Effect of Music on Patient Comfort

NCT07206186 | Recruiting

• 1 other identifier: 1166/2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Anxiety

Keywords

Perioperative Anxiety; Music; Music intervention; State Trait Anxiety Inventory (STAI); NASA Task Load Index; Anesthesia; Patient Comfort

Outcome Measures

Primary Outcomes (1)

• Impact of listening to self-selected music during anesthesia induction and emergence on patient well-being

  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).

  Postoperatively before discharge from the post-anesthesia care unit (PACU)

Secondary Outcomes (6)

• Sex-specific differences regarding the primary objective

  Postoperatively before discharge from the post-anesthesia care unit (PACU)

• State Trait Anxiety Inventory (STAI)

  Pre- and postoperatively

• NASA Task Load Index (attending anesthesiologist)

  After anesthesia induction + after handover to the post-anesthesia care unit (PACU) team

• Attempts at airway management

  After anesthesia induction

• Adverse events

  During surgery

Study Arms (2)

Music group

EXPERIMENTAL

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.

Other: Music

Control group

NO INTERVENTION

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.

Interventions

Music OTHER

Music as per patient choice

Music group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pre-existing psychiatric disorder (e.g. anxiety disorder, PTSD, depression)
• Chronic pain patients
• Language barrier
• Anticipated difficult airway
• Pregnancy

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Marion Wiegele, Priv.-Doz. DDr.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Ulbing, Dr.med.univ.

CONTACT

+43 40400 41020; stefan.ulbing@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the study design (i.e. listening to music over a speaker), masking is not possible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: June 5, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)