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

NCT ID: NCT07009028

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2025-08-30

Brief Summary

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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

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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

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arms

No Intervention: children will receive standard care during peripheral intravenous catheterization.

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm

Experimental:storigami method will be applied during peripheral intravenous catheterization of children

Group Type EXPERIMENTAL

Storigami figure

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Storigami figure

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Ege University

OTHER

Sponsor Role lead

Responsible Party

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Ayşe Kahraman

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayşe Kahraman, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Ege Universty

Locations

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Ege University

Izmir, Bornova, Turkey (Türkiye)

Site Status RECRUITING

Ege University

Izmir, İzmir, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Emine ÇUBUKCU, MSc

Role: CONTACT

+905358700970

Ayşe Kahraman, Assoc Prof

Role: CONTACT

+905543486221

Facility Contacts

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Ayşe Kahraman, Assoc Prof

Role: primary

+905543486221

Emine ÇUBUKCU

Role: backup

+905358700970

Ayşe Kahraman, Assoc. Prof

Role: primary

+905543486221

Other Identifiers

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125S582

Identifier Type: -

Identifier Source: org_study_id

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