Music therapy impact during anaesthesia for gastrointestinal endoscopy

ISRCTN	ISRCTN13545435
DOI	https://doi.org/10.1186/ISRCTN13545435
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	Nil known
Protocol serial number	23-15
Sponsor	Princess Grace Hospital Centre
Funder	Investigator initiated and funded

Submission date: 31/10/2025
Registration date: 03/11/2025
Last edited: 31/10/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Ambulatory gastrointestinal (GI) endoscopy constitutes a large and growing share of procedural care. Anxiety correlates with fears about anaesthesia, pain, and adverse outcomes, and when not controlled, higher doses of hypnotics and analgesics are typically required. Music has long been integrated into medical practice and, in modern trials, has demonstrated clinically relevant benefits. Across adult surgical settings, music interventions reduce anxiety and improve pain outcomes when compared with usual care or silence. This study aims to find out whether patient‑selected music reduces propofol requirements during combined upper and lower gastrointestinal endoscopy.

Who can participate?
Outpatients aged 18 years and over scheduled for diagnostic gastroscopy and colonoscopy

What does the study involve?
Patients are randomly allocated to patient-selected music plus standard care or to standard care alone.

What are the possible benefits and risks of participating?
Benefits: reduced anxiety and propofol consumption
Risks: no additional risks, same as standard of care

Where is the study run from?
Princess Grace Hospital Center (Monaco)

When is the study starting and how long is it expected to run for?
November 2023 to October 2025

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
1. Dr Gildas Rousseau, gildas.rousseau@chpg.mc
2. Nicolas Rijo, recherche.clinique@chpg.mc
3. Dr Sorina-Dana Mihailescu, recherche.clinique@chpg.mc

Contact information

Dr Gildas Rousseau
Public, Scientific, Principal investigator

Centre Hospitalier Princesse Grace
Service d'anesthésie réanimation
1 avenue Pasteur
Monaco
98000
Monaco

Phone	+377 (0)97989900
Email	gildas.rousseau@chpg.mc

Study information

Primary study design	Interventional
Study design	Open‑label single‑centre randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Patient‑selected music reduces propofol requirements during combined upper and lower gastrointestinal endoscopy: a randomized controlled trial
Study acronym	MUSICENDO
Study objectives	Music interventions can decrease sedative requirements and can reduce perioperative anxiety
Ethics approval(s)	Ethics approval not required
Health condition(s) or problem(s) studied	Anxiety during gastroscopy and colonoscopy
Intervention	This is an open‑label, single‑centre, randomized, controlled trial conducted at Princess Grace Hospital, Monaco. Consecutive adult outpatients scheduled for diagnostic gastroscopy and colonoscopy will be screened. Patients are allocated 1:1 to patient‑selected music plus standard care or to standard care alone using a computer-generated schedule with fixed permuted blocks.
Intervention type	Other
Primary outcome measure(s)	Propofol consumption rate (mg·kg⁻¹·min⁻¹), defined as total propofol administered divided by body weight and by the intervention length (minutes from induction to procedure end)
Key secondary outcome measure(s)	1. Procedure duration (minutes), from induction to end of procedure 2. Total ambulatory pathway time (minutes), from induction to return to ambulatory unit 3. Anxiety level measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) score at preanaesthesia consultation and on arrival in the ambulatory unit 4. Haemodynamic changes (systolic and diastolic blood pressures and pulse pressure) before vs after procedure 5. Adverse events (e.g., bronchospasm, laryngospasm) recorded during procedure 6. Number of propofol vials used per case for the procedure
Completion date	06/10/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	88
Total final enrolment	89
Key inclusion criteria	Adults with ASA physical status I–III planned for combined diagnostic upper and lower GI endoscopy in ambulatory care
Key exclusion criteria	1. Legal incapacity 2. Hospital stay >24 h 3. Psychiatric disorders 4. Alcohol or toxic substance use 5. Severe renal failure (creatinine clearance <30 mL·min⁻¹) 6. Pregnancy or breastfeeding 7. Significant hearing impairment precluding music exposure 8. Urgent procedures 9. Lack of social insurance
Date of first enrolment	20/03/2024
Date of final enrolment	16/07/2024

Locations

Countries of recruitment

Monaco

Study participating centre

Centre Hospitalier Princesse Grace

1 avenue Pasteur
Monaco
98000
Monaco

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Data will be shared with researchers who submit a methodologically sound protocol to Gildas Rousseau (gildas.rousseau@chpg.mc) following the signing of a data access agreement.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

31/10/2025: Study's existence confirmed by the Princess Grace Hospital Centre.