Sponsor study identifier
interventional
120
1 country
1
Study Start
June 19, 2022
Actual (reported)Primary Completion
October 27, 2022
Actual (reported)Study Completion
December 28, 2022
Actual (reported)The aim of this study is to determine the effect of therapeutic play applied with a hand puppet during blood collection on pain and fear in children. The project is a randomized controlled trial. The study includes children aged 3-6 years who came to the pediatric blood collection unit of Binali Yıldırım University Mengücek Gazi Training and Research Hospital between 01/07/2022 and 01/01/2023. The research sample; children who apply to the unit on the specified dates and meet the research criteria and volunteer to participate in the research. "Survey Form", "Wong-Baker Evaluation of Facial Expressions Scale" 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.
December 28, 2022
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 19, 2022
Actual (reported)June 22, 2022
Actual (reported)June 29, 2022
Actual (reported)October 27, 2022
Actual (reported)December 28, 2022
Actual (reported)Wong-Baker Facial Expression Evaluation Scale (WB-FAI)
The scale was developed in 1981 and was revised in 1983. The scale is used to define pain in the 3-18 age group. The scale indicates that the severity of pain increases from zero to five as you go from left to right. Facial expressions are included under the numbers to describe the severity of pain. It consists of 6 faces in total. While the first smiling facial expression expresses the pain-free state, the crying facial expression at the end indicates the most severe pain intensity. While applying the scale, the child is told to choose the facial expression that best describes his feelings at the moment. Six facial expressions are scored between 0-5 points from left to right (0 points = very happy/no pain, 5 points = indicates the most severe pain). As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.
9 MONTHS
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
pain and fear
not pain and fear
pain and fear during blood collection
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)
ARZU SARIALİOĞLU, PHD
Ataturk University
120 participants (actual enrollment reported by the registry).
First Submitted
June 22, 2022
First Posted
June 29, 2022
Study Start
June 19, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 27, 2022
Actual (reported)Study Completion
December 28, 2022
Actual (reported)Last Updated
April 4, 2023
Record last verified: 2023-04
THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
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Source: ClinicalTrials.gov.
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