Impact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia

Anxiety Clinical Trial

Official title:

Impact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04819750
• Other study ID #: MUSICOTOPICAT
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: University of Liege
• Contact: Benjamin Javillier, MD
• Phone: 042843820
• Email: javillier.benjamin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cataract surgery with topic anesthesia is anxiety provoking. This operative stress can increase pain perception and blood pressure. This discomfort can lead to non-compliance with immobility and potentially lead to intraoperative and postoperative complications.

Pharmacological means are limited to reduce anxiety. Only anxiolytics could be effective but at the cost of side effects not compatible with surgery.

Music Care is a "digital treatment" allowing the diffusion of music with a U-shaped sequence using the principles of hypnoanalgesia.

The objective of this study is to evaluate the effectiveness of the MusicCare listening device on the anxiety of patients during cataract surgery with topic anesthesia

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cataract surgery with topical anesthesia

Exclusion Criteria:

• Hearing impaired patient

Related Conditions & MeSH terms

• Anxiety
• Cataract

Intervention

Device:
• MusicCare® device
The device is a touch tablet with a headset that allows noise reduction. The patient can choose the music they prefer. The selected U-shaped sequence uses the principles of hypnoanalgesia to accompany the patient into a state of deep relaxation.
• Headphones with noise reduction
Headphones with noise reduction without music

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-assessed anxiety score between the 2 groups	Self-assessed anxiety score on a visual analogue scale (VAS) from 0 to 10 (0 means no anxiety and 10 the maximum anxiety)	Baseline day, when entering the operating room
Secondary	Self-assessment of the duration of the surgery	Self-rated duration of surgery on a scale of 0 to 5 (0 means 5 to 10 minutes and 5 means 25 to 30 minutes)	Baseline day, when entering the operating room