INTRAVENOUS CATHETER APPLICATIONNCT07245043
The Effect of Sticker Intervention on Pain and Anxiety
A study of INTRAVENOUS CATHETER APPLICATION and Pain, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
Peripheral venous catheterization, which involves the placement of an invasive device into the lumen of a peripheral vein, is a commonly used procedure in children receiving hospital treatment.IV insertion is a particularly painful and stressful experience for children. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- INTRAVENOUS CATHETER APPLICATION, Pain, Pain Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 24 Oct 2025
- 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
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-10 years,
- Children undergoing painful procedures
- Children undergoing IV procedures
Who cannot join
- Children who have undergone surgery,
- Children who have undergone procedures other than intravenous interventions,
- Children whose parents are not present,
- Children with any chronic illness or additional complaints that may trigger pain from the procedure,
- Children with mental retardation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mardin Education and Research Hospital
Mardin, Artuklu, 47100
About this study
Official title: The Effect of Sticker Intervention on Pain and Anxiety Experienced During IV Intervention
Peripheral venous catheterization, which involves the placement of an invasive device into the lumen of a peripheral vein, is a commonly used procedure in children receiving hospital treatment.IV insertion is a particularly painful and stressful experience for children. This is because children have more limited coping skills than adults. This study was designed as a randomized controlled trial to examine the effect of sticker intervention on pain and anxiety experienced during IV insertion.
Read the detailed description
The study consists of an sticker group and a control group. Participants will be assigned to groups using stratified randomization. Anxiety levels in both groups will be assessed using the Children's Anxiety Scale-State (ÇAS-D), while pain levels will be evaluated by both the child and the researcher using a visual pain scale before, during, and after the procedure.For children in both groups, 10 minutes before the intravenous procedure, both the child and the researcher will rate the child's anxiety and pain using scales.During the IV procedure, the researcher will place the sticker chosen by the child on the IV insertion site. Meanwhile, the researcher will rate the child's anxiety and pain using scales. No sticker will be placed on the IV insertion site of the control group, and the child's anxiety and pain will be rated using scales.For both groups, 10 minutes after the intravenous procedure, both the child and the researcher will rate the child's anxiety and pain using scales.
- Conditions
- INTRAVENOUS CATHETER APPLICATION, Pain, Pain Management, Anxiety
- Being tested
- control group
- Keywords
- intravenous catheter application, children, pain management, anxiety
- Medical subject headings
- Pain, Agnosia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupBehavioural
Children in the control group will not undergo any procedures other than routine hospital procedures. Children's anxiety and pain will be assessed based on both the researcher's and the child's reports before, during, and after the procedure, following consent from the mothers.
| Study group | Role | What they receive |
|---|---|---|
| Sticker Group | Experimental | The researcher will provide stickers that children in the sticker group can choose according to their own preferences during the application phase.Children's anxiety and pain will be assessed based on both the researcher's and the child's reports before, during, and after the procedure, following consent from the mothers. Receives: Behavioral: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Outcome Measures
The outcome measures for the sociodemographic data of the study will be collected using an "Information Form" containing questions about the child's age, gender, and descriptive characteristics such as whether they have previously had an intravenous catheter inserted.
Measured: For children in both groups: Ten minutes before the intravenous procedure, during the procedure, and ten minutes after the procedure, both the child and the researcher will rate the child's anxiety and pain using scales.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Jul 2025
- Primary completion24 Sep 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for INTRAVENOUS CATHETER APPLICATIONStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Before implementing data collection tools, children and mothers will be informed, and data will be collected through face-to-face interviews using data collection forms after obtaining consent from those who agree to participate in the study. Children in the sticker group will be provided with stickers by the researcher during the application phase, which they can choose according to their own preferences.Children's anxiety and pain will be assessed based on both the researcher's and the child's reports before, during, and after the procedure, following consent from the mothers.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HASRET YAĞMUR SEVİNÇ AKIN, Harran University
- Investigators
- HASRET YAĞMUR SEVİNÇ AKIN, Assistant Professor, Study director, Harran UniversityMAKSUDE YILDIRIM, Assistant Professor, Study chair, Adiyaman UniversityBARIŞ AKIN, Specialist Nurse, Principal investigator, MARDIN EDUCATION AND RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245043
- Sponsor's protocol ID
- HRU/25.12.67
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data from the study will be published as a scientific article.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sticker Intervention on Pain and Anxiety Experienced During IV Intervention
- ClinicalTrials.gov ID
- NCT07245043
- Acronym / sponsor ID
- HRU/25.12.67
- Conditions
- INTRAVENOUS CATHETER APPLICATION, Pain, Pain Management, Anxiety
- Keywords
- intravenous catheter application, children, pain management, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 24 Nov 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.
