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

NCT07009028 | Recruiting

• 1 other identifier: 125S582
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain

Keywords

nurse; child; distraction methods

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  during peripheral intravenous procedure

Study Arms (2)

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

Combination Product: Storigami figure

Interventions

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

Arm

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (2)

Ege University

Izmir, Bornova, 35030, Turkey (Türkiye)

RECRUITING

Ege University

Izmir, İzmir, 35030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Ayşe Kahraman, Assoc Prof

  Ege Universty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine ÇUBUKCU, MSc

CONTACT

+905358700970; eminacubukcu@gmail.com

Ayşe Kahraman, Assoc Prof

CONTACT

+905543486221; ayse.ersun@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 6, 2025
• Study Start: May 20, 2025
• Primary Completion: August 20, 2025
• Study Completion: August 30, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)