Music's Impact on Preoperative Anxiety: Heart Rate Variability Study During Cataract Surgery

A

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Status

Enrolling

Conditions

Heart Rate Variability
Anxiety
Cataract Surgery

Treatments

Other: Music listening

Study type

Interventional

Funder types

Other

Identifiers

NCT06230029
Musictop2

Details and patient eligibility

About

The goal of this Randomized Controlled Trial is to evaluate heart rate variability (HRV)before and after listening to music in patients scheduled for cataract surgery under topical anesthesia, compared to patients who do not listen to music. Our hypothesis is that the anxious population with a low HRV benefits from an anxiolytic effect of music to increase HRV levels.

Enrollment

72 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • information and consent of the patient,
  • 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

  • Refusal to participate,
  • 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Music Listening
Experimental group
Description:
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.
Treatment:
Other: Music listening
No Music
No Intervention group
Description:
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.

Trial contacts and locations

3

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Central trial contact

Giuseppe Giannaccare

Data sourced from clinicaltrials.gov

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