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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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. |
|
| 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:
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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the impact of music on the incidence of surgical complications | Incidence of posterior capsular rupture | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin/Port-Royal | Paris | France | ||||
| Eye Clinic, Department of Surgical Sciences, University of Cagliari |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| 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:
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. | Before surgery |
| Cagliari |
| Italy |
| University of Catanzaro | Catanzaro | 88100 | Italy |