Music Listening for Cataract Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-02

Study Completion Date

2018-07-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Anxiety in Cataract Patients Using Preoperative Music Therapy

NCT07296731

Cataract Music Therapy

ACTIVE_NOT_RECRUITING NA

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

NCT04819750

Cataract Anxiety

UNKNOWN NA

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

NCT06230029

Anxiety Cataract Surgery Heart Rate Variability

COMPLETED NA

The Effects of Music on Perioperative Outcomes in Cataract Surgery

NCT03873454

Cataract Surgery Stress Levels Music Improving Outcomes in Cataract Surgery

COMPLETED NA

Impact of Music Added to the Usual Treatment on the Anxiety of Patients Undergoing Outpatient Cataract Surgery With Topical Anesthesia

NCT04781231

Cataract Surgery Anxiety

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

music group

music listening

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

headphones with music

no music group

no music listening

Group Type ACTIVE_COMPARATOR

No Music

Intervention Type OTHER

headphones without music

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Music

headphones with music

Intervention Type OTHER

No Music

headphones without music

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing elective cataract surgery performed under topical anaesthesia

Exclusion Criteria

* Non topical anaesthesia
* Non ambulatory surgery
* Communication difficulties including language barrier, and mental disorders
* Age\<18yo
* Hearing impairment
* Uncontrolled hypertension

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No