Cochin Hospital
Paris, 75014, France
NCT Number: NCT02892825
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75014, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
headphones with music
headphones without music
Time frame: Intraoperative every 5 minutes
Non invasive measure through blood pressure cuff
Time frame: before surgery
on a visual analogue scale
Time frame: after surgery
on a visual analogue scale
Time frame: after surgery
Time frame: during surgery
reported by surgeon
Assistance Publique - Hôpitaux de Paris
Other
Impact of Music on Hypertension During Cataract Surgery Performed Under Topical Anaesthesia
Acronym: MUSICATOP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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