6-12 Years OldNCT07127081
Intravenous Catheter Application
A study testing Stress ball and Cartoons in people with 6-12 Years Old, run by Toros University.
Trial summary
The study was a randomised controlled trial showing the effect of watching cartoons and squeezing a stress ball on pain and fear in children admitted for intravenous catheter insertion. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- 6-12 Years Old
- What is being tested?
- Stress ball and Cartoons
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Those who were admitted to Toros State Hospital, Child service on 01 September 2025- 01.02.2026,
- Children aged 6 to 12 years,
- Children scheduled for intravenous catheterisation,
- Children without mental and developmental retardation,
- Children who can speak and understand Turkish,
- Children and parents who signed an informed consent form.
Who cannot join
- Children who cannot speak or communicate in Turkish,
- Children whose first attempt to insert an intravenous catheter failed,
- Children and parents who did not sign the informed consent form.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Stress Ball and Watching Cartoons on Pain and Fear During Intravenous Catheter Application in Children: A Randomised Controlled Study
The study was a randomised controlled trial showing the effect of watching cartoons and squeezing a stress ball on pain and fear in children admitted for intravenous catheter insertion. Hypotheses of the Study Hypothesis 1: Children who watch cartoons during intravenous catheter insertion have lower pain and fear scores than the control group.
Hypothesis 2: The pain and fear of children who squeeze a stress ball during intravenous catheter insertion are lower than the control group Hypothesis 3: There is a difference between the pain and fear scores of children who watch cartoons and squeeze a stress ball.
Read the detailed description
Explain how you determined the number The population of the study will consist of children admitted to the paediatric clinic of a State Hospital between 01 September 2025 and 01 February 2026. While calculating the sample size, the intergroup G*Power 3.1.9.4 maximum 10% type II error rate (1 - β = 0.90), maximum 5% type I error rate (α = 0.05), two-way hypothesis minimum sample size was determined as 90. It was planned to have 30 children in each group, with a total sample size of 90.
Implementation of Research:
Groups will be formed by computer-aided randomisation. Explanations will be made in accordance with the developmental level before the procedure. In the study, children will be divided into 3 groups as two intervention and one control group. The intervention groups are "Watching Cartoon Film" and "Squeezing Stress Ball". Cartoon Group: Two minutes before the intravenous catheter is inserted, the cartoon film chosen by the child will be started to be watched on the tablet. As a cartoon film, Puzzle Tower or Z Team on TRT Kids channel will be shown to children. Children will be able to watch the cartoon they want. The cartoons will be watched on a 10.2 inch iPad tablet provided by the researcher. Stress Ball Squeezing: Two minutes before the intravenous catheter is inserted, the stress ball will be squeezed. No intervention will be applied to the control group. Pain and fear scores of the child, parent and researcher will be recorded before, during and after the procedure. While the health professional performing the routine intravenous catheter procedure will intervene, the researcher will record the data before, during and after the procedure. The investigators will never perform the intravenous catheter insertion procedure. The researcher will collect relevant data from the child, parent and researcher during intravenous catheter insertion. The data will be recorded by Dr.Hem.Zühal Artuvan, one of the researchers. Consort Flow Diagram of the study is shown in Figure 1.
- Conditions
- 6-12 Years Old
- Being tested
- Stress ball, Cartoons
- Keywords
- Children, intravenous catheter, stress ball, cartoons, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ballBehavioural
The study was a randomised controlled trial showing the effect of watching cartoons and squeezing a stress ball on pain and fear in children admitted for intravenous catheter insertion.
CartoonsBehavioural
The study was a randomised controlled trial showing the effect of watching cartoons and squeezing a stress ball on pain and fear in children admitted for intravenous catheter insertion.
| Study group | Role | What they receive |
|---|---|---|
| Stress ball | Experimental | Stress ball will be applied Receives: Behavioral: Stress ball |
| Cartoons | Experimental | Cartoons will be applied Receives: Behavioral: Cartoons |
| Control | No intervention | No intervention will be made to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Pain Scale
It is the most frequently used pain assessment method. Facial expressions are considered as reliable and unbiased markers. It was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983. It is suitable to be applied at the age of three years and above. The pain level of the faces on the scale is explained to the child: "0= no pain.......10= unbearably severe pain". According to the scoring; 0-4 indicates mild pain, 5-6 indicates moderate pain, 7-8 indicates severe pain, 9-10 indicates unbearably severe pain. The administration time of the measurement tool is approximately 2 minutes [9,10,11].
Measured: 22 weeks
Children's Fear Scale
It evaluates pain-related fear in children. The Child Fear Scale (CFS), developed by McMurty et al. (2011) and validated in Turkish by Özalp-Gerçeker et al. (2018), consists of five drawn facial expressions ranging from neutral expression (0=no anxiety) to frightened face (4=severe anxiety). In the validity-reliability study, the CQI value for the scale was found to be 0.89. The test-retest reliability (0.99) was found to be quite high. The scale cut-off point is 2 and scores of 2 and above are characterised as high level of fear. The Child Fear Scale is a valid and reliable measurement tool. The administration time of the measurement tool is approximately 2 minutes [12,13].
