FearNCT06086509
Letting Children Listen to Music During Computed Tomography
A study testing Music in people with Fear and Computed Tomography, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
Trial summary
This study examines the effect of music during computed tomography in children. This study, conducted on a total of 60 children, was divided into two groups: the music group and the control group. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear, Computed Tomography
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2023to 20 Sep 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being between the ages of 5-10
- Hospitalization is for diagnostic or treatment purposes
- The child and the parent speak and understand Turkish comfortably.
Who cannot join
- Having previous tomography shooting experience
- Having chronic diseases
- Visual, auditory, speech and mental disorders
- There is a history of sedative, analgesic or narcotic substance use within 24 hours before application.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Music on Fear and Anxiety in Children During Tomography: Randomized Controlled Double-Blind Study
This study examines the effect of music during computed tomography in children. This study, conducted on a total of 60 children, was divided into two groups: the music group and the control group. According to the research results; showed that music reduces fear and anxiety levels in children and stabilizes vital signs (pulse and respiratory rate) during a tomography scan.
Read the detailed description
Aim: This research was conducted to determine the effect of music played during computerized tomography (CT) imaging in children on fear, anxiety and vital signs.
Method: This randomized, double-blind controlled trial was conducted with Consolidated Standards of Reporting Studies (CONSORT) guidelines. The sample includes children aged 5-10 years who had CT scans in the emergency department of a public hospital in eastern Turkey between April 18 and May 20, 2023 and met the inclusion criteria for the study. The research was completed with a total of 60 children, divided evenly into one of two groups. The nursing intervention of the research is to listen to music. Data were collected through face-to-face interviews using the Child and Family Information Form, the Child Fear Scale, the State Anxiety Scale for Children, and the Vital Signs Monitoring Form (pulse, blood pressure, and oxygen saturation). Ethical principles were followed in the research.
- Conditions
- Fear, Computed Tomography
- Being tested
- Music
- Keywords
- Child, Music, Anxiety, Fear
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Children were played music during computerized tomography.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Questionnaires and scales were filled out by the researcher five minutes before the CT scan. Routine CT scans were performed on the control group without listening to music by wearing a Bluetooth headset. The scales were repeated five minutes after the CT scan. |
| music group | Experimental | Questionnaires and scales were filled out by the researcher five minutes before the CT scan. Just before the CT scan began, the children in the music group were started to listen to "Lullaby K 350" music by inserting a Bluetooth headset into their ears. If the process took longer, the music was played again. Additionally, the Bluetooth headset was properly disinfected before each use to prevent the spread of infectious diseases among patients. Receives: Other: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Fear Scale (CFS)
Children's Fear Scale is a scale scored between 0 and 4 showing five faces varying between a neutral expression (0 = no fear) to fearful face (4 = extreme fear).
Measured: one month
Secondary outcomes (1)
Child Anxiety Scale-State (CAS-S)
The Child Anxiety Scale-State Scale resembles a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. This scale, for children ages 4 to 10, instructs children to "Imagine that all your anxious or nervous feelings are in the bulb or bottom part of the thermometer
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start18 Apr 2023
- Primary completion20 May 2023
- Study completion20 Sep 2023
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- They were divided into two groups: control group and experimental group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gümüşhane Universıty
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Demir, Gümüşhane Universıty
- Investigators
- Fatma KURUDİREK, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086509
- Sponsor's protocol ID
- A/BU-HEM-ZDİ-01
- Status last verified
- Oct 2023
- First submitted
- 30 Sep 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kurudirek F, Demir Barbak Z, Demir Imamoglu Z, Ciftci K, Delice O. The Effect of Music on Fear and Anxiety of Children During Tomography: A Randomized Controlled Double-Blind Study. Int J Nurs Pract. 2025 Jun;31(3):e70029. doi: 10.1111/ijn.70029.
PubMed 40511812
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music on Fear and Anxiety in Children During Tomography: Randomized Controlled Double-Blind Study
- ClinicalTrials.gov ID
- NCT06086509
- Acronym / sponsor ID
- A/BU-HEM-ZDİ-01
- Conditions
- Fear, Computed Tomography
- Keywords
- Child, Music, Anxiety, Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gümüşhane UniversıtyUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 17 Oct 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.
This study examines the effect of music during computed tomography in children. This study, conducted on a total of 60 children, was divided into two groups: the music group and the control group. According to the research results; showed that music reduces fear and anxiety levels in children and stabilizes vital signs (pulse and respiratory rate) during a tomography scan.
Detailed description
Aim: This research was conducted to determine the effect of music played during computerized tomography (CT) imaging in children on fear, anxiety and vital signs.
Method: This randomized, double-blind controlled trial was conducted with Consolidated Standards of Reporting Studies (CONSORT) guidelines. The sample includes children aged 5-10 years who had CT scans in the emergency department of a public hospital in eastern Turkey between April 18 and May 20, 2023 and met the inclusion criteria for the study. The research was completed with a total of 60 children, divided evenly into one of two groups. The nursing intervention of the research is to listen to music. Data were collected through face-to-face interviews using the Child and Family Information Form, the Child Fear Scale, the State Anxiety Scale for Children, and the Vital Signs Monitoring Form (pulse, blood pressure, and oxygen saturation). Ethical principles were followed in the research.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- They were divided into two groups: control group and experimental group.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Questionnaires and scales were filled out by the researcher five minutes before the CT scan. Routine CT scans were performed on the control group without listening to music by wearing a Bluetooth headset. The scales were repeated five minutes after the CT scan. |
| music group | Experimental | Other: MusicQuestionnaires and scales were filled out by the researcher five minutes before the CT scan. Just before the CT scan began, the children in the music group were started to listen to "Lullaby K 350" music by inserting a Bluetooth headset into their ears. If the process took longer, the music was played again. Additionally, the Bluetooth headset was properly disinfected before each use to prevent the spread of infectious diseases among patients. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Being between the ages of 5-10
- Hospitalization is for diagnostic or treatment purposes
- The child and the parent speak and understand Turkish comfortably.
Key exclusion criteria (4 listed)
- Having previous tomography shooting experience
- Having chronic diseases
- Visual, auditory, speech and mental disorders
- There is a history of sedative, analgesic or narcotic substance use within 24 hours before application.
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 |
|---|---|---|
| MusicChildren were played music during computerized tomography. | Other | music group |
Primary outcome
Children's Fear Scale (CFS)
Time frame: one month
Children's Fear Scale is a scale scored between 0 and 4 showing five faces varying between a neutral expression (0 = no fear) to fearful face (4 = extreme fear).
1 secondary outcome
Child Anxiety Scale-State (CAS-S)
Time frame: one month
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 17 Oct 2023.
- Derived from this study: PubMed 40511812Kurudirek F, Demir Barbak Z, Demir Imamoglu Z, Ciftci K, Delice O. The Effect of Music on Fear and Anxiety of Children During Tomography: A Randomized Controlled Double-Blind Study. Int J Nurs Pract. 2025 Jun;31(3):e70029. doi: 10.1111/ijn.70029.
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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.
Fatma KURUDİREK principal investigator
Ataturk University
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 Fear and Computed Tomography, run by Gümüşhane Universıty 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 3 inclusion and 4 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 17 Oct 2023. 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?
Children's Fear Scale (CFS) (time frame: one month). 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 NCT06086509, 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 17 Oct 2023.