An interventional study of music therapy in Ambulatory Surgery, sponsored by Hopital Foch. Completed at 2 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Hopital Foch · Not applicable, Interventional, and Prevention
This is a monocentric, prospective, before-and-after, open-label controlled study, two groups of 99 patients each: "control" group - usual care - versus "intervention" group "Intervention" group - patient information via an explanatory video followed by a 15-minute music therapy session of the patient's choice in the operating waiting room.
Although general anaesthesia is used for almost 10 million procedures a year, and the safety of this procedure has improved considerably over the last 25 years, notably with the "safety decree" of December 1994, general anaesthesia remains deeply associated with high levels of preoperative anxiety. Anxiety levels are correlated with two perioperative factors:
The preoperative consultation and visit by an anaesthetist is an important meeting point to reduce these high levels of anxiety. On the other hand, systematic benzodiazepine-based premedication has been abandoned for some years now, and taking action to reduce the level of anxiety is one of today's challenges, using a variety of means: organizational, video, music, virtual reality, hypnosis...
Unfortunately, the level of publication on the subject remains low.
Currently, a local analysis of this pathway shows several waiting times for which patients are not necessarily informed, and which can generate anxiety during treatment. In addition, our preliminary survey on the subject showed a specific need for information on pain management and anaesthesia recovery. and anesthesia recovery.
The goal of this study was to design a two-group comparative study aiming of significantly reducing perioperative anxiety in outpatients by implementing simple solutions. More specifically, our project focuses on the impact of music therapy and dedicated information via an explanatory video of the patient's journey through the operating room on the level of perioperative anxiety.
Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patient information via a video explaining the procedure, followed by a15-minute music therapy session of your choice in the OR waiting room.
Procedure: music therapy
The patient will benefit from viewing the video and the music therapy session in the waiting room of the operating room. The patient will be asked again for their anxiety score using an anxiety scale. This will define the main outcome of the study. Following this collection and in order not to influence the response, investigators will collect from the patient his compliance with the two proposed techniques as well as his appreciation of the tool.
Compare the proportion of patients with high anxiety (Visual Analog Score (VAS) for pain greater than or equal to 40/100) in operating waiting room between the two groups (before and after implementation of the actions).
The primary endpoint was the presence or absence of high anxiety in operating waiting room (T2), measured by an VAS score \> 40/100. A range of scores from 0-100. A higher score indicates greater pain intensity.
Time frame: up to 24 hours
Compare anxiety levels in preoperative reception unit (T1) and in post anesthesia care unit room (T3) between the two groups: Amsterdam Preoperative Anxiety and Information Scale (APAIS) and VAS score
VAS score and APAIS in preoperative reception unit (T1) and in post anesthesia care unit room (T3). A range of scores from 0-100. A higher score indicates greater pain intensity. The APAIS scale is a six-item questionnaire graded on a five-point Likert scale from 1=not at all to 5=extremely
Time frame: up to 24 hours
Compare anxiety levels in operating waiting room (T2)
VAS score in operating room waiting room (T2). A range of scores from 0-100. A higher score indicates greater pain intensity.
Time frame: up to 24 hours
Compare the time to loss of consciousness measured in the operating room between both groups
Time to loss of consciousness measured in the operating room (time between injection of hypnotic agent (propofol) and a sleep depth measurement less than 60)
Time frame: up to 24 hours
Compare the amount of propofol (mg/kg) at induction required to achieve loss of consciousness between the two groups.
Amount of propofol (mg/kg) at induction required to achieve loss of consciousness
Time frame: up to 24 hours
Evaluate the level of satisfaction of each action implemented using a specific questionnaire at the end of the program.
Level of satisfaction using a specific questionnaire at the end of the Licker scale
Time frame: up to 24 hours
Evaluate the proportion of dropouts for each action, i.e. the proportion of patients who did not viewed the video until the end, or did not complete the entire music therapy session.
Action completed in full or partially yes or no
Time frame: up to 24 hours
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Hopital Foch