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 6-12 Years OldStudies 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
- Model description
- There will be tree groups (2 intervention, 1 control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toros University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Behire SANÇAR, Toros University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127081
- Sponsor's protocol ID
- Toros University
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball and Watching Cartoons on Pain and Fear During Intravenous Catheter Application in Children: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT07127081
- Acronym / sponsor ID
- Toros University
- Conditions
- 6-12 Years Old
- Keywords
- Children, intravenous catheter, stress ball, cartoons, nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Toros UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 17 Aug 2025 (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 study was a randomised controlled trial showing the effect of watching cartoons and squeezing a stress ball on pain and fear in children admitted for intravenous catheter insertion. Hypotheses of the Study Hypothesis 1: Children who watch cartoons during intravenous catheter insertion have lower pain and fear scores than the control group.
Hypothesis 2: The pain and fear of children who squeeze a stress ball during intravenous catheter insertion are lower than the control group Hypothesis 3: There is a difference between the pain and fear scores of children who watch cartoons and squeeze a stress ball.
Detailed description
Explain how you determined the number The population of the study will consist of children admitted to the paediatric clinic of a State Hospital between 01 September 2025 and 01 February 2026. While calculating the sample size, the intergroup G*Power 3.1.9.4 maximum 10% type II error rate (1 - β = 0.90), maximum 5% type I error rate (α = 0.05), two-way hypothesis minimum sample size was determined as 90. It was planned to have 30 children in each group, with a total sample size of 90.
Implementation of Research:
Groups will be formed by computer-aided randomisation. Explanations will be made in accordance with the developmental level before the procedure. In the study, children will be divided into 3 groups as two intervention and one control group. The intervention groups are "Watching Cartoon Film" and "Squeezing Stress Ball". Cartoon Group: Two minutes before the intravenous catheter is inserted, the cartoon film chosen by the child will be started to be watched on the tablet. As a cartoon film, Puzzle Tower or Z Team on TRT Kids channel will be shown to children. Children will be able to watch the cartoon they want. The cartoons will be watched on a 10.2 inch iPad tablet provided by the researcher. Stress Ball Squeezing: Two minutes before the intravenous catheter is inserted, the stress ball will be squeezed. No intervention will be applied to the control group. Pain and fear scores of the child, parent and researcher will be recorded before, during and after the procedure. While the health professional performing the routine intravenous catheter procedure will intervene, the researcher will record the data before, during and after the procedure. The investigators will never perform the intravenous catheter insertion procedure. The researcher will collect relevant data from the child, parent and researcher during intravenous catheter insertion. The data will be recorded by Dr.Hem.Zühal Artuvan, one of the researchers. Consort Flow Diagram of the study is shown in Figure 1.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- There will be tree groups (2 intervention, 1 control
| Arm | Type | Receives |
|---|---|---|
| Stress ball | Experimental | Behavioral: Stress ballStress ball will be applied |
| Cartoons | Experimental | Behavioral: CartoonsCartoons will be applied |
| Control | No intervention | –No intervention will be made to this group. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Those who were admitted to Toros State Hospital, Child service on 01 September 2025- 01.02.2026,
- Children aged 6 to 12 years,
- Children scheduled for intravenous catheterisation,
- Children without mental and developmental retardation,
- Children who can speak and understand Turkish,
Key exclusion criteria (3 listed)
- Children who cannot speak or communicate in Turkish,
- Children whose first attempt to insert an intravenous catheter failed,
- Children and parents who did not sign the informed consent form.
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 |
|---|---|---|
| Stress ballThe study was a randomised controlled trial showing the effect of watching cartoons and squeezing a stress ball on pain and fear in children admitted for intravenous catheter insertion. | Behavioural | Stress ball |
| CartoonsThe study was a randomised controlled trial showing the effect of watching cartoons and squeezing a stress ball on pain and fear in children admitted for intravenous catheter insertion. | Behavioural | Cartoons |
Primary outcome
Wong-Baker Pain Scale
Time frame: 22 weeks
It is the most frequently used pain assessment method. Facial expressions are considered as reliable and unbiased markers. It was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983. It is suitable to be applied at the age of three years and above. The pain level of the faces on the scale is explained to the child: "0= no pain.......10= unbearably severe pain". According to the scoring; 0-4 indicates mild pain, 5-6 indicates moderate pain, 7-8 indicates severe pain, 9-10 indicates unbearably severe pain. The administration time of the measurement tool is approximately 2 minutes [9,10,11].
Children's Fear Scale
Time frame: 22 weeks
It evaluates pain-related fear in children. The Child Fear Scale (CFS), developed by McMurty et al. (2011) and validated in Turkish by Özalp-Gerçeker et al. (2018), consists of five drawn facial expressions ranging from neutral expression (0=no anxiety) to frightened face (4=severe anxiety). In the validity-reliability study, the CQI value for the scale was found to be 0.89. The test-retest reliability (0.99) was found to be quite high. The scale cut-off point is 2 and scores of 2 and above are characterised as high level of fear. The Child Fear Scale is a valid and reliable measurement tool. The administration time of the measurement tool is approximately 2 minutes [12,13].
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Stress ball and Cartoons in people with 6-12 Years Old, run by Toros University.
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 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: opening soon, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Behire Sançar, Dr. PhD (05052520273, behiresancar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker Pain Scale (time frame: 22 weeks). 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 27 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.