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NCT Number: NCT07009028

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University, Izmir, Bornova, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Storigami figure

Combination Product

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

Primary outcomes

  1. 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.

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşe Kahraman, Assoc Prof

CONTACT

[email protected]

+905543486221

Emine ÇUBUKCU, MSc

CONTACT

[email protected]

+905358700970

Sponsors and collaborators

Lead sponsor

Ege University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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