AngiographyNCT04316754
Effectiveness of Music During Cardiac Catheterization
A study testing music in people with Angiography, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The research was planned on a randomized controlled experimental basis. Simple stratified randomization will be performed according to gender and age. Consent will be obtained from children and parents who agree to participate in the research. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Angiography
- What is being tested?
- music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2020to 1 Aug 2021
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Volunteering to participate in research
- Being between 7-18 years of age
- Lack of communication problems (vision, hearing, mental)
- Being informed about surgical intervention
- Lack of prior surgical intervention experience
- Receiving sedoanalgesia during angiography
Who cannot join
- Intubation of the child during angiography
- Parent's refusal to take part in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Behcet Uz Children's Hospital
Izmir, 35640
About this study
Official title: Effectiveness of Music During Cardiac Catheterization On Children's Pain, Fear, Anxiety and Vital Signs: A Randomized, Double-Blind Controlled Trial
The research was planned on a randomized controlled experimental basis. Simple stratified randomization will be performed according to gender and age. Consent will be obtained from children and parents who agree to participate in the research.
Before angiography, "Child Fear Scale", "State-Trait Anxiety Scale (STAI-TX)", and "Vital Signs Follow-up Form" will be applied to all children taking part in the study and life signs will be recorded.
Read more
During angiography, the first group will listen to the music that the child wants to listen to. The second group will listen to the music which determined by the researchers. No music will be played to the control group. During angiography (when the child is listening to the music) vital signs will be recorded in 0. min., 1st minute, 5th minute, 10th minute, 15th minute, 30th minute and 60th minute.
"Numerical Pain Scale", "Child Fear Scale", "State Anxiety Scale", and "Vital Signs Follow-up Form" will be re-evaluated to all three groups after angiography.
Read the detailed description
This study was planned to determine the effect of music during angiography on pain, fear, anxiety and life signs in children aged 7-18.
The research was planned on a randomized controlled experimental basis. Simple stratified randomization will be performed according to gender and age. Consent will be obtained from children and parents who agree to participate in the research.
Before angiography, "Child Fear Scale", "State-Trait Anxiety Scale (STAI-TX)", and "Vital Signs Follow-up Form" will be applied to all children taking part in the study and life signs will be recorded.
The sample size of the study was determined and the effect size was 0.25 based on the Standard effect sizes determined by Cohen. In the study, the sample number of 0.84 in the statistical power α=0.05 confidence interval was calculated as 36 for each group.
During angiography, the first group will listen to the music that the child wants to listen to. The second group will listen to the music which determined by the researchers. No music will be played to the control group. During angiography (when the child is listening to the music) vital signs will be recorded in 0. min., 1st minute, 5th minute, 10th minute, 15th minute, 30th minute and 60th minute.
"Numerical Pain Scale", "Child Fear Scale", "State Anxiety Scale", and "Vital Signs Follow-up Form" will be re-evaluated to all three groups after angiography.
- Conditions
- Angiography
- Being tested
- music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
During angiography, the Intervention-1 group will listen to the music that the child wants to listen to. The Intervention-2 group will listen to the "Arts of Fugue" by Bach. No music will be played to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No music will be played to the control group. |
| Intervention 1 | Active comparator | During angiography, the Intervention-1 group will listen to the music that the child wants to listen. Receives: Other: music |
| Intervention-2 | Active comparator | The Intervention-2 group will listen to the music which determined by the researchers. The music which determined by the researchers is "The art of fugue" by Johann Sebastian Bach. The music to be played has been decided by examining the literature. (DOI: 10.4274/jpr.24892) Receives: Other: music |
What is being measured
The primary outcome is the main question the study is designed to answer.
child's heart rate
the child's pulse rate will be measured.
Measured: baseline (at the beginning of angiography)
child's heart rate
the child's pulse rate will be measured.
Measured: 1st minute of the angiography
child's heart rate
the child's pulse rate will be measured.
Measured: 5th minute of the angiography
child's heart rate
the child's pulse rate will be measured.
Measured: 10th minute of the angiography
child's heart rate
the child's pulse rate will be measured.
Measured: 30th minute of the angiography
child's heart rate
the child's pulse rate will be measured.
Measured: 60th minute of the angiography
child's respiratory rate
the child's respiratory rate will be measured.
