Music Listening for Cataract Surgery

Study Overview
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Brief Summary
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The purpose of the study is to assess the effect of music therapy on anxiety and hypertension during cataract surgery procedures performed under topical anaesthesia.

Detailed Description
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Cataract surgery is the most frequent surgical procedure performed in Europe, usually done under topical anaesthesia. Restlessness and hypertension are the most frequent medical complications during surgery, potentially leading to surgical complications. Since the surgery is ambulatory and requires the patient's cooperation, heavy intravenous sedation should be avoided. However, this procedure is stressful, with patients experiencing high anxiety due to being awake and aware of the procedure on their eye and equipment. Music therapy may be considered as a non-pharmacologic and non-invasive mean to reduce anxiety and therefore intra-operative hypertension. To assess the effect of music therapy on anxiety and hypertension during cataract surgery procedures under topical anaesthesia, investigators intend to perform a randomized controlled trial. Depending on the results of the study, music therapy may subsequently be replacing the usual premedication before surgery.

Official Title
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Impact of Music on Hypertension During Cataract Surgery Performed Under Topical Anaesthesia

Conditions
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Cataract Surgery

Intervention / Treatment
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* Other: Music
* Other: No Music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective cataract surgery performed under topical anaesthesia Exclusion Criteria: Non topical anaesthesia Non ambulatory surgery Communication difficulties including language barrier, and mental disorders Age<18yo Hearing impairment Uncontrolled hypertension

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: music group<br>music listening | Other: Music<br>* headphones with music<br>|
| Active Comparator: no music group<br>no music listening | Other: No Music<br>* headphones without music<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertensive event | Non invasive measure through blood pressure cuff | Intraoperative every 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety score before surgery | on a visual analogue scale | before surgery | 
| Anxiety score after surgery | on a visual analogue scale | after surgery | 
| Duration of surgery |  | after surgery | 
| Intraoperative surgical complications | reported by surgeon | during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music, cataract surgery, topical anaesthesia, anxiety, hypertension