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OpenTrials
Completed

NCT Number: NCT05904392

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eduard Pedemonte Sarrias

Manresa, Barcelona, 08243, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music

Other

Music played prior to injection

Primary outcomes

  1. STAI

    Time frame: Just before and immediately after intervention

    Change in anxiety score test

Sponsors and collaborators

Lead sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Other

Collaborators

  • University of Vic - Central University of Catalonia

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2023
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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