Measured: Baseline (at the beginning of angiography)
child's respiratory rate
the child's respiratory rate will be measured.
Measured: 1st minute of the angiography
child's respiratory rate
the child's respiratory rate will be measured.
Measured: 5th minute of the angiography
child's respiratory rate
the child's respiratory rate will be measured.
Measured: 10th minute of the angiography
child's respiratory rate
the child's respiratory rate will be measured.
Measured: 15th minute of the angiography
child's respiratory rate
the child's respiratory rate will be measured.
Measured: 30th minute of the angiography
child's respiratory rate
the child's respiratory rate will be measured.
Measured: 60th minute of the angiography
child's blood pressure
the child's blood pressure will be measured.
Measured: baseline (at the beginning of angiography)
child's blood pressure
the child's blood pressure will be measured.
Measured: 1st minute of the angiography
child's blood pressure
the child's blood pressure will be measured.
Measured: 5th minute of the angiography
child's blood pressure
the child's blood pressure will be measured.
Measured: 10th minute of the angiography
child's blood pressure
the child's blood pressure will be measured.
Measured: 15th minute of the angiography
child's blood pressure
the child's blood pressure will be measured.
Measured: 30th minute of the angiography
child's blood pressure
the child's blood pressure will be measured.
Measured: 60th minute of the angiography
child's body temperature
the child's body temperature will be measured.
Measured: Baseline (at the beginning of angiography)
child's body temperature
the child's body temperature will be measured.
Measured: 1st minute of the angiography
child's body temperature
the child's body temperature will be measured.
Measured: 5th minute of the angiography
child's body temperature
the child's body temperature will be measured.
Measured: 10th minute of the angiography
child's body temperature
the child's body temperature will be measured.
Measured: 15th minute of the angiography
child's body temperature
the child's body temperature will be measured.
Measured: 30th minute of the angiography
child's body temperature
the child's body temperature will be measured.
Measured: 60th minute of the angiography
child's oxygen saturation
the child's oxygen saturation will be measured.
Measured: baseline (at the beginning of angiography)
child's oxygen saturation
the child's oxygen saturation will be measured.
Measured: 1st minute of the angiography
child's oxygen saturation
the child's oxygen saturation will be measured.
Measured: 5th minute of the angiography
child's oxygen saturation
the child's oxygen saturation will be measured.
Measured: 10th minute of the angiography
child's oxygen saturation
the child's oxygen saturation will be measured.
Measured: 15th minute of the angiography
child's oxygen saturation
the child's oxygen saturation will be measured.
Measured: 30th minute of the angiography
child's oxygen saturation
the child's oxygen saturation will be measured.
Measured: 60th minute of the angiography
child's fear
Child fear will be assessed by "Children's Fear Scale". This scale includes 5 different facial expressions. This scale is rated from 0-4 and it is stated that it is a reliable and valid measurement tool for the assessment of fear.
Measured: up to 60 min (when the child wakes up from anaesthetic)
child's anxiety
Child anxiety will be assessed by the "State Anxiety Scale". This scale includes 5 different facial expressions. The children are expected to evaluate how they feel at the moment. Expressions such as "I feel very angry", "I feel angry or" I do not feel angry "are asked to mark the most appropriate one for them.
The total number of items is 20. The lowest score is 20, the highest the score is 60.
Measured: up to 60 min (when the child wakes up from anaesthetic)
child's pain
Child pain will be assessed by the " Numeric Pain Scale". This method is intended to determine the severity of pain and to explain the patient's pain in numbers. On numerical scales, it starts with the absence of pain (0) and reaches the level of unbearable pain (10).
Measured: up to 60 min (when the child wakes up from anaesthetic)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start20 Mar 2020
- Primary completion15 Apr 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AngiographyStudies 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
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Behcet Uz Children's Hospital
- Responsible party
- Principal investigator, ESRA ARDAHAN AKGUL, Izmir Katip Celebi University
- Investigators
- Timur MEŞE, prof., Study director, Ministry of Health- İzmir Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316754
- Sponsor's protocol ID
- 2019/369
- Status last verified
- Dec 2021
- First submitted
- 9 Mar 2020
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karakul A, Akgul EA, Yaliniz R, Mese T. Effectiveness of music during cardiac catheterization on children's pain, fear, anxiety and vital signs: A randomized, blind controlled trial. J Pediatr Nurs. 2022 Jul-Aug;65:e56-e62. doi: 10.1016/j.pedn.2022.02.009. Epub 2022 Mar 10.
