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

Sponsor

Althaia Xarxa Assistencial Universitària de Manresa (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05904392

Collaborator

University of Vic - Central University of Catalonia (Other)

Enrollment

Location

Arms

6.3

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety and Fear	Other: Music	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 1, 2022

Actual Primary Completion Date :

Apr 26, 2023

Anticipated Study Completion Date :

Jun 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Music played prior to intravitreal injection	Other: Music Music played prior to injection
No Intervention: Control No music played.

Arm

Intervention/Treatment

Experimental: Intervention

Music played prior to intravitreal injection

Other: Music

Music played prior to injection

No Intervention: Control

No music played.

Outcome Measures

Primary Outcome Measures

STAI [Just before and immediately after intervention]
Change in anxiety score test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.