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

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)

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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.