Ambulatory SurgeryHarmonieNCT06461052
Information and Music Therapy as a Means of Reducing Preoperative Anxiety in Outpatient Surgery.
A study testing music therapy in people with Ambulatory Surgery, run by Hopital Foch at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ambulatory Surgery
- What is being tested?
- music therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Mar 2024to 5 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Information and Music Therapy as a Means of Reducing Preoperative Anxiety in Outpatient Surgery. Outpatient Surgery: a Before-and-after Study
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.
Read the 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.
- Conditions
- Ambulatory Surgery
- Being tested
- music therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| 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. Receives: Procedure: music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: up to 24 hours
Compare anxiety levels in operating waiting room (T2)
VAS score in operating room waiting room (T2). A range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: up to 24 hours
Compare the time to loss of consciousness measured in the operating room between both groups
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)
Measured: up to 24 hours
Compare the amount of propofol (mg/kg) at induction required to achieve loss of consciousness between the two groups.
Amount of propofol (mg/kg) at induction required to achieve loss of consciousness
Measured: up to 24 hours
Evaluate the level of satisfaction of each action implemented using a specific questionnaire at the end of the program.
Level of satisfaction using a specific questionnaire at the end of the Licker scale
Measured: up to 24 hours
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.
Action completed in full or partially yes or no
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start12 Mar 2024
- Primary completion5 Jul 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ambulatory SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective study, parallel group
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan LE GUEN, MD, Principal investigator, FOCH Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461052
- Sponsor's protocol ID
- 2021_0188
- Other IDs
- 2023-A02493-42
- Acronym
- Harmonie
- Status last verified
- Feb 2025
- First submitted
- 24 May 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36131642Maurice-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.
PubMed 25734733Eijlers 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.
PubMed 31356373Gurler 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.
PubMed 34810072Hedayati 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.
PubMed 37409003Maurice-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.
PubMed 24099176Celik 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.
PubMed 30205837Eberhart 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.
PubMed 32228525Frohlich A, Martin A, He P, Landais C, Fischler M, Le Guen M. Impact of additional tailored Information and music to reduce preoperative anxiety in surgical outpatients: a prospective before-after study. Anaesth Crit Care Pain Med. 2026 Oct 27:101961. doi: 10.1016/j.accpm.2026.101961. Online ahead of print.
PubMed 42946129
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information and Music Therapy as a Means of Reducing Preoperative Anxiety in Outpatient Surgery. Outpatient Surgery: a Before-and-after Study
- ClinicalTrials.gov ID
- NCT06461052
- Acronym / sponsor ID
- Harmonie / 2021_0188
- Conditions
- Ambulatory Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective study, parallel group
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Procedure: music therapypatient information via a video explaining the procedure, followed by a15-minute music therapy session of your choice in the OR waiting room. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music therapyThe 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. | Procedure or surgery | Intervention |
Primary outcome
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.
6 secondary outcomes
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
Compare anxiety levels in operating waiting room (T2)
Time frame: up to 24 hours
Compare the time to loss of consciousness measured in the operating room between both groups
Time frame: up to 24 hours
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Results publication: PubMed 36131642Friedrich 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.
- Results publication: PubMed 25734733Maurice-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.
- Results publication: PubMed 31356373Eijlers 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.
- Results publication: PubMed 34810072Gurler 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.
- Results publication: PubMed 37409003Hedayati 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.
- Results publication: PubMed 24099176Maurice-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.
- Results publication: PubMed 30205837Celik 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.
- Results publication: PubMed 32228525Eberhart 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.
- Derived from this study: PubMed 42946129Frohlich A, Martin A, He P, Landais C, Fischler M, Le Guen M. Impact of additional tailored Information and music to reduce preoperative anxiety in surgical outpatients: a prospective before-after study. Anaesth Crit Care Pain Med. 2026 Oct 27:101961. doi: 10.1016/j.accpm.2026.101961. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgan LE GUEN, MD principal investigator
FOCH Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music therapy in people with Ambulatory Surgery, run by Hopital Foch at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06461052, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.