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NCT Number: NCT06467747

The Efficacy of Music on Perioperative Pain Management

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.

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Key information

Conditions

Perioperative Pain Management

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taichung, Not in USA, 427, Taiwan

Location status: Recruiting

Location contact

Mei-Ling Shen

CONTACT

[email protected]

+886-921126960

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Music

Other

Music group: wear earphones to listen to music and receive standardized anesthesia protocol

Mute

Other

Mute group: wear earphones without music and receive standardized anesthesia protocol

Primary outcomes

  1. Numeric Rating Scale (NRS)

    Time frame: 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 outcomes

  1. Analgesic-frequency

    Time frame: 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

  2. Analgesic-total amount

    Time frame: 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

  3. Post-operative nausea and vomiting (PONV)

    Time frame: 1. While in the post-anesthesia care unit, for an average of 1 hour.

    Frequency of nausea and vomiting episodes

Study contacts

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

Mei-Ling Shen

CONTACT

[email protected]

+886-921126960

Sponsors and collaborators

Lead sponsor

Taichung Tzu Chi Hospital

Other

Registry information

Official study title

The Efficacy of Intraoperative Music Stimulation on Perioperative Pain Management

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 21, 2024
Registry last updated
Aug 9, 2024

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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