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

A

Althaia Xarxa Assistencial Universitària de Manresa

Status

Completed

Conditions

Anxiety and Fear

Treatments

Other: Music

Study type

Interventional

Funder types

Other

Identifiers

NCT05904392
CEI 22/109

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Intervention
Experimental group
Description:
Music played prior to intravitreal injection
Treatment:
Other: Music
Control
No Intervention group
Description:
No music played.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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