Pediatric DisorderNCT05303454
Cartoons and Musical-moving Toys in Invasive Procedure Applications Reduce Pain and Fear Levels of Children
A study testing Cartoons and musical-moving toys in people with Pediatric Disorder, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study is to determine the effect of the cartoon and musical-moving toy watched in the invasive procedure application on the pain and fear level of children. Material and Method: The research was carried out as a randomized controlled experiment in Atatürk University Health Research and Application… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Pediatric Disorder
- What is being tested?
- Cartoons and musical-moving toys
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Mar 2021to 19 Feb 2022
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- between 3-6 years old,
- Does not have a chronic disease,
- Does not have a disability related to developmental areas,
- Not receiving inpatient treatment in the hospital,
- No history of sedative, analgesic or narcotic substance use within 24 hours before admission,
- Not having a febrile illness at the time of application,
- Children whose parents were with the child during the procedure were included in the study.
Who cannot join
- NOT aged between 3-6 years,
- Having a chronic illness
- Having a disability related to developmental areas,
- Receiving inpatient treatment in the hospital,
- Having a history of sedative, analgesic or narcotic substance use within 24 hours before admission,
- Having a febrile illness at the time of application,
- Children whose parents were not present during the procedure were included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Nursing of Faculty
Erzurum, Center, 25240
About this study
Official title: Cartoons and Musical-moving Toys in Invasive Procedure Applications Reduce Pain and Fear Levels of Children: A Randomized Controlled Study
Aim: The aim of this study is to determine the effect of the cartoon and musical-moving toy watched in the invasive procedure application on the pain and fear level of children.
Material and Method: The research was carried out as a randomized controlled experiment in Atatürk University Health Research and Application Center Pediatric Emergency Service between March 2021 and February 2022. The population of the study consisted of children between the ages of 3 and 6 who came for treatment at the specified hospital. The sample of the research; 40 cartoons, 40 musical-moving toys, 40 control group, totally 120 children who applied to the pediatric emergency service between June 2021 and January 2022 and met the research criteria and volunteered to participate in the research. Data collection tools were collected through face-to-face interviews with "Survey Form", "Wong-Baker Faces Pain Rating Scale (WBS)" and "Child Fear Scale (CFS)". In the research, "cartoon" and "musical-moving toy" were used as intervention tools.
Read the detailed description
Aim: The aim of this study is to determine the effect of the cartoon and musical-moving toy watched in the invasive procedure application on the pain and fear level of children.
Material and Method: The research was carried out as a randomized controlled experiment in Atatürk University Health Research and Application Center Pediatric Emergency Service between March 2021 and February 2022. There is one intervention room in the Pediatric Emergency Service. There are blood collection stretcher, vascular access-bleeding materials (intraket, cotton, 70% alcohol, tourniquet, plaster, injector, blood tubes, etc.) in this room.The population of the study consisted of children between the ages of 3 and 6 who came for treatment at the specified hospital. In order to ensure randomization, the children who met the criteria were included in the control group in the first week, the children in the second week were included in the cartoon group, and the children in the third week were included in the musical-moving toy group, and this cycle was continued until the end of the study and randomization was achieved.The sample of the research; 40 cartoons, 40 musical-moving toys, 40 control group, totally 120 children who applied to the pediatric emergency service between June 2021 and January 2022 and met the research criteria and volunteered to participate in the research. Children from 2 experimental and 2 control groups who did not want to participate in the study were excluded from the study. Prior power analysis was performed to determine the adequacy of the sample size of the study. In the power analysis, it was determined that the study was at the significance level of 0.05, at the 95% confidence interval, and the effect size was 0.551 and the power was 0.99. Data collection tools were collected through face-to-face interviews with "Survey Form", "Wong-Baker Faces Pain Rating Scale (WBS)" and "Child Fear Scale (CFS)". In the research, "cartoon" and "musical-moving toy" were used as intervention tools. Two different cartoons were used in the research, and these were the children's favorites, 'Red Fish' and 'Niloya'. Pepee is a toy suitable for the developmental characteristics of children aged three and over. The data were analyzed with the SPSS for Windows 22 package program. Ethical principles were followed in the research. The research sample is limited to pediatric patients who applied to Atatürk University Health Research and Application Center Pediatric Emergency Service between June and December 2021 and participated in the study voluntarily. Research results can be generalized to this group.
