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

NCT ID: NCT05904392

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-02-28

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.

Conditions

Anxiety and Fear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Music played prior to intravitreal injection

Group Type: EXPERIMENTAL

Music

Intervention Type: OTHER

Music played prior to injection

Control

No music played.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music

Music played prior to injection

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vic - Central University of Catalonia

OTHER

Sponsor Role: collaborator

Althaia Xarxa Assistencial Universitària de Manresa

OTHER

Sponsor Role: lead

Responsible Party

Eduard Pedemonte-Sarrias

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eduard Pedemonte Sarrias

Manresa, Barcelona, Spain

Countries

Spain

Other Identifiers

CEI 22/109

Identifier Type: -

Identifier Source: org_study_id