Perioperative Pain Management
Conditions
Keywords
Music therapy
Brief summary
The goal of this clinical trial is to learn if intraoperative music stimulation works to alleviate perioperative pain in surgical patients undergoing general anesthesia. It will also learn about the possible mechanisms by how music affects pain. The main questions it aims to answer are: Does music lower the number of times participants need to use a rescue analgesic? What changes occur in electroencephalogram (EEG) and nociception monitors when participants listen to music? Researchers will compare music to mute or control (hear ambient sounds without earphones) to see if music works to alleviate perioperative pain. Participants will listen music or mute or ambient sounds throughout the operation, and receive routine anesthesia care.
Interventions
OTHERMusic
Music group: wear earphones to listen to music and receive standardized anesthesia protocol
OTHERMute
Mute group: wear earphones without music and receive standardized anesthesia protocol
Sponsors
Taichung Tzu Chi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Older than 20 years old and younger than 80 years old * male or female * Scheduled for minimally invasive surgery (laparoscopic cholecystectomy, appendectomy) * Ambulatory surgery * American Society of Anesthesiologists (ASA) physical status I\ III
Exclusion criteria
* Severe hearing impairment * Severe pulmonary or cardiovascular disease * Brain or central nervous system (CNS) disorder * Long-term systemic steroid or daily morphine treatment * Pregnant women * Emergency surgery * The absence of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) | 1. While in the post-anesthesia care unit, for an average of 1 hour. 2. 24 hours after surgery. | To assess pain severity using a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable. Higher scores indicate greater pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic-frequency | 1. During the operation. 2. While in the post-anesthesia care unit, for an average of 1 hour. 3. 24 hours after surgery. | Frequency of analgesic usage |
| Analgesic-total amount | 1. During the operation. 2. While in the post-anesthesia care unit, for an average of 1 hour. 3. 24 hours after surgery. | Total amount of analgesic used |
| Post-operative nausea and vomiting (PONV) | 1. While in the post-anesthesia care unit, for an average of 1 hour. | Frequency of nausea and vomiting episodes |
Countries
Taiwan
Contacts
Primary ContactMei-Ling Shen
Outcome results
None listed