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Completed

NCT Number: NCT06461052

Information and Music Therapy as a Means of Reducing Preoperative Anxiety in Outpatient Surgery.

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.

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Key information

Conditions

Ambulatory Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DRCI FOCH Hospital, Suresnes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Music Therapy

Procedure

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.

Primary outcomes

  1. 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).

    Time frame: 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 outcomes

  1. 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

    Time frame: 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

  2. Compare anxiety levels in operating waiting room (T2)

    Time frame: 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.

  3. Compare the time to loss of consciousness measured in the operating room between both groups

    Time frame: 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)

  4. Compare the amount of propofol (mg/kg) at induction required to achieve loss of consciousness between the two groups.

    Time frame: up to 24 hours

    Amount of propofol (mg/kg) at induction required to achieve loss of consciousness

  5. Evaluate the level of satisfaction of each action implemented using a specific questionnaire at the end of the program.

    Time frame: up to 24 hours

    Level of satisfaction using a specific questionnaire at the end of the Licker scale

  6. 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.

    Time frame: up to 24 hours

    Action completed in full or partially yes or no

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Information and Music Therapy as a Means of Reducing Preoperative Anxiety in Outpatient Surgery. Outpatient Surgery: a Before-and-after Study

Acronym: Harmonie

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2024
Registry last updated
Feb 12, 2025

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.

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