Music's Impact on Preoperative Anxiety: Heart Rate Variability Study During Cataract Surgery
NCT ID: NCT06230029
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
142 participants
INTERVENTIONAL
2023-12-01
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Music Listening
The presentation of the music listening session will be standardized and will be as follows: "Make yourself comfortable; we will first choose the musical style; then adjust the volume; put on the headphones; then the mask; let us know if something is wrong; we can take off the headphones or the mask at any time if you wish; we will stay by your side".
The following data will be collected just before the headset is put on and just after its removal:
* heart rate using a previously disinfected chest belt (PolarH10®)
* blood pressure
* level of anxiety (according to the validated SFQ and VAS scales)
Music listening session will last 15 minutes, at the end of which the headphones will be removed before the patient is transferred to the operating room.
Music listening
Music will be played through individual headphones (BOSE AE2®). The headphones give the impression of personalized music that only the patient can hear. Patients will have a mask over their eyes to limit visual aggression. The songs will be pre-recorded on a digital tablet (Samsung Galaxy®) allowing the broadcasting of music programs. Patients will have the choice to listen to a song according to their musical preferences among 16 different musical styles. The volume will be adapted to the level that suits the patient.
No Music
Heart rate variability monitoring while NOT listening to music. The presentation for the patients included in the group without music will be as follows: "Make yourself comfortable; we will first put on the headphones but there will be no music; let us know if anything is wrong; we can remove the headphones or mask at any time if you wish; we will stay by your side".
The following data will be collected just before the headset is put on and just after its removal:
* heart rate using a previously disinfected chest belt (PolarH10®)
* blood pressure
* level of anxiety (according to the validated SFQ and VAS scales)
The session will last 15 minutes, at the end of which the headphones will be removed before the patient is transferred to the operating room.
No interventions assigned to this group
Interventions
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Music listening
Music will be played through individual headphones (BOSE AE2®). The headphones give the impression of personalized music that only the patient can hear. Patients will have a mask over their eyes to limit visual aggression. The songs will be pre-recorded on a digital tablet (Samsung Galaxy®) allowing the broadcasting of music programs. Patients will have the choice to listen to a song according to their musical preferences among 16 different musical styles. The volume will be adapted to the level that suits the patient.
Eligibility Criteria
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Inclusion Criteria
* age greater than or equal to 18 years,
* affiliation to a social security system,
* benefiting from non-emergency ambulatory cataract surgery under topical anesthesia
* not being under legal protection.
Exclusion Criteria
* language barriers that are incompatible with a reliable assessment
* use of beta-blockers, including eye drops
* use of adrenergic, antiadrenergic, cholinergic and anticholinergic drugs
* use of psychotropic drugs, anxiolytics.
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
OTHER
Responsible Party
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Giuseppe Giannaccare
Professor
Locations
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Hôpital Cochin/Port-Royal
Paris, , France
Eye Clinic, Department of Surgical Sciences, University of Cagliari
Cagliari, , Italy
University of Catanzaro
Catanzaro, , Italy
Countries
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Other Identifiers
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Musictop2
Identifier Type: -
Identifier Source: org_study_id
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