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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05904392
Enrollment
50
Registered
2023-06-15
Start date
2023-02-01
Completion date
2023-04-30
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety and Fear

Keywords

Music therapy, anxiety, intravitreal injection, pain, quality of life

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.

Interventions

OTHERMusic

Music played prior to injection

Sponsors

Althaia Xarxa Assistencial Universitària de Manresa
Lead SponsorOTHER
University of Vic - Central University of Catalonia
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
STAIJust before and immediately after interventionChange in anxiety score test

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026