Effect of Music on Patient Comfort

Not Applicable

Recruiting

• Conditions: Perioperative Anxiety

• Registration Number: NCT07206186
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-05
• Status Verified: 2025-09
• Study First Submitted: 2025-09-25
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2026-05-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Impact of listening to self-selected music during anesthesia induction and emergence on patient well-being	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: 1. I enjoyed listening to the music I chose, during the anesthesia induction and emergence.; 2. Listening to the music I chose, during anesthesia induction and emergence had an anxiety relieving effect.; 3. Listening to the music I chose, during anesthesia induction and emergence had a stress-relieving effect.; 4. The next time I have a general anesthesia, I would like to listen to self-selected music during anesthesia induction and emergence.; These questions will be answered using a Likert scale (strongly disagree - disagreee - neither agree nor disagree - agree - strongly agree).

Secondary Outcome Measures

Name	Time	Method
State Trait Anxiety Inventory (STAI)	Pre- and postoperatively	State Anxiety Inventory (SAI): pre- and postoperatively Trait Anxiety Inventory (TAI): preoperatively
NASA Task Load Index (attending anesthesiologist)	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.
Sex-specific differences regarding the primary objective	Postoperatively before discharge from the post-anesthesia care unit (PACU)
Attempts at airway management	After anesthesia induction	Intubation attempts Attempts to place a laryngeal mask
Adverse events	During surgery	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
Postoperative pain in the post-anesthesia care unit (PACU)	During the stay in the post-anesthesia care unit (PACU)	Opioid equivalents Non-opioid analgetic medication

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Vienna, Austria