Information and Music Therapy as a Means of Reducing Preoperative Anxiety in Outpatient Surgery.
- Conditions
- Ambulatory Surgery
- Interventions
- Procedure: music therapy
- Registration Number
- NCT06461052
- Lead Sponsor
- Hopital Foch
- Brief Summary
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.
- Detailed Description
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 need for more anesthetic agents to achieve the same level of depth of anesthesia in anxious patients compared to non-anxious/low-anxiety patients
* Development of chronic postoperative pain.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 198
- Any patient over the age of 18 undergoing scheduled outpatient surgery in the central
- under general anesthesia. The surgeries surgeries concerned are versatile: Digestive (inguinal hernias, proctology, cholecystectomy, etc.), thoracic endoscopy (biopsy examination under GA), gynecological (hysteroscopy, diagnostic laparoscopy diagnostic laparoscopy, cerclage...), ENT (endoscopies, septoplasty, meatotomy...), Urology (JJ catheter insertionTOT/TVT, botulinum toxin injection...), vascular (stripping)
- Patient with oral non-opposition prior to any study procedure
- Not to have objected to inclusion in the research
- Patient affiliated to a health insurance scheme
- Patients undergoing emergency surgery, considered full stomach
- Patient not respecting the central block route (interventional radiology in this case)
- First patients in the program because they present the risk of less than than 15 minutes
- Patients who do not understand French
- Patient deprived of liberty or under guardianship
- Pregnant or breast-feeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention music therapy patient information via a video explaining the procedure, followed by a15-minute music therapy session of your choice in the OR waiting room.
- Primary Outcome Measures
Name Time Method 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). up to 24 hours 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.
- Secondary Outcome Measures
Name Time Method 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 up to 24 hours 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
Compare the time to loss of consciousness measured in the operating room between both groups up to 24 hours 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)
Compare anxiety levels in operating waiting room (T2) up to 24 hours VAS score in operating room waiting room (T2). A range of scores from 0-100. A higher score indicates greater pain intensity.
Compare the amount of propofol (mg/kg) at induction required to achieve loss of consciousness between the two groups. up to 24 hours Amount of propofol (mg/kg) at induction required to achieve loss of consciousness
Evaluate the level of satisfaction of each action implemented using a specific questionnaire at the end of the program. up to 24 hours Level of satisfaction using a specific questionnaire at the end of the Licker scale
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. up to 24 hours Action completed in full or partially yes or no
Trial Locations
- Locations (2)
DRCI FOCH Hospital
🇫🇷Suresnes, France
FOCH Hospital
🇫🇷Suresnes, France