跳至主要内容
临床试验/NCT06929208
NCT06929208招募中不适用

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

KK Women's and Children's Hospital3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年8月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
3
主要终点
Preoperative Heart rate variability (HRV) before, during and after music listening - low frequency (LF)-HRV

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

Single arm for HRV and music listening

Experimental

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

干预措施: Electrocardiogram (ECG) monitor (Device)

Single arm for HRV and music listening

Experimental

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

干预措施: Music listening (Other)

结局指标

主要结局

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

时间窗: 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.

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

时间窗: 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.

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

时间窗: 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.

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

时间窗: 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.

次要结局

  • Preoperative anxiety before and after music listening(1 day)
  • Preoperative depression score before and after music listening(1 day)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sng Ban Leong

Senior Consultant

KK Women's and Children's Hospital

研究点 (3)

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