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

Anxiety and Fear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05904392
• Other study ID #: CEI 22/109
• Status: Completed
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2024
• Source: Althaia Xarxa Assistencial Universitària de Manresa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 28, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety and Fear
• Anxiety Disorders

Intervention

Other:
• Music
Music played prior to injection

Locations

Country	Name	City	State
Spain	Eduard Pedemonte Sarrias	Manresa	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Althaia Xarxa Assistencial Universitària de Manresa	University of Vic - Central University of Catalonia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	STAI	Change in anxiety score test	Just before and immediately after intervention