- Conditions
- Pediatric Disorder
- Being tested
- Cartoons, musical-moving toys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CartoonsBehavioural
cartoons were found to be effective in reducing children's pain and fear levels.
musical-moving toysBehavioural
musical-moving toys were found to be effective in reducing children's pain and fear levels.
| Study group | Role | What they receive |
|---|---|---|
| Cartoons | Experimental | Reduce Pain and Fear Levels of Children Receives: Behavioral: Cartoons |
| Musical-moving Toys | Experimental | Reduce Pain and Fear Levels of Children Receives: Behavioral: musical-moving toys |
| CONTROL | No intervention | NOT Reduce Pain and Fear Levels of Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Facial Expression Rating Scale
This scale is used to diagnose pain in children aged 3-18 years. In this scale, there are six facial expressions representing the increasing pain intensity from 0 to 5 from left to right. The leftmost facial expression has a smiling expression indicating a pain-free state, while the rightmost facial expression has a crying expression corresponding to the most severe pain. The child is instructed to choose the face that best expresses his or her feelings. Six facial expressions are scored between 0-5 points from left to right (0 points = very happy/no pain, 5 points = indicates the most severe pain). As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.
Measured: 8 MONTHS
Child Fear Scale
The CLS is a scale of 0-4, showing five faces ranging from a neutral expression (0 = no concern) to the feared face (4 = severe anxiety). The child is told to choose the best facial expression that expresses his or her feelings. As the score obtained from the scale increases, the child's fear level increases.
Measured: 8 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start19 Mar 2021
- Primary completion27 Dec 2021
- Study completion19 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DisorderStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZU SARIALİOĞLU, Ataturk University
- Investigators
- ARZU SARIALİOĞLU, PHD, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303454
- Sponsor's protocol ID
- B.30.2.ATA.O.oı.OO/36
- Status last verified
- Mar 2022
- First submitted
- 19 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cartoons and Musical-moving Toys in Invasive Procedure Applications Reduce Pain and Fear Levels of Children: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05303454
- Acronym / sponsor ID
- B.30.2.ATA.O.oı.OO/36
- Conditions
- Pediatric Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 19 Feb 2022 (actual)
- First posted
- 31 Mar 2022 (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.
Aim: The aim of this study is to determine the effect of the cartoon and musical-moving toy watched in the invasive procedure application on the pain and fear level of children.
Material and Method: The research was carried out as a randomized controlled experiment in Atatürk University Health Research and Application Center Pediatric Emergency Service between March 2021 and February 2022. The population of the study consisted of children between the ages of 3 and 6 who came for treatment at the specified hospital. The sample of the research; 40 cartoons, 40 musical-moving toys, 40 control group, totally 120 children who applied to the pediatric emergency service between June 2021 and January 2022 and met the research criteria and volunteered to participate in the research. Data collection tools were collected through face-to-face interviews with "Survey Form", "Wong-Baker Faces Pain Rating Scale (WBS)" and "Child Fear Scale (CFS)". In the research, "cartoon" and "musical-moving toy" were used as intervention tools.
Detailed description
Aim: The aim of this study is to determine the effect of the cartoon and musical-moving toy watched in the invasive procedure application on the pain and fear level of children.
