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

NCT05904392 | Completed

• 1 other identifier: CEI 22/109
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• STAI

  Change in anxiety score test

  Just before and immediately after intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Music played prior to intravitreal injection

Other: Music

Control

NO INTERVENTION

No music played.

Interventions

Music OTHER

Music played prior to injection

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Althaia Xarxa Assistencial Universitària de Manresa: lead
• University of Vic - Central University of Catalonia: collaborator

Study Sites (1)

Eduard Pedemonte Sarrias

Manresa, Barcelona, 08243, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: June 15, 2023
• Study Start: December 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: February 28, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

ES (1)