PubMed 35279331
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Music During Cardiac Catheterization On Children's Pain, Fear, Anxiety and Vital Signs: A Randomized, Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT04316754
- Acronym / sponsor ID
- 2019/369
- Conditions
- Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Dr. Behcet Uz Children's Hospital
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 20 Mar 2020 (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 research was planned on a randomized controlled experimental basis. Simple stratified randomization will be performed according to gender and age. Consent will be obtained from children and parents who agree to participate in the research.
Before angiography, "Child Fear Scale", "State-Trait Anxiety Scale (STAI-TX)", and "Vital Signs Follow-up Form" will be applied to all children taking part in the study and life signs will be recorded.
During angiography, the first group will listen to the music that the child wants to listen to. The second group will listen to the music which determined by the researchers. No music will be played to the control group. During angiography (when the child is listening to the music) vital signs will be recorded in 0. min., 1st minute, 5th minute, 10th minute, 15th minute, 30th minute and 60th minute.
"Numerical Pain Scale", "Child Fear Scale", "State Anxiety Scale", and "Vital Signs Follow-up Form" will be re-evaluated to all three groups after angiography.
Detailed description
This study was planned to determine the effect of music during angiography on pain, fear, anxiety and life signs in children aged 7-18.
The research was planned on a randomized controlled experimental basis. Simple stratified randomization will be performed according to gender and age. Consent will be obtained from children and parents who agree to participate in the research.
Before angiography, "Child Fear Scale", "State-Trait Anxiety Scale (STAI-TX)", and "Vital Signs Follow-up Form" will be applied to all children taking part in the study and life signs will be recorded.
The sample size of the study was determined and the effect size was 0.25 based on the Standard effect sizes determined by Cohen. In the study, the sample number of 0.84 in the statistical power α=0.05 confidence interval was calculated as 36 for each group.
During angiography, the first group will listen to the music that the child wants to listen to. The second group will listen to the music which determined by the researchers. No music will be played to the control group. During angiography (when the child is listening to the music) vital signs will be recorded in 0. min., 1st minute, 5th minute, 10th minute, 15th minute, 30th minute and 60th minute.
"Numerical Pain Scale", "Child Fear Scale", "State Anxiety Scale", and "Vital Signs Follow-up Form" will be re-evaluated to all three groups after angiography.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No music will be played to the control group. |
| Intervention 1 | Active comparator | Other: musicDuring angiography, the Intervention-1 group will listen to the music that the child wants to listen. |
| Intervention-2 | Active comparator | Other: musicThe Intervention-2 group will listen to the music which determined by the researchers. The music which determined by the researchers is "The art of fugue" by Johann Sebastian Bach. The music to be played has been decided by examining the literature. (DOI: 10.4274/jpr.24892) |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Volunteering to participate in research
- Being between 7-18 years of age
- Lack of communication problems (vision, hearing, mental)
- Being informed about surgical intervention
- Lack of prior surgical intervention experience
Key exclusion criteria (2 listed)
- Intubation of the child during angiography
- Parent's refusal to take part in the study
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 |
|---|---|---|
| musicDuring angiography, the Intervention-1 group will listen to the music that the child wants to listen to. The Intervention-2 group will listen to the "Arts of Fugue" by Bach. No music will be played to the control group. | Other | Intervention 1, Intervention-2 |
Primary outcome
child's heart rate
Time frame: baseline (at the beginning of angiography)
the child's pulse rate will be measured.
child's heart rate
Time frame: 1st minute of the angiography
the child's pulse rate will be measured.
child's heart rate
Time frame: 5th minute of the angiography
the child's pulse rate will be measured.
child's heart rate
Time frame: 10th minute of the angiography
the child's pulse rate will be measured.
child's heart rate
Time frame: 30th minute of the angiography
the child's pulse rate will be measured.
child's heart rate
Time frame: 60th minute of the angiography
the child's pulse rate will be measured.
child's respiratory rate
Time frame: Baseline (at the beginning of angiography)
the child's respiratory rate will be measured.
child's respiratory rate
Time frame: 1st minute of the angiography
the child's respiratory rate will be measured.
child's respiratory rate
Time frame: 5th minute of the angiography
the child's respiratory rate will be measured.
