Effect of Music on Patient Comfort

NCT ID: NCT07206186

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-05
• Study Completion Date: 2026-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Music

Intervention Type: OTHER

Music as per patient choice

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music

Music as per patient choice

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Marion Wiegele

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marion Wiegele, Priv.-Doz. DDr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, Vienna, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Stefan Ulbing, Dr.med.univ.

Role: CONTACT

stefan.ulbing@meduniwien.ac.at

+43 40400 41020

Facility Contacts

Stefan Ulbing, Dr.med.univ.

Role: primary

stefan.ulbing@meduniwien.ac.at

+43 40400 41020

Other Identifiers

1166/2025

Identifier Type: -

Identifier Source: org_study_id