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

NCT06230029 | Completed

• 1 other identifier: Musictop2
• Study Type: interventional
• Target: 142
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Anxiety; Cataract Surgery; Heart Rate Variability

Outcome Measures

Primary Outcomes (1)

• Comparison of heart rate variability before vs after listening to music in patients scheduled for cataract surgery under topical anesthesia.

  Use of a non-invasive sensor: recording chest belt

  Baseline vs pre-surgery

Secondary Outcomes (3)

• Evaluation of the impact of music on the incidence of surgical complications

  Immediately after the surgery

• Measurement of subjective anxiety level

  Before surgery

• Measurement of subjective anxiety level

  Before surgery

Study Arms (2)

Music Listening

EXPERIMENTAL

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.

Other: Music listening

No Music

NO INTERVENTION

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.

Interventions

Music listening OTHER

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.

Music Listening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Mater Domini, Catanzaro: lead

Study Sites (3)

Hôpital Cochin/Port-Royal

Paris, France

Location

Eye Clinic, Department of Surgical Sciences, University of Cagliari

Cagliari, Italy

Location

University of Catanzaro

Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 29, 2024
• Study Start: December 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

FR (1); IT (2)