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

NCT06461052 | Completed

• 2 other identifiers: 2021_01882023-A02493-42
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 2

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.

Conditions

Ambulatory Surgery

Outcome Measures

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).

  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.

  up to 24 hours

Secondary Outcomes (6)

• 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

• Compare anxiety levels in operating waiting room (T2)

  up to 24 hours

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

  up to 24 hours

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

  up to 24 hours

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

  up to 24 hours

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL

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

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient affiliated to a health insurance scheme

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (2)

DRCI FOCH Hospital

Suresnes, 92150, France

Location

FOCH Hospital

Suresnes, 92150, France

Location

Related Publications (8)

• Friedrich S, Reis S, Meybohm P, Kranke P. Preoperative anxiety. Curr Opin Anaesthesiol. 2022 Dec 1;35(6):674-678. doi: 10.1097/ACO.0000000000001186. Epub 2022 Sep 21.

  PMID: 36131642 BACKGROUND

• Maurice-Szamburski A, Auquier P, Viarre-Oreal V, Cuvillon P, Carles M, Ripart J, Honore S, Triglia T, Loundou A, Leone M, Bruder N; PremedX Study Investigators. Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial. JAMA. 2015 Mar 3;313(9):916-25. doi: 10.1001/jama.2015.1108.

  PMID: 25734733 BACKGROUND

• Eijlers R, Dierckx B, Staals LM, Berghmans JM, van der Schroeff MP, Strabbing EM, Wijnen RMH, Hillegers MHJ, Legerstee JS, Utens EMWJ. Virtual reality exposure before elective day care surgery to reduce anxiety and pain in children: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):728-737. doi: 10.1097/EJA.0000000000001059.

  PMID: 31356373 BACKGROUND

• Gurler H, Yilmaz M, Turk KE. Preoperative Anxiety Levels in Surgical Patients: A Comparison of Three Different Scale Scores. J Perianesth Nurs. 2022 Feb;37(1):69-74. doi: 10.1016/j.jopan.2021.05.013. Epub 2021 Nov 19.

  PMID: 34810072 BACKGROUND

• Hedayati J, Bagheri-Nesami M, Elyasi F, Hosseinnataj A. The Effect of Music Therapy on the Pain and Anxiety Levels of Patients Experiencing Wound Healing by Suturing in the Emergency Wards. Anesth Pain Med. 2023 Feb 25;13(1):e132943. doi: 10.5812/aapm-132943. eCollection 2023 Feb.

  PMID: 37409003 BACKGROUND

• Maurice-Szamburski A, Loundou A, Capdevila X, Bruder N, Auquier P. Validation of the French version of the Amsterdam preoperative anxiety and information scale (APAIS). Health Qual Life Outcomes. 2013 Oct 7;11:166. doi: 10.1186/1477-7525-11-166.

  PMID: 24099176 BACKGROUND

• Celik F, Edipoglu IS. Evaluation of preoperative anxiety and fear of anesthesia using APAIS score. Eur J Med Res. 2018 Sep 11;23(1):41. doi: 10.1186/s40001-018-0339-4.

  PMID: 30205837 BACKGROUND

• Eberhart L, Aust H, Schuster M, Sturm T, Gehling M, Euteneuer F, Rusch D. Preoperative anxiety in adults - a cross-sectional study on specific fears and risk factors. BMC Psychiatry. 2020 Mar 30;20(1):140. doi: 10.1186/s12888-020-02552-w.

  PMID: 32228525 BACKGROUND

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Morgan LE GUEN, MD

  FOCH Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective study, parallel group

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 14, 2024
• Study Start: March 12, 2024
• Primary Completion: July 5, 2024
• Study Completion: July 5, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)