Anxiety, Depression, Heart Rate Variability
Conditions
Keywords
Anxiety, Depression, Heart rate variability
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.
Interventions
DEVICEElectrocardiogram (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.
OTHERMusic 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.
Sponsors
KK Women's and Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Music listening and HRV measurements
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative Heart rate variability (HRV) before, during and after music listening - root mean square of successive differences NN intervals (rMSSD) | 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 - low frequency (LF)-HRV | 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 - High Frequency (HF)-HRV | 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. |
| Preoperative Heart rate variability (HRV) before, during and after music listening - LF/HF ratio | 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
| Measure | Time frame | Description |
|---|---|---|
| Preoperative anxiety before and after music listening | 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". |
| Preoperative depression score before and after music listening | 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. |
Countries
Singapore
Contacts
CONTACTBan Leong Sng
PRINCIPAL_INVESTIGATORBan Leong Sng
KK Women's and Children's Hospital
Outcome results
None listed