Medical University of Vienna
Vienna, State of Vienna, 1090, Austria
NCT Number: NCT07206186
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Vienna, State of Vienna, 1090, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Music as per patient choice
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).
Time frame: Postoperatively before discharge from the post-anesthesia care unit (PACU)
Time frame: Pre- and postoperatively
State Anxiety Inventory (SAI): pre- and postoperatively Trait Anxiety Inventory (TAI): preoperatively
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.
Time frame: After anesthesia induction
Intubation attempts Attempts to place a laryngeal mask
Time frame: 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
Time frame: During the stay in the post-anesthesia care unit (PACU)
Opioid equivalents Non-opioid analgetic medication
Medical University of Vienna
Other
Music Listening During Anesthesia Induction and Emergence: Assessing Its Role in Enhancing Patient Comfort
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06860100
Cardiovascular Diseases, Digestive System Diseases
Van, Tuşba, Turkey (Türkiye)
View Trial DetailsNCT07495163
Major Abdominal Surgery, Perioperative Anxiety
Huzhou, Zhejiang, China
View Trial DetailsNCT07270029
Anxiety Disorders, Mental Disorders
Perth, Western Australia, Australia
View Trial DetailsNCT07134764
Behavior, Hemodynamic Stability
Sfax, Tunisia
View Trial Details