Effect of Music on Patient Comfort

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMedical University of Vienna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Pre-existing psychiatric disorder (e.g. anxiety disorder, PTSD, depression)

Chronic pain patients

Language barrier

Anticipated difficult airway

Trial design

Design model

Parallel

Treatments tested in this trial

  • Music

    Other intervention

    Music as per patient choice

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Music groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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).

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

Secondary outcomes

1

Sex-specific differences regarding the primary objective

Time frame
Postoperatively before discharge from the post-anesthesia care unit (PACU)
2

State Trait Anxiety Inventory (STAI)

State Anxiety Inventory (SAI): pre- and postoperatively Trait Anxiety Inventory (TAI): preoperatively

Time frame
Pre- and postoperatively
3

NASA Task Load Index (attending anesthesiologist)

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.

Time frame
After anesthesia induction + after handover to the post-anesthesia care unit (PACU) team
4

Attempts at airway management

Intubation attempts Attempts to place a laryngeal mask

Time frame
After anesthesia induction

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.