Clinical trial NCT02892825: Music Listening for Cataract Surgery
Official title: Impact of Music on Hypertension During Cataract Surgery Performed Under Topical Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Surgery
Keywords: Music
cataract surgery
topical anaesthesia
anxiety
hypertension
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hypertensive event
timeFrame: Intraoperative every 5 minutes
Secondary outcomes:
measure: Anxiety score before surgery
timeFrame: before surgery
measure: Anxiety score after surgery
timeFrame: after surgery
measure: Duration of surgery
timeFrame: after surgery
measure: Intraoperative surgical complications
timeFrame: during surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Manon Guisse, nurse
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guerrier G, Bernabei F, Lehmann M, Pellegrini M, Giannaccare G, Rothschild PR. Efficacy of Preoperative Music Intervention on Pain and Anxiety in Patients Undergoing Cataract Surgery. Front Pharmacol. 2021 Sep 30;12:748296. doi: 10.3389/fphar.2021.748296. eCollection 2021.
citation: Guerrier G, Abdoul H, Jilet L, Rothschild PR, Baillard C. Efficacy of a Web App-Based Music Intervention During Cataract Surgery: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Sep 1;139(9):1007-1013. doi: 10.1001/jamaophthalmol.2021.2767.