Music therapy impact during anaesthesia for gastrointestinal endoscopy
| ISRCTN | ISRCTN13545435 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13545435 |
| Secondary identifying numbers | 23-15 |
- 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
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
Public, Scientific, Principal investigator
Centre Hospitalier Princesse Grace
Service d'anesthésie réanimation
1 avenue Pasteur
Monaco
98000
Monaco
| Phone | +377 (0)97989900 |
|---|---|
| gildas.rousseau@chpg.mc |
Study information
| Study design | Open‑label single‑centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a 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 | 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) |
| Secondary outcome measures | 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 |
| Overall study start date | 07/11/2023 |
| Completion date | 06/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 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
Monaco
98000
Monaco
Sponsor information
Hospital/treatment centre
1 avenue Pasteur
Monaco
98000
Monaco
| Phone | +377 (0)97988445 |
|---|---|
| recherche.clinique@chpg.mc | |
| Website | http://www.chpg.mc/en/ |
"ROR" |
https://ror.org/03x1jt541 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| 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. |
Editorial Notes
31/10/2025: Study's existence confirmed by the Princess Grace Hospital Centre.
