An interventional study of Music listening in Anxiety, Cataract Surgery and Heart Rate Variability, sponsored by Azienda Ospedaliera Universitaria Mater Domini, Catanzaro. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Azienda Ospedaliera Universitaria Mater Domini, Catanzaro · Not applicable, Interventional, and Supportive care
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 142 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Azienda Ospedaliera Universitaria Mater Domini, Catanzaro is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
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.
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.
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.
Time frame: Before surgery
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera Universitaria Mater Domini, Catanzaro