PainNCT07009028
The Effect of Storigami Method on Pain, Fear and Anxiety Levels Associated With Peripheral Intravenous Catheterisation in Children
A study testing Storigami figure in people with Pain, run by Ege University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of storigami method on reducing pain, fear and anxiety of children in peripheral intravenous catheter applications in children aged 6-9 years who were hospitalized in the pediatric health and diseases clinic. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Storigami figure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 May 2025to 30 Aug 2025
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Volunteering to participate in the study
- The child is between 6-9 years old
- First time peripheral intravenous catheter insertion since admission to the clinic
- The child has no vision, hearing and speech problems
- The child has no mental retardation
- Know/speak Turkish
- No complaints such as pain, nausea and vomiting that may affect fear and anxiety
- No sedative or analgesic was given to the child immediately before the peripheral intravenous catheterization procedure
Who cannot join
- The child has a chronic, congenital, metabolic or neurodegenerative disease
- Failed attempt at peripheral intravenous catheterization,
- Failure to complete or incomplete completion of questionnaires,
- A different invasive intervention was performed immediately before PIC application,
- The child does not comply during the procedure,
- The child wants to leave the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ege University
Izmir, Bornova, 35030
Ayşe Kahraman, Assoc Prof, +905543486221, ayse.ersun@gmail.com
Emine ÇUBUKCU, +905358700970, eminacubukcu@gmail.com
- Recruiting
Ege University
Izmir, İzmir, 35030
Ayşe Kahraman, Assoc. Prof, +905543486221, ayse.ersun@gmail.com
Ayşe Kahraman, Assoc Prof
About this study
The aim of this study was to determine the effect of storigami method on reducing pain, fear and anxiety of children in peripheral intravenous catheter applications in children aged 6-9 years who were hospitalized in the pediatric health and diseases clinic.
Read the detailed description
He stated that children and their families who frequently visit hospitals for follow-up, treatment or various anomalies have negative hospital experiences due to fear, anxiety and painful procedures, and that these negative experiences may cause phobias and avoidance of medical procedures in children in the future. Therefore, this study was planned to determine the effect of storigami method on reducing pain, fear and anxiety of children in peripheral intravenous catheter applications in children aged 6-9 years who were hospitalized in the pediatric health and diseases clinic. Storigami is a method that involves the use of origami and stories at the same time and can be used to reduce pain in hospitals. The method, which is planned to be used to minimize negative hospital experiences, is thought to be a promising, cost-effective and safe non-pharmacological technique that can be used safely to reduce fear, anxiety and pain of hospitalized patients.
- Conditions
- Pain
- Being tested
- Storigami figure
- Keywords
- nurse, child, distraction methods
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storigami figureCombination product
Combination Produc: The origami figure that will be formed as a result of the process will be used as a distraction method
| Study group | Role | What they receive |
|---|---|---|
| Arms | No intervention | No Intervention: children will receive standard care during peripheral intravenous catheterization. |
| Arm | Experimental | Experimental:storigami method will be applied during peripheral intravenous catheterization of children Receives: Combination Product: Storigami figure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing the child's fear
The Children's Fear Scale (CFS) was graded on a scale of 0-4 and included five display images with facial expressions ranging from neutral (0 = no anxiety) to fearful (4 = severe anxiety). Children between the ages of 5 and 10 can use it before and after treatments.
For child and proxy reports, it contain different instructions to reduce the child's fear during the peripheral intravenous catheterization procedure.
Measured: during peripheral intravenous procedure
Reducing the child's anxiety
Child Anxiety Scale-State (CASsingle bondS). Its bottom resembles a lightbulb, and its horizontal lines with upward ranges like those of a thermometer. To measure state anxiety, the child is asked to say that he feels "now" It applied to kids ages 4 to 12 and had a range of 0 to 10. There is a direction in the scale "NOW color where you FEEL on the thermometer, too much tension or anxious, calm: not tension or anxious? Children were asked to "Pretend that all your worried or nervous feelings are in the very bottom down here (point to scale). If you are a little bit worried or nervous, the feelings might come up just a little bit (move your finger up). If you are very, very worried or nervous, the feelings might go all the way to the top (move your finger up to the top). Put a line showing how much worry or nervousness you feel." It ranges from 0 to 10 and can be applied to children aged 4-12.
