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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
142
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.
Hôpital Cochin/Port-Royal
Paris, France
Eye Clinic, Department of Surgical Sciences, University of Cagliari
Cagliari, Italy
University of Catanzaro
Catanzaro, Italy
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
Time frame: Baseline vs pre-surgery
Evaluation of the impact of music on the incidence of surgical complications
Incidence of posterior capsular rupture
Time frame: Immediately after the surgery
Measurement of subjective anxiety level
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.
Time frame: Before surgery
Measurement of subjective anxiety level
Visual Analogue scale (VAS). In this 5-score system, we employ illustrative facial expressions to represent varying degrees of anxiety. Each segment is paired with a distinct face, visually conveying the corresponding level of anxiety: 1. No Anxiety: The initial segment features a face showing calmness, symbolizing absence of anxiety. 2. Mild Anxiety: The second segment depicts a face with a slightly concerned expression, indicative of mild anxiety. 3. Moderate Anxiety: In the third segment, the face exhibits clear signs of worry, corresponding to moderate anxiety. 4. Severe Anxiety: The fourth segment portrays a face with a deeply troubled expression, denoting severe anxiety. 5. Extreme Anxiety: The final segment illustrates a face overwhelmed with distress, representing extreme or unbearable anxiety. Patients are invited to select the face that best aligns with their current perceived level of anxiety, enabling a more relatable and empathetic approach to self-assessment.
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Time frame: Before surgery