Effect of Music Therapy on the Anxiety Level of Patients During the Administration of Ocular Intravitreal Injections

Not Applicable

Completed

• Conditions: Anxiety and Fear
• Interventions: Other: Music

• Registration Number: NCT05904392
• Lead Sponsor: Althaia Xarxa Assistencial Universitària de Manresa

Brief Summary

Introduction Ocular intravitreal injection is a widely used ophthalmic invasive technique to administer medication directly inside the patient's eye. Despite being usually a quick and painless intervention, some patients report nervousness and anxiety before and during the procedure. Music therapy could help in assessing this discomfort, as previous studies have shown it can beneficial, specially helping to reduce anxiety levels.

Objective This study aims to assess the effect of music therapy on patients undergoing intravitreal injections and how it affects their anxiety.

Methods This is a randomized, prospective, single blind, clinical trial. Patients will be divided into two groups. Group A patients will listen to classical music during the procedure (intervention). Group B patients (control), will not listen to music during the procedure. All other aspects of the procedure will be the same for both groups. To analyze the impact music therapy, patients will fill in the STAI anxiety questionnaire and will be evaluated with the pain visual analogue scale (VAS) before and after the injection procedure.

Expected results Subjects that undergo the procedure with music therapy are expected to experience less anxiety that the ones that do not. Less pain perception is also expected.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-28
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Study Start: 2023-12-01
• Primary Completion: 2024-01-31
• Study Completion: 2024-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients must be at least 18 years old.
• Patients must have been prescribed an intravitreal injections of an anti-VEGF drug.
• Subjects must have undergone at least one previous intravitreal injection.
• Patients must fully understand the procedure and the project they will be participating in and agree on signing the informed consent.

Exclusion Criteria

• Patients with a psychiatric diagnosis with the need to take anxiety medication.
• Patients that before the intervention took medication to relax, such as benzodiazepines or anxiolytics.
• Subjects with hearing difficulty.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Music	Music played prior to intravitreal injection

Primary Outcome Measures

Name	Time	Method
STAI	Just before and immediately after intervention	Change in anxiety score test

Trial Locations

Locations (1)

Eduard Pedemonte Sarrias; 🇪🇸 Manresa, Barcelona, Spain