Reduce the child's anxiety during the peripheral intravenous catheterization procedure
Measured: during peripheral intravenous procedure
Reducing the child's pain
This scale, which has six faceted expressions and assigns a pain score based on the numerical values of the faces, is used to diagnose pain in children. It is used to assess the pain in children three years and older. Faces can display a range of emotions, from crying (10 = most painful) to smiling (0 = no pain)
reduce the child's pain during the peripheral intravenous catheterization procedure
Measured: during peripheral intravenous procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start20 May 2025
- Primary completion20 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ege 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
- Model description
- The population of the randomized controlled experimental study consisted of children aged 6-9 years who were admitted to the Pediatrics Clinic and hospitalized in the hospital.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Ayşe Kahraman, Ege University
- Investigators
- Ayşe Kahraman, Assoc Prof, Principal investigator, Ege Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009028
- Sponsor's protocol ID
- 125S582
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 6 Jun 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Storigami Method on Pain, Fear and Anxiety Levels Associated With Peripheral Intravenous Catheterisation in Children
- ClinicalTrials.gov ID
- NCT07009028
- Acronym / sponsor ID
- 125S582
- Conditions
- Pain
- Keywords
- nurse, child, distraction methods
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 6 Jun 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 aim of this study was to determine the effect of storigami method on reducing pain, fear and anxiety of children in peripheral intravenous catheter applications in children aged 6-9 years who were hospitalized in the pediatric health and diseases clinic.
Detailed description
He stated that children and their families who frequently visit hospitals for follow-up, treatment or various anomalies have negative hospital experiences due to fear, anxiety and painful procedures, and that these negative experiences may cause phobias and avoidance of medical procedures in children in the future. Therefore, this study was planned to determine the effect of storigami method on reducing pain, fear and anxiety of children in peripheral intravenous catheter applications in children aged 6-9 years who were hospitalized in the pediatric health and diseases clinic. Storigami is a method that involves the use of origami and stories at the same time and can be used to reduce pain in hospitals. The method, which is planned to be used to minimize negative hospital experiences, is thought to be a promising, cost-effective and safe non-pharmacological technique that can be used safely to reduce fear, anxiety and pain of hospitalized patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The population of the randomized controlled experimental study consisted of children aged 6-9 years who were admitted to the Pediatrics Clinic and hospitalized in the hospital.
| Arm | Type | Receives |
|---|---|---|
| Arms | No intervention | –No Intervention: children will receive standard care during peripheral intravenous catheterization. |
| Arm | Experimental | Combination Product: Storigami figureExperimental:storigami method will be applied during peripheral intravenous catheterization of children |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Volunteering to participate in the study
- The child is between 6-9 years old
- First time peripheral intravenous catheter insertion since admission to the clinic
- The child has no vision, hearing and speech problems
- The child has no mental retardation
Key exclusion criteria (6 listed)
- The child has a chronic, congenital, metabolic or neurodegenerative disease
- Failed attempt at peripheral intravenous catheterization,
- Failure to complete or incomplete completion of questionnaires,
- A different invasive intervention was performed immediately before PIC application,
- The child does not comply during the procedure,
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 |
|---|---|---|
| Storigami figureCombination Produc: The origami figure that will be formed as a result of the process will be used as a distraction method | Combination product | Arm |
Primary outcome
Reducing the child's fear
Time frame: during peripheral intravenous procedure
The Children's Fear Scale (CFS) was graded on a scale of 0-4 and included five display images with facial expressions ranging from neutral (0 = no anxiety) to fearful (4 = severe anxiety). Children between the ages of 5 and 10 can use it before and after treatments. For child and proxy reports, it contain different instructions to reduce the child's fear during the peripheral intravenous catheterization procedure.
Reducing the child's anxiety
Time frame: during peripheral intravenous procedure
Child Anxiety Scale-State (CASsingle bondS). Its bottom resembles a lightbulb, and its horizontal lines with upward ranges like those of a thermometer. To measure state anxiety, the child is asked to say that he feels "now" It applied to kids ages 4 to 12 and had a range of 0 to 10. There is a direction in the scale "NOW color where you FEEL on the thermometer, too much tension or anxious, calm: not tension or anxious? Children were asked to "Pretend that all your worried or nervous feelings are in the very bottom down here (point to scale). If you are a little bit worried or nervous, the feelings might come up just a little bit (move your finger up). If you are very, very worried or nervous, the feelings might go all the way to the top (move your finger up to the top). Put a line showing how much worry or nervousness you feel." It ranges from 0 to 10 and can be applied to children aged 4-12. Reduce the child's anxiety during the peripheral intravenous catheterization procedure
Reducing the child's pain
Time frame: during peripheral intravenous procedure
This scale, which has six faceted expressions and assigns a pain score based on the numerical values of the faces, is used to diagnose pain in children. It is used to assess the pain in children three years and older. Faces can display a range of emotions, from crying (10 = most painful) to smiling (0 = no pain) reduce the child's pain during the peripheral intravenous catheterization procedure
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 6 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Ayşe Kahraman, Assoc Prof principal investigator
Ege Universty
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Storigami figure in people with Pain, run by Ege University at 2 sites 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Emine ÇUBUKCU, MSc (+905358700970, eminacubukcu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing the child's fear (time frame: during peripheral intravenous procedure). The study lists 3 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 6 Jun 2025.