NCT05478369|Completed
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Sponsor study identifier
interventional
80
1 country
1
Study Start
March 19, 2022
Actual (reported)Primary Completion
July 31, 2022
Actual (reported)Study Completion
August 19, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 19, 2022
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 19, 2022
Actual (reported)July 26, 2022
Actual (reported)July 28, 2022
Actual (reported)July 31, 2022
Actual (reported)August 19, 2022
Actual (reported)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
anxiety and fear
not anxiety and fear
anxiety and fear during operative
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Ataturk University Nursing of Faculty
Erzurum, Center, 25240, Turkey (Türkiye)
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.
ARZU SARIALİOĞLU, PHD
Ataturk University
80 participants (actual enrollment reported by the registry).
First Submitted
July 26, 2022
First Posted
July 28, 2022
Study Start
March 19, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 31, 2022
Actual (reported)Study Completion
August 19, 2022
Actual (reported)Last Updated
October 27, 2022
Record last verified: 2022-10
THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
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Source: ClinicalTrials.gov.
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