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What are the effects of a web app–based music intervention on anxiety and hypertensive events during cataract surgery?
In this randomized clinical trial of 309 adults, the proportion of hypertensive events was 14% in the group receiving music intervention vs 53% in the group without a music intervention.
Before cataract surgery, use of a web app–based music intervention may be of interest because this trial showed it could reduce a participant’s anxiety levels and hypertension.
Hypertensive events during cataract surgery may induce complications. Information and communication technologies applied to health are popular, but clinical evidence of its usefulness is rare and limited to treating anxiety without specific analysis. Recent publications have described the potential effects of personalized music choices as mobile-based intervention on pain but not on anxiety.
To demonstrate the effects of a web app–based music intervention on the incidence of hypertension in participants during cataract surgery performed under local anesthesia.
Design, Setting, and Participants
This randomized, single masked, controlled clinical trial was composed of 2 arms and took place at asingle center at Cochin Hospital in Paris, France.A total of 313 participants were screened between February 2017 and July 2018. Among these, 311 participants undergoing a phacoemulsification procedure for elective surgery for their first eye cataract under local anesthesia were enrolled. Analysis was intention to treat and began in September 2018 and ended November 2018.
Participants requiring cataract surgery were assigned randomly to either the experimental arm (web app–based music listening intervention delivered via headphones) or control arm (noise-canceling headphones without music) for 20 minutes before surgery.
Main Outcomes and Measures
The occurrence of at least 1 hypertensive event during surgery.
A total of 310 participants were randomized in the study (155 to each arm) and 309 were analyzed (1 participant in the music arm had already undergone cataract surgery to the other eye). The mean (SD) age of the participants was 68.9 (10.8) years, and there were 176 female individuals (57%). On the primary end point, the incidence of hypertension was significantly lower in the music arm (21 [13.6%]) than in the control arm (82 [52.9%]), with a difference between the 2 arms of 39.3% (95% CI, 21.4%-48.9%; P < .001). Regarding the secondary end points, the mean (SD) visual measure of anxiety was lower in the music arm (1.4 [2.0]) than in the control arm (3.1 [2.4]), with a difference of 1.5 (95% CI, 1.0-2.1; P = .005). The mean (SD) number of sedative drug injections required during surgery was 0.04 (0.24) vs 0.54 (0.74) in the music vs control arms, respectively, with a difference of 0.50 (95% CI, 0.43-0.57; P < .001).
Conclusions and Relevance
For participants similar to those enrolled in this study, the trial suggests that a web app–based personalized music intervention before cataract surgery may be considered to lower anxiety levels and hypertension or reduce the need for sedative medication.
ClinicalTrials.gov Identifier: NCT02892825
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Author: Gilles Guerrier, MD, PhD, Hôpital Cochin, Department of Anesthesia and Intensive Care, 27 rue du Faubourg Saint-Jacques, 75014 Paris, France (email@example.com).
Accepted for Publication: February 22, 2021.
Published Online: July 29, 2021. doi:10.1001/jamaophthalmol.2021.2767
Author Contributions: Dr Guerrier had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Guerrier, Abdoul, Rothschild.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Guerrier, Rothschild.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Guerrier, Abdoul, Jilet.
Obtained funding: Guerrier, Abdoul.
Administrative, technical, or material support: Guerrier, Abdoul.
Supervision: Guerrier, Abdoul, Rothschild.
Conflict of Interest Disclosures: None reported.
Funding/Support: The study was funded by a grant from Programme Hospitalier de Recherche Infirmière et Paramédicale (Ministère de la Santé N° AOM A00728-43). The sponsor was Assistance Publique-Hôpitaux de Paris (AP-HP) (Department of Clinical Research and Development) and did not provide any funding.
Role of the Funder/Sponsor: The funder and sponsor played no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 2.
Additional Contributions: The nurses and nursing assistants at the 3 study centers ensured the well-being of the participants. The Clinical Research Unit-Clinical Investigation Center, within hospital support structure dedicated to research that helps and support physicians in carrying out their clinical research projects, contributed in the implementation, monitoring, and data management of the study.
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