Anxiety and FearNCT05904392
Effect of Music Therapy on the Anxiety Level of Patients During the Administration of Ocular Intravitreal Injections
A study testing Music in people with Anxiety and Fear, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety and Fear
- What is being tested?
- Music
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Music
- Keywords
- Music therapy, anxiety, intravitreal injection, pain, quality of life
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Music played prior to injection
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Music played prior to intravitreal injection Receives: Other: Music |
| Control | No intervention | No music played. |
What is being measured
The primary outcome is the main question the study is designed to answer.
STAI
Change in anxiety score test
Measured: Just before and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Feb 2023
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vic - Central University of Catalonia
- Responsible party
- Principal investigator, Eduard Pedemonte-Sarrias, Althaia Xarxa Assistencial Universitària de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904392
- Sponsor's protocol ID
- CEI 22/109
- Status last verified
- Mar 2024
- First submitted
- 28 May 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Therapy on the Anxiety Level of Patients During the Administration of Ocular Intravitreal Injections
- ClinicalTrials.gov ID
- NCT05904392
- Acronym / sponsor ID
- CEI 22/109
- Conditions
- Anxiety and Fear
- Keywords
- Music therapy, anxiety, intravitreal injection, pain, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de ManresaUniversity, hospital or other
- Collaborators
- University of Vic - Central University of Catalonia
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: MusicMusic played prior to intravitreal injection |
| Control | No intervention | –No music played. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicMusic played prior to injection | Other | Intervention |
Primary outcome
STAI
Time frame: Just before and immediately after intervention
Change in anxiety score test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
Related trials for Anxiety and Fear
Recruiting
Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis
Knee Osteoarthritis
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Coloring Activity Applied During Labor in Primiparous Pregnant Women and Its Effect on Birth Anxiety and Fear of Childbirth
Fear of Childbirth, Mandala Coloring
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 2
Psilocybin FCR Early-Stage Breast Cancer
Early-stage Breast Cancer, Fear of Cancer Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Anxiety and Fear, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STAI (time frame: Just before and immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.