child's respiratory rate
Time frame: 10th minute of the angiography
the child's respiratory rate will be measured.
child's respiratory rate
Time frame: 15th minute of the angiography
the child's respiratory rate will be measured.
child's respiratory rate
Time frame: 30th minute of the angiography
the child's respiratory rate will be measured.
child's respiratory rate
Time frame: 60th minute of the angiography
the child's respiratory rate will be measured.
child's blood pressure
Time frame: baseline (at the beginning of angiography)
the child's blood pressure will be measured.
child's blood pressure
Time frame: 1st minute of the angiography
the child's blood pressure will be measured.
child's blood pressure
Time frame: 5th minute of the angiography
the child's blood pressure will be measured.
child's blood pressure
Time frame: 10th minute of the angiography
the child's blood pressure will be measured.
child's blood pressure
Time frame: 15th minute of the angiography
the child's blood pressure will be measured.
child's blood pressure
Time frame: 30th minute of the angiography
the child's blood pressure will be measured.
child's blood pressure
Time frame: 60th minute of the angiography
the child's blood pressure will be measured.
child's body temperature
Time frame: Baseline (at the beginning of angiography)
the child's body temperature will be measured.
child's body temperature
Time frame: 1st minute of the angiography
the child's body temperature will be measured.
child's body temperature
Time frame: 5th minute of the angiography
the child's body temperature will be measured.
child's body temperature
Time frame: 10th minute of the angiography
the child's body temperature will be measured.
child's body temperature
Time frame: 15th minute of the angiography
the child's body temperature will be measured.
child's body temperature
Time frame: 30th minute of the angiography
the child's body temperature will be measured.
child's body temperature
Time frame: 60th minute of the angiography
the child's body temperature will be measured.
child's oxygen saturation
Time frame: baseline (at the beginning of angiography)
the child's oxygen saturation will be measured.
child's oxygen saturation
Time frame: 1st minute of the angiography
the child's oxygen saturation will be measured.
child's oxygen saturation
Time frame: 5th minute of the angiography
the child's oxygen saturation will be measured.
child's oxygen saturation
Time frame: 10th minute of the angiography
the child's oxygen saturation will be measured.
child's oxygen saturation
Time frame: 15th minute of the angiography
the child's oxygen saturation will be measured.
child's oxygen saturation
Time frame: 30th minute of the angiography
the child's oxygen saturation will be measured.
child's oxygen saturation
Time frame: 60th minute of the angiography
the child's oxygen saturation will be measured.
child's fear
Time frame: up to 60 min (when the child wakes up from anaesthetic)
Child fear will be assessed by "Children's Fear Scale". This scale includes 5 different facial expressions. This scale is rated from 0-4 and it is stated that it is a reliable and valid measurement tool for the assessment of fear.
child's anxiety
Time frame: up to 60 min (when the child wakes up from anaesthetic)
Child anxiety will be assessed by the "State Anxiety Scale". This scale includes 5 different facial expressions. The children are expected to evaluate how they feel at the moment. Expressions such as "I feel very angry", "I feel angry or" I do not feel angry "are asked to mark the most appropriate one for them. The total number of items is 20. The lowest score is 20, the highest the score is 60.
child's pain
Time frame: up to 60 min (when the child wakes up from anaesthetic)
Child pain will be assessed by the " Numeric Pain Scale". This method is intended to determine the severity of pain and to explain the patient's pain in numbers. On numerical scales, it starts with the absence of pain (0) and reaches the level of unbearable pain (10).
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 30 Dec 2021.
- Derived from this study: PubMed 35279331Karakul A, Akgul EA, Yaliniz R, Mese T. Effectiveness of music during cardiac catheterization on children's pain, fear, anxiety and vital signs: A randomized, blind controlled trial. J Pediatr Nurs. 2022 Jul-Aug;65:e56-e62. doi: 10.1016/j.pedn.2022.02.009. Epub 2022 Mar 10.
Related trials for Angiography
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
Computed Tomography Angiography, Coronary Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
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.
Timur MEŞE, prof. study director
Ministry of Health- İzmir Turkey
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 Angiography, run by Izmir Katip Celebi 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 6 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 30 Dec 2021. 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?
child's heart rate (time frame: baseline (at the beginning of angiography)). The study lists 37 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04316754, which also lists 1 linked publication.
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 30 Dec 2021.