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

Primary Purpose

Anxiety and Fear

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Music
Sponsored by
Althaia Xarxa Assistencial Universitària de Manresa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety and Fear focused on measuring Music therapy, anxiety, intravitreal injection, pain, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eduard Pedemonte Sarrias

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Music played prior to intravitreal injection

No music played.

Outcomes

Primary Outcome Measures

STAI
Change in anxiety score test

Secondary Outcome Measures

Full Information

First Posted
May 28, 2023
Last Updated
September 12, 2023
Sponsor
Althaia Xarxa Assistencial Universitària de Manresa
Collaborators
University of Vic - Central University of Catalonia
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1. Study Identification

Unique Protocol Identification Number
NCT05904392
Brief Title
Effect of Music Therapy on the Anxiety Level of Patients During the Administration of Ocular Intravitreal Injections
Official Title
Effect of Music Therapy on the Anxiety Level of Patients During the Administration of Ocular Intravitreal Injections
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Althaia Xarxa Assistencial Universitària de Manresa
Collaborators
University of Vic - Central University of Catalonia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety and Fear
Keywords
Music therapy, anxiety, intravitreal injection, pain, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Music played prior to intravitreal injection
Arm Title
Control
Arm Type
No Intervention
Arm Description
No music played.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
Music played prior to injection
Primary Outcome Measure Information:
Title
STAI
Description
Change in anxiety score test
Time Frame
Just before and immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Eduard Pedemonte Sarrias
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain

12. IPD Sharing Statement

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

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