Music InterventionNCT04212338
Effect of Music Intervention on Intravitreal Injection
A study testing Before intravitreal injection music intervention and during intravitreal injection music intervention in people with Music Intervention, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study was to examine the effect of music intervention in the before-intravitreal injection (IVTI) and during-IVTI periods on patients' anxiety, the sensation of pain, physiological variables, satisfaction, and surgeon-patient cooperation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Music Intervention
- What is being tested?
- Before intravitreal injection music intervention and during intravitreal injection music intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2019to 24 May 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participants were patients aged 18 or above,
- Who did not have a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had not received a diagnosis of depression, who volunteered to participate in the study, and on whom elective IVTI was carried out, or who had undergone IVTI previously.
Who cannot join
- The participants were patients aged under 18 years
- Who had a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had received a diagnosis of depression, who did not volunteered to participate in the study, and or who had not undergone IVTI previously.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Science University
Afyonkarahisar, Centre, 03200
About this study
Official title: Effect of Music Intervention on Pain, Anxiety, Physiological Variables, Patient Satisfaction, and Surgeon-Patient Cooperation in Intravitreal Injection
The objective of this study was to examine the effect of music intervention in the before-intravitreal injection (IVTI) and during-IVTI periods on patients' anxiety, the sensation of pain, physiological variables, satisfaction, and surgeon-patient cooperation. The study used a randomized controlled experimental design. The study was conducted with a total of three groups: two experimental (Before-IVTI (Group1) and During-IVTI music intervention group (Group 2)) and one control group. Each of the experimental and control groups consisted of 75 patients. The patients' anxiety was evaluated using the VAS anxiety scale, pain using the VAS pain scale; surgeon-patient cooperation using the Numeric Rating Scale; and patient satisfaction with a 5-point likert-type satisfaction scale.
- Conditions
- Music Intervention
- Being tested
- Before intravitreal injection music intervention, during intravitreal injection music intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Before intravitreal injection music interventionOther
The patients in the Before-IVTI group listened to music for a period of 15 minutes 30 minutes before the injection.
during intravitreal injection music interventionOther
The patients in the During-IVTI group listened to music during the injection (approximately 5 minutes).
| Study group | Role | What they receive |
|---|---|---|
| study group 1 | Experimental | Before intravitreal injection music intervention: These patients received the standard treatment and listened to music for a period of 15 minutes 30 minutes before the injection. Receives: Other: Before intravitreal injection music intervention |
| study group 2 | Experimental | During-intravitreal injection music intervention:These patients received the standard treatment and listened to music during the injection (approximately 5 minutes). Receives: Other: during intravitreal injection music intervention |
| control group | No intervention | The music intervention was not conducted with the patients in the control group. These patients received the standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale for Anxiety (VAS-A)
VAS-A is a measurement tool, in which 0 represents feeling "no anxiety" while 10 represents "I feel extremely anxious".29 An increase in score indicates an increase in the anxiety experienced by the patient. This indicates that VAS-A is a reliable and accurate measurement tool despite its brevity. The VAS-A scale was applied to patients before, immediately after, and 15 minutes after the injection.
Measured: 1 day
Secondary outcomes (1)
Visual Analog Scale for Pain (VAS)
VAS scale is a single-dimensional scale that is commonly used to evaluate pain severity. According to the VAS, pain severity is rated from 0 (no pain) to 10 (the greatest imaginable pain). Any score under 3 on the scale is considered "mild pain", scores between 3 and 6 are "moderate pain" and any score above 6 is "severe pain". The VAS was applied both immediately after the injection and 15 minutes afterwards in order to determine the severity of the pain that the patients felt during the injection.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start11 Mar 2019
- Primary completion24 May 2019
- Study completion24 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music InterventionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Ciğerci, Afyonkarahisar Health Sciences University
- Investigators
- Yeliz Ciğerci, Principal investigator, +90 272 444 0304
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212338
- Sponsor's protocol ID
- 2019/76
- Status last verified
- Dec 2019
- First submitted
- 24 Dec 2019
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Intervention on Pain, Anxiety, Physiological Variables, Patient Satisfaction, and Surgeon-Patient Cooperation in Intravitreal Injection
- ClinicalTrials.gov ID
- NCT04212338
- Acronym / sponsor ID
- 2019/76
- Conditions
- Music Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 27 Dec 2019 (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.
The objective of this study was to examine the effect of music intervention in the before-intravitreal injection (IVTI) and during-IVTI periods on patients' anxiety, the sensation of pain, physiological variables, satisfaction, and surgeon-patient cooperation. The study used a randomized controlled experimental design. The study was conducted with a total of three groups: two experimental (Before-IVTI (Group1) and During-IVTI music intervention group (Group 2)) and one control group. Each of the experimental and control groups consisted of 75 patients. The patients' anxiety was evaluated using the VAS anxiety scale, pain using the VAS pain scale; surgeon-patient cooperation using the Numeric Rating Scale; and patient satisfaction with a 5-point likert-type satisfaction scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| study group 1 | Experimental | Other: Before intravitreal injection music interventionBefore intravitreal injection music intervention: These patients received the standard treatment and listened to music for a period of 15 minutes 30 minutes before the injection. |
| study group 2 | Experimental | Other: during intravitreal injection music interventionDuring-intravitreal injection music intervention:These patients received the standard treatment and listened to music during the injection (approximately 5 minutes). |
| control group | No intervention | –The music intervention was not conducted with the patients in the control group. These patients received the standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The participants were patients aged 18 or above,
- Who did not have a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had not received a diagnosis of depression, who volunteered to participate in the study, and on whom elective IVTI was carried out, or who had undergone IVTI previously.
Key exclusion criteria (2 listed)
- The participants were patients aged under 18 years
- Who had a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had received a diagnosis of depression, who did not volunteered to participate in the study, and or who had not undergone IVTI previously.
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 |
|---|---|---|
| Before intravitreal injection music interventionThe patients in the Before-IVTI group listened to music for a period of 15 minutes 30 minutes before the injection. | Other | study group 1 |
| during intravitreal injection music interventionThe patients in the During-IVTI group listened to music during the injection (approximately 5 minutes). | Other | study group 2 |
Primary outcome
Visual Analog Scale for Anxiety (VAS-A)
Time frame: 1 day
VAS-A is a measurement tool, in which 0 represents feeling "no anxiety" while 10 represents "I feel extremely anxious".29 An increase in score indicates an increase in the anxiety experienced by the patient. This indicates that VAS-A is a reliable and accurate measurement tool despite its brevity. The VAS-A scale was applied to patients before, immediately after, and 15 minutes after the injection.
1 secondary outcome
Visual Analog Scale for Pain (VAS)
Time frame: 1 day
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 27 Dec 2019.
Related trials for Music Intervention
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Perioperative Meditation Music Intervention in Patients With Type 2 Diabetes Undergoing Elective Surgery
Diabetes Type 2
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Musical Intervention for Dental Anxiety
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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.
Yeliz Ciğerci principal investigator
+90 272 444 0304
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Before intravitreal injection music intervention and during intravitreal injection music intervention in people with Music Intervention, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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 27 Dec 2019. 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 Turkey (Türkiye). 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?
Visual Analog Scale for Anxiety (VAS-A) (time frame: 1 day). 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 27 Dec 2019.