Dataset Information

Efficacy of a Web App-Based Music Intervention During Cataract Surgery: A Randomized Clinical Trial.

ABSTRACT:

Importance

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.

Objective

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 a single 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.

Interventions

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.

Results

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.

Trial registration

ClinicalTrials.gov Identifier: NCT02892825.

SUBMITTER: Guerrier G

PROVIDER: S-EPMC8323047 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The aim of the present study was to investigate the impact of preoperative music exposure on intra- and post-operative pain during cataract surgery. This study was conducted alongside a prospective single-masked randomized controlled trial (ClinicalTrials.gov NCT02892825). Patients undergoing first eye cataract surgery were included and randomly assigned to either the intervention or control group. Patients in the intervention group had a 20-min music session through earphones before surgery, while patients in the control group wore earphones without music. Anxiety level evaluated using the visual analog scale and heart rate were collected before and after music intervention. Pain level was assessed using the Numerical Pain Rating Scale, during the surgical procedure, prior to discharge and 7 days postoperatively. A total of 243 patients were included: 119 in the intervention group and 124 in the control group. No significant differences in baseline characteristics, including age, sex and rate of treated hypertension were found between the 2 groups (all p-values > 0.05). In addition, no significantly differences were found in heart rate and anxiety level before music intervention between the 2 groups (all p-values > 0.05). Conversely, anxiety level was significantly lower in the music group after the intervention (respectively, 1.3 ± 1.1 vs 3.2 ± 2.2; p < 0.05). Patients in the music group reported a lower mean pain level during surgical procedure and before discharge compared with control group (respectively, 1.2 ± 0.5 vs 2.1 ± 1.1, p = 0.03 and 0.23 ± 0.4 vs 0.81 ± 0.7, p = 0.04). No difference was found in pain level 7 days postoperatively (0.1 ± 0.3 vs 0.2 ± 0.4, p = 0.1). A significant correlation was found between anxiety level and intraoperative pain level (R = 0.64, p = 0.02). In conclusion, music intervention was effective in reducing anxiety level and self-reported pain both during surgery and in the early postoperative period. Clinical Trial Registration: https://clinicaltrials.gov/ct2/home, identifier NCT02892825.

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