Material and Method: The research was carried out as a randomized controlled experiment in Atatürk University Health Research and Application Center Pediatric Emergency Service between March 2021 and February 2022. There is one intervention room in the Pediatric Emergency Service. There are blood collection stretcher, vascular access-bleeding materials (intraket, cotton, 70% alcohol, tourniquet, plaster, injector, blood tubes, etc.) in this room.The population of the study consisted of children between the ages of 3 and 6 who came for treatment at the specified hospital. In order to ensure randomization, the children who met the criteria were included in the control group in the first week, the children in the second week were included in the cartoon group, and the children in the third week were included in the musical-moving toy group, and this cycle was continued until the end of the study and randomization was achieved.The sample of the research; 40 cartoons, 40 musical-moving toys, 40 control group, totally 120 children who applied to the pediatric emergency service between June 2021 and January 2022 and met the research criteria and volunteered to participate in the research. Children from 2 experimental and 2 control groups who did not want to participate in the study were excluded from the study. Prior power analysis was performed to determine the adequacy of the sample size of the study. In the power analysis, it was determined that the study was at the significance level of 0.05, at the 95% confidence interval, and the effect size was 0.551 and the power was 0.99. Data collection tools were collected through face-to-face interviews with "Survey Form", "Wong-Baker Faces Pain Rating Scale (WBS)" and "Child Fear Scale (CFS)". In the research, "cartoon" and "musical-moving toy" were used as intervention tools. Two different cartoons were used in the research, and these were the children's favorites, 'Red Fish' and 'Niloya'. Pepee is a toy suitable for the developmental characteristics of children aged three and over. The data were analyzed with the SPSS for Windows 22 package program. Ethical principles were followed in the research. The research sample is limited to pediatric patients who applied to Atatürk University Health Research and Application Center Pediatric Emergency Service between June and December 2021 and participated in the study voluntarily. Research results can be generalized to this group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cartoons | Experimental | Behavioral: CartoonsReduce Pain and Fear Levels of Children |
| Musical-moving Toys | Experimental | Behavioral: musical-moving toysReduce Pain and Fear Levels of Children |
| CONTROL | No intervention | –NOT Reduce Pain and Fear Levels of Children |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- between 3-6 years old,
- Does not have a chronic disease,
- Does not have a disability related to developmental areas,
- Not receiving inpatient treatment in the hospital,
- No history of sedative, analgesic or narcotic substance use within 24 hours before admission,
Key exclusion criteria (7 listed)
- NOT aged between 3-6 years,
- Having a chronic illness
- Having a disability related to developmental areas,
- Receiving inpatient treatment in the hospital,
- Having a history of sedative, analgesic or narcotic substance use within 24 hours before admission,
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 |
|---|---|---|
| Cartoonscartoons were found to be effective in reducing children's pain and fear levels. | Behavioural | Cartoons |
| musical-moving toysmusical-moving toys were found to be effective in reducing children's pain and fear levels. | Behavioural | Musical-moving Toys |
Primary outcome
Wong-Baker Facial Expression Rating Scale
Time frame: 8 MONTHS
This scale is used to diagnose pain in children aged 3-18 years. In this scale, there are six facial expressions representing the increasing pain intensity from 0 to 5 from left to right. The leftmost facial expression has a smiling expression indicating a pain-free state, while the rightmost facial expression has a crying expression corresponding to the most severe pain. The child is instructed to choose the face that best expresses his or her feelings. Six facial expressions are scored between 0-5 points from left to right (0 points = very happy/no pain, 5 points = indicates the most severe pain). As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.
Child Fear Scale
Time frame: 8 MONTHS
The CLS is a scale of 0-4, showing five faces ranging from a neutral expression (0 = no concern) to the feared face (4 = severe anxiety). The child is told to choose the best facial expression that expresses his or her feelings. As the score obtained from the scale increases, the child's fear level increases.
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 31 Mar 2022.
- Individual participant dataSharing planned: No. THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
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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.
ARZU SARIALİOĞLU, PHD study director
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 Cartoons and musical-moving toys in people with Pediatric Disorder, run by Ataturk 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 7 inclusion and 7 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 31 Mar 2022. 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?
Wong-Baker Facial Expression Rating Scale (time frame: 8 MONTHS). The study lists 2 primary outcomes in all. 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 31 Mar 2022.