Peripheral venous catheterization, which involves the placement of an invasive device into the lumen of a peripheral vein, is a commonly used procedure in children receiving hospital treatment.IV insertion is a particularly painful and stressful experience for children. This is because children have more limited coping skills than adults. This study was designed as a randomized controlled trial to examine the effect of sticker intervention on pain and anxiety experienced during IV insertion.
Detailed description
The study consists of an sticker group and a control group. Participants will be assigned to groups using stratified randomization. Anxiety levels in both groups will be assessed using the Children's Anxiety Scale-State (ÇAS-D), while pain levels will be evaluated by both the child and the researcher using a visual pain scale before, during, and after the procedure.For children in both groups, 10 minutes before the intravenous procedure, both the child and the researcher will rate the child's anxiety and pain using scales.During the IV procedure, the researcher will place the sticker chosen by the child on the IV insertion site. Meanwhile, the researcher will rate the child's anxiety and pain using scales. No sticker will be placed on the IV insertion site of the control group, and the child's anxiety and pain will be rated using scales.For both groups, 10 minutes after the intravenous procedure, both the child and the researcher will rate the child's anxiety and pain using scales.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before implementing data collection tools, children and mothers will be informed, and data will be collected through face-to-face interviews using data collection forms after obtaining consent from those who agree to participate in the study. Children in the sticker group will be provided with stickers by the researcher during the application phase, which they can choose according to their own preferences.Children's anxiety and pain will be assessed based on both the researcher's and the child's reports before, during, and after the procedure, following consent from the mothers.
| Arm | Type | Receives |
|---|---|---|
| Sticker Group | Experimental | Behavioral: control groupThe researcher will provide stickers that children in the sticker group can choose according to their own preferences during the application phase.Children's anxiety and pain will be assessed based on both the researcher's and the child's reports before, during, and after the procedure, following consent from the mothers. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 5-10 years,
- Children undergoing painful procedures
- Children undergoing IV procedures
Key exclusion criteria (5 listed)
- Children who have undergone surgery,
- Children who have undergone procedures other than intravenous interventions,
- Children whose parents are not present,
- Children with any chronic illness or additional complaints that may trigger pain from the procedure,
- Children with mental retardation
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 |
|---|---|---|
| control groupChildren in the control group will not undergo any procedures other than routine hospital procedures. Children's anxiety and pain will be assessed based on both the researcher's and the child's reports before, during, and after the procedure, following consent from the mothers. | Behavioural | Sticker Group |
Primary outcome
1. Outcome Measures
Time frame: For children in both groups: Ten minutes before the intravenous procedure, during the procedure, and ten minutes after the procedure, both the child and the researcher will rate the child's anxiety and pain using scales.
The outcome measures for the sociodemographic data of the study will be collected using an "Information Form" containing questions about the child's age, gender, and descriptive characteristics such as whether they have previously had an intravenous catheter inserted.
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 24 Nov 2025.
- Individual participant dataSharing planned: No. The data from the study will be published as a scientific article.
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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.
HASRET YAĞMUR SEVİNÇ AKIN, Assistant Professor study director
Harran University
MAKSUDE YILDIRIM, Assistant Professor study chair
Adiyaman University
BARIŞ AKIN, Specialist Nurse principal investigator
MARDIN EDUCATION AND RESEARCH HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of INTRAVENOUS CATHETER APPLICATION and Pain, run by Harran 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 3 inclusion and 5 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 24 Nov 2025. 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?
1. Outcome Measures (time frame: For children in both groups: Ten minutes before the intravenous procedure, during the procedure, and ten minutes after the procedure, both the child and the researcher will rate the child's anxiety and pain using scales.). 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 24 Nov 2025.