Music's Impact on Preoperative Anxiety: Heart Rate Variability Study During Cataract Surgery
- Conditions
- AnxietyHeart Rate VariabilityCataract Surgery
- Interventions
- Other: Music listening
- Registration Number
- NCT06230029
- Lead Sponsor
- Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Music Listening Music listening 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.
Trial Locations
- Locations (3)
Eye Clinic, Department of Surgical Sciences, University of Cagliari
🇮🇹Cagliari, Italy
Hôpital Cochin/Port-Royal
🇫🇷Paris, France
University of Catanzaro
🇮🇹Catanzaro, Italy