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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00728-43 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| music group | Experimental | music listening |
|
| no music group | Active Comparator | no music listening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music | Other | headphones with music |
| |
| No Music |
| Measure | Description | Time Frame |
|---|---|---|
| Hypertensive event | Non invasive measure through blood pressure cuff | Intraoperative every 5 minutes |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manon Guisse, nurse | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochin Hospital | Paris | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34658886 | Result | 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. | |
| 34323929 | Derived | 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. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Other |
headphones without music |
|
| Duration of surgery | after surgery |
| Intraoperative surgical complications | reported by surgeon | during surgery |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |