Anand Singh; Phone Number: 65 6788 8833; Email: singh.prit.anand@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single arm for HRV and music listening; ECG recording for HRV data before, during and after music listening

Device: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative Heart rate variability (HRV) before, during and after music listening - root mean square of successive differences NN intervals (rMSSD)	Preoperative HRV parameters on root mean square of successive differences NN intervals (rMSSD) will be collected before, during and after music listening, with a sampling rate of 1000Hz, 5-10-minutes duration.	1 day
Preoperative Heart rate variability (HRV) before, during and after music listening - low frequency (LF)-HRV	Preoperative HRV parameters on low frequency (LF)-HRV will be collected before, during and after music listening, with a sampling rate of 1000Hz, 5-10-minutes duration.	1 day
Preoperative Heart rate variability (HRV) before, during and after music listening - High Frequency (HF)-HRV	Preoperative HRV parameters on High Frequency (HF)-HRV will be collected before, during and after music listening, with a sampling rate of 1000Hz, 5-10-minutes duration.	1 day
Preoperative Heart rate variability (HRV) before, during and after music listening - LF/HF ratio	Preoperative HRV parameters on LF/HF ratio will be collected before, during and after music listening, with a sampling rate of 1000Hz, 5-10-minutes duration.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative anxiety before and after music listening	Before and after music listening, a visual analogue scale depicting anxiety (VAS-A) comprises a 10 cm line will be administered, on which the participant marks the current degree of anxiety with the left end of the line being labelled "no anxiety" and the right end being labelled "maximum anxiety".	1 day
Preoperative depression score before and after music listening	Before and after music listening, depression score will also be collected via Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 questions about the patient's feelings, with each question scored from 0 to 3 based on the frequency of symptom; hence having a total score ranging from 0 to 27. Scores of 0 to 4 depicts no depression, whereas 5 to 9 may indicate a mild depression. 10 and above will indicate moderate/severe depression.	1 day

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: April 12, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Heart rate variability
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2017/2930a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To be shared upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No