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Recruiting NCT07009028

The Effect of Storigami Method on Pain, Fear and Anxiety Levels Associated With Peripheral Intravenous Catheterisation in Children

No phase Interventional Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Storigami figure.
Who it may be relevant to
Registry conditions: Pain. Basic parameters: 6 years — 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Combination product Storigami figure
    Combination Produc: The origami figure that will be formed as a result of the process will be used as a distraction method

Primary outcome measures

  • Reducing the child's fear [Time frame: during peripheral intravenous procedure]
  • Reducing the child's anxiety [Time frame: during peripheral intravenous procedure]
  • Reducing the child's pain [Time frame: during peripheral intravenous procedure]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 2 centers
  • Ege University — Izmir
  • Ege University — Izmir

Identifiers

NCT: NCT07009028 · 125S582

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