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NCT Number: NCT06929208

Heart Rate Variability and Music Listening

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.

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Key information

Conditions

Heart Rate Variability Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Preoperative Heart rate variability (HRV) before, during and after music listening - root mean square of successive differences NN intervals (rMSSD)

    Time frame: 1 day

    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.

  2. Preoperative Heart rate variability (HRV) before, during and after music listening - low frequency (LF)-HRV

    Time frame: 1 day

    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.

  3. Preoperative Heart rate variability (HRV) before, during and after music listening - High Frequency (HF)-HRV

    Time frame: 1 day

    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.

  4. Preoperative Heart rate variability (HRV) before, during and after music listening - LF/HF ratio

    Time frame: 1 day

    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.

Secondary outcomes

  1. Preoperative anxiety before and after music listening

    Time frame: 1 day

    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".

  2. Preoperative depression score before and after music listening

    Time frame: 1 day

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ban Leong Sng

CONTACT

[email protected]

65 6394 8436

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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