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CompletedNCT05904392Updated Sep 15, 2026

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

An interventional study of Music in Anxiety and Fear, sponsored by Althaia Xarxa Assistencial Universitària de Manresa. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Althaia Xarxa Assistencial Universitària de Manresa · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2023, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anxiety and Fear

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Keywords

  • Music therapy
  • anxiety
  • intravitreal injection
  • pain
  • quality of life
03

In context

Anxiety Disorders Unverified

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Althaia Xarxa Assistencial Universitària de Manresa is the lead sponsor of 21 studies on the registry; 3 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Intervention

    Music played prior to intravitreal injection

    Other: Music

  • No intervention
    Control

    No music played.

Interventions

  • OtherMusic

    Music played prior to injection

06

What researchers measure

Primary outcomes

  1. STAI

    Change in anxiety score test

    Time frame: Just before and immediately after intervention

07

Study locations

1 site
  • Eduard Pedemonte Sarrias
    Manresa, Barcelona 08243, Spain
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2023 to primary completion in Apr 2023, 2 months.

Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 2 months is below that.

Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2023
First posted
Jun 15, 2023
StartActual
Feb 1, 2023
Primary completionActual
Apr 30, 2023
CompletionActual
Apr 30, 2023
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05904392
Lead sponsor
Althaia Xarxa Assistencial Universitària de Manresa
Collaborators
University of Vic - Central University of Catalonia
Responsible party
Eduard Pedemonte-Sarrias (MD, PhD, Althaia Xarxa Assistencial Universitària de Manresa) — Principal investigator
First posted
Jun 15, 2023
Start date
Feb 1, 2023
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023
Last update
Sep 15, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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