Heart Rate Variability and Music Listening

NCT06929208 | Not Yet Recruiting DMC

• 1 other identifier: 2017/2930a
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Heart Rate Variability; Anxiety; Depression

Keywords

Anxiety; Depression; Heart rate variability

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Preoperative anxiety before and after music listening

  1 day

• Preoperative depression score before and after music listening

  1 day

Study Arms (1)

Single arm for HRV and music listening

EXPERIMENTAL

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

Device: Electrocardiogram (ECG) monitor; Other: Music listening

Interventions

Electrocardiogram (ECG) monitor 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.

Single arm for HRV and music listening

Music listening 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.

Single arm for HRV and music listening

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• America Society of Anaesthesiologist (ASA) 1 to 3 adults undergoing procedures (surgery, pain procedures);
• Able to read and understand English and/or Chinese;
• Not receiving opioid prior to the procedures.

You may not qualify if:

• With chronic pain;
• Opioid and drug abuse;
• Scheduled postoperative Intensive care unit (ICU) admission;
• With baseline non-sinus heart rhythm or on pacemaker support.

Sponsors & Collaborators

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

Study Sites (3)

Changi General Hospital

Singapore, Singapore

Location

KK Women's and Children's Hospital

Singapore, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Electrocardiography; Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Ban Leong Sng

CONTACT

65 6394 8436; sng.ban.leong@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Music listening and HRV measurements

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: April 16, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (3)