NCT05478369

Brief Summary

The aim of this project is to determine the effect of reading the story book, which is considered within the scope of the pedagogically approved research that introduces the surgical environment before the surgical intervention in children, on the pain and anxiety of the child. The project is a randomized controlled trial. The population of the research will be children between the ages of 4 and 6 who come to Atatürk University Health Research and Application Center Pediatric Surgery Clinic between March and September 2022 for treatment. The research sample; children and parents who are hospitalized in the clinic on the dates specified by the probabilistic sampling method and meet the research criteria, willing to participate in the research. "Survey Form", "Modified Yale Preoperative Anxiety Scale (mYPAS)" and "Child Fear Scale" will be used in data collection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2022

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

July 26, 2022

Last Update Submit

October 25, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Child Fear Scale (CFS)

    The scale was developed in 2011. The Child Fear Scale is used to determine the level of fear in children undergoing painful medical procedures. The Child Fear Scale is a scale from 0-4 showing five faces ranging from a neutral expression (0 = no worry) to the feared face (4 = serious anxiety).

    9 MONTHS

  • Modified Yale Preoperative Anxiety Scale (mYPAS)

    Yale Preoperative Anxiety Scale (YPAS), which was developed in 1995 to measure children's preoperative anxiety, was modified in 1997 (mYPAS) and used in many studies covering various health fields such as dentistry, anesthesia, surgery, and pediatrics. The scale evaluates five basic parameters. These; Activity includes speech, emotional state, marked arousal, and relationship with family. In the scale, the parameters of activity, emotional state, marked arousal state, and family relationship are evaluated between (1-4) and speech (1-6).

    9 MONTHS

Study Arms (2)

storybook

EXPERIMENTAL

anxiety and fear

Behavioral: storybook

control

NO INTERVENTION

not anxiety and fear

Interventions

storybookBEHAVIORAL

anxiety and fear during operative

storybook

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Between the ages of 4-6
  • Hernias, undescended testis surgery
  • Does not have a disability related to developmental areas
  • parent's literacy

You may not qualify if:

  • Not between 4-6 years old
  • No hernias, undescended testis surgery
  • Having a disability related to developmental areas
  • parent's illiteracy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Nursing of Faculty

Erzurum, Center, 25240, Turkey (Türkiye)

Location

Related Publications (1)

  • Sarialioglu A, Kurudirek F, Oluc T. The effect of storybook reading on children's preoperative fear and anxiety levels: A randomized controlled study. Child Care Health Dev. 2023 Sep;49(5):906-913. doi: 10.1111/cch.13100. Epub 2023 Feb 8.

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • ARZU SARIALİOĞLU, PHD

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 26, 2022

First Posted

July 28, 2022

Study Start

March 19, 2022

Primary Completion

July 31, 2022

Study Completion

August 19, 2022

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED

Locations