Skip to main content
OpenTrials
Completed

NCT Number: NCT06230029

Music's Impact on Preoperative Anxiety: Heart Rate Variability Study During Cataract Surgery

The goal of this Randomized Controlled Trial is to evaluate heart rate variability (HRV)before and after listening to music in patients scheduled for cataract surgery under topical anesthesia, compared to patients who do not listen to music. Our hypothesis is that the anxious population with a low HRV benefits from an anxiolytic effect of music to increase HRV levels.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Cataract Surgery Heart Rate Variability Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Cochin/Port-Royal, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • information and consent of the patient,
  • age greater than or equal to 18 years,
  • affiliation to a social security system,
  • benefiting from non-emergency ambulatory cataract surgery under topical anesthesia
  • not being under legal protection.

Exclusion criteria

  • Refusal to participate,
  • language barriers that are incompatible with a reliable assessment
  • use of beta-blockers, including eye drops
  • use of adrenergic, antiadrenergic, cholinergic and anticholinergic drugs
  • use of psychotropic drugs, anxiolytics.

Treatment and study plan

Music listening

Other

Music will be played through individual headphones (BOSE AE2®). The headphones give the impression of personalized music that only the patient can hear. Patients will have a mask over their eyes to limit visual aggression. The songs will be pre-recorded on a digital tablet (Samsung Galaxy®) allowing the broadcasting of music programs. Patients will have the choice to listen to a song according to their musical preferences among 16 different musical styles. The volume will be adapted to the level that suits the patient.

Primary outcomes

  1. Comparison of heart rate variability before vs after listening to music in patients scheduled for cataract surgery under topical anesthesia.

    Time frame: Baseline vs pre-surgery

    Use of a non-invasive sensor: recording chest belt

Secondary outcomes

  1. Evaluation of the impact of music on the incidence of surgical complications

    Time frame: Immediately after the surgery

    Incidence of posterior capsular rupture

  2. Measurement of subjective anxiety level

    Time frame: Before surgery

    Surgical Fear Questionnaire (SFQ): The questionnaire consists of 8 questions (items). The Items 1-4 refer to the subscale 'fear of short term consequences of surgery', the items 5-8 refer to the subscale 'fear of long term consequences of surgery'. All items are scored on an eleven point numeric rating scale (NRS) ranging from 0 (not at all afraid) to 10 (very afraid). This results in a total score of 0 to 80, calculated by summing item 1-8.

  3. Measurement of subjective anxiety level

    Time frame: Before surgery

    Visual Analogue scale (VAS).

    In this 5-score system, we employ illustrative facial expressions to represent varying degrees of anxiety. Each segment is paired with a distinct face, visually conveying the corresponding level of anxiety:

    • No Anxiety: The initial segment features a face showing calmness, symbolizing absence of anxiety.
    • Mild Anxiety: The second segment depicts a face with a slightly concerned expression, indicative of mild anxiety.
    • Moderate Anxiety: In the third segment, the face exhibits clear signs of worry, corresponding to moderate anxiety.
    • Severe Anxiety: The fourth segment portrays a face with a deeply troubled expression, denoting severe anxiety.
    • Extreme Anxiety: The final segment illustrates a face overwhelmed with distress, representing extreme or unbearable anxiety.

    Patients are invited to select the face that best aligns with their current perceived level of anxiety, enabling a more relatable and empathetic approach to self-assessment.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Other

Registry information

Official study title

Impact of Music on Preoperative Anxiety Level Measured by Heart Rate Variability During Cataract Surgery

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.