Anxiety, Cataract Surgery, Heart Rate Variability
Conditions
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.
Interventions
OTHERMusic 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.
Sponsors
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of heart rate variability before vs after listening to music in patients scheduled for cataract surgery under topical anesthesia. | Baseline vs pre-surgery | Use of a non-invasive sensor: recording chest belt |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the impact of music on the incidence of surgical complications | Immediately after the surgery | Incidence of posterior capsular rupture |
| Measurement of subjective anxiety level | Before surgery | Surgical Fear Questionnaire (SFQ): The questionnaire consists of 8 questions (items). The Items 1-4 refer to the subscale 'fear of short term consequences of surgery', the items 5-8 refer to the subscale 'fear of long term consequences of surgery'. All items are scored on an eleven point numeric rating scale (NRS) ranging from 0 (not at all afraid) to 10 (very afraid). This results in a total score of 0 to 80, calculated by summing item 1-8. |
Countries
France, Italy
Outcome results
None listed