- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07206186
- Original Trial
Effect of Music on Patient Comfort
Music Listening During Anesthesia Induction and Emergence: Assessing Its Role in Enhancing Patient Comfort
Perioperative anxiety remains a prevalent and significant concern for patients undergoing surgery, with substantial impacts on postoperative pain perception, patient satisfaction and recovery. Historically, anxiolytics (e.g. benzodiazepines) were often routinely administered preoperatively in this context, accepting the potential negative side effects of pharmacotherapy. In recent literature, there is an increasing focus on alternative, non-pharmacological methods for anxiety reduction, such as music, music therapy, virtual reality, and hypnosis.
Music can represent an effective and cost-efficient option to reduce perioperative anxiety and stress. Most randomized controlled trials on this topic (music group vs. non-music group) have been conducted in pediatric patient populations, often showing significant results (i.e. significantly less anxiety in the music group, measured using standardized scales or inventories). In adult patient populations, considerably fewer randomized controlled trials with music interventions for perioperative anxiety reduction have been conducted so far.
This study aims to evaluate the role of music during anesthesia induction and emergence for perioperative anxiety reduction in a randomized controlled trial. Patients will be randomized preoperatively into either the intervention group (50 patients, music) or the control group (50 patients, no music), and a baseline level of preoperative anxiety will be assessed using the State-Trait Anxiety Inventory (STAI). In the intervention group, music of the patient's choice will be played starting from their arrival in the operating room during anesthesia induction, and again after the end of surgery during emergence from anesthesia. Afterwards, the effects of the music intervention on the patients' subjective well-being will be assessed in the intervention group postoperatively before discharge from the recovery room using four specific questions. In both groups, the State Anxiety Inventory (SAI) portion of the STAI will also be administered and the results compared.
In addition, the NASA Task Load Index will be administered to the attending anesthesiologists in both groups to evaluate whether the subjective workload of the anesthesiologists changes as a result of the music intervention.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stefan Ulbing, Dr.med.univ.
- Phone Number: +43 40400 41020
- Email: stefan.ulbing@meduniwien.ac.at
Study Locations
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Vienna
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Vienna, Vienna, Austria, 1090
- Recruiting
- Medical University of Vienna
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Contact:
- Stefan Ulbing, Dr.med.univ.
- Phone Number: +43 40400 41020
- Email: stefan.ulbing@meduniwien.ac.at
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Principal Investigator:
- Marion Wiegele, Priv.-Doz. DDr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Written informed consent
- Elective ophthalmological surgery under general anesthesia (e.g. strabismus surgery, cataract surgery or other lens surgery, glaucoma surgery, keratoplasty or other corneal transplantation, vitrectomy or other retinal surgery, lacrimal duct surgery)
- Age: 18-70 years
- ASA score I-II (American Society of Anesthesiologists)
Exclusion Criteria:
- Pre-existing psychiatric disorder (e.g. anxiety disorder, PTSD, depression)
- Chronic pain patients
- Language barrier
- Anticipated difficult airway
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music group
After randomization, the intervention group will be asked which type of music they would like to listen to during anesthesia induction and emergence.
Upon arrival in the operating room, the selected music will be played from a wireless speaker at approximately 50-60 dB.
The volume will be continuously monitored using a sound level meter and adjusted as needed.
The music will stop once the airway is secured by the attending anesthetist (i.e.
following endotracheal intubation or placement of a laryngeal mask).
Music will resume after the surgery is completed, the bandage (if required) has been applied, and the administration of anesthetic medication has ceased.
Music will be paused again after anesthesia emergence as the patient leaves the operating room.
|
Music as per patient choice
|
|
No Intervention: Control group
The control group will not receive music during anesthesia induction or emergence.
However, the State Trait Anxiety Inventory (STAI) will be administered preoperatively as well as the State Anxiety Inventory (SAI) portion of the STAI postoperatively.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of listening to self-selected music during anesthesia induction and emergence on patient well-being
Time Frame: Postoperatively before discharge from the post-anesthesia care unit (PACU)
|
The primary objective of this randomized controlled trial is to assess the impact of listening to self-selected music during anesthesia induction and emergence on patient well-being, as measured by four specific questions:
These questions will be answered using a Likert scale (strongly disagree - disagreee - neither agree nor disagree - agree - strongly agree). |
Postoperatively before discharge from the post-anesthesia care unit (PACU)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sex-specific differences regarding the primary objective
Time Frame: Postoperatively before discharge from the post-anesthesia care unit (PACU)
|
Postoperatively before discharge from the post-anesthesia care unit (PACU)
|
|
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State Trait Anxiety Inventory (STAI)
Time Frame: Pre- and postoperatively
|
State Anxiety Inventory (SAI): pre- and postoperatively Trait Anxiety Inventory (TAI): preoperatively
|
Pre- and postoperatively
|
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NASA Task Load Index (attending anesthesiologist)
Time Frame: After anesthesia induction + after handover to the post-anesthesia care unit (PACU) team
|
The NASA Task Load Index will be completed twice by the attending anesthesiologist in the presence of the study team: once after anesthesia induction, once patient stability and adequate anesthesia are confirmed, and again after anesthesia delivery, once the patient is stable in the post-anesthesia care unit (PACU) and all relevant information has been relayed to the PACU team.
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After anesthesia induction + after handover to the post-anesthesia care unit (PACU) team
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Attempts at airway management
Time Frame: After anesthesia induction
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Intubation attempts Attempts to place a laryngeal mask
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After anesthesia induction
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Adverse events
Time Frame: During surgery
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Including but not limited to: Difficult intubation > 3 attempts Respiratory complications (e.g. bronchospasm, laryngospasm) Hemodynamic complications (severe hypotension (MAP >50 for more than 5 minutes), severe bradycardia (heart rate < 40)) Cardiac arrest |
During surgery
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Postoperative pain in the post-anesthesia care unit (PACU)
Time Frame: During the stay in the post-anesthesia care unit (PACU)
|
Opioid equivalents Non-opioid analgetic medication
|
During the stay in the post-anesthesia care unit (PACU)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marion Wiegele, Priv.-Doz. DDr., Medical University of Vienna
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1166/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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