Clinical trial NCT07009028: The Effect of Storigami Method on Pain, Fear and Anxiety Levels Associated With Peripheral Intravenous Catheterisation in Children
Official title: The Effect of Storigami Method on Pain, Fear and Anxiety Levels Associated With Peripheral Intravenous Catheterisation in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Keywords: nurse
child
distraction methods
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2025-06-06
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Reducing the child's fear
timeFrame: during peripheral intravenous procedure
measure: Reducing the child's anxiety
timeFrame: during peripheral intravenous procedure
measure: Reducing the child's pain
timeFrame: during peripheral intravenous procedure
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
state: Bornova
city: İzmir
country: Turkey
facility: Ege University
Study officials:
affiliation: Ege Universty
name: Ayşe Kahraman, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: