An interventional study of Experimental group in Procedural Pain, Acute Pain and Fear, sponsored by Burdur Mehmet Akif Ersoy University. Completed at 1 site in Turkey. Open to participants aged 4 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Burdur Mehmet Akif Ersoy University · Not applicable, Interventional, and Supportive care
The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using vacutainers of three different animal characters.
In the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain. In light of this information, this study aimed to compare the effects of vacutainers of three different animal characters on fear, anxiety, and pain in children during bloodletting.
The study is a prospective, randomized and controlled trial.Children aged 4 to 7 years who required blood draw were divided into three groups; two groups: experimental and control groups. Animal characters (butterfly, peacock and rabbit) chosen by children in the experimental group was attached to the vacutainer, and then their blood was drawn. The data were obtained by face-to-face interviews with the child, parent and observer before and after the procedure. Children's pain and fear/anxiety levels were evaluated using the Children's Fear Scale and theWong-Baker FACES Pain Scale, respectively.
The study population consisted of children aged 4 to 7 years who presented to the children's blood draw room of the hospital.
Sample of the study consisted of a total of 1800 children who met the sample selection criteria and were selected via randomization method.
Data were collected using the Interview and Observation Form, Children's Fear Scale, and Wong-Baker FACES Pain Rating Scale.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 180 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Burdur Mehmet Akif Ersoy University is the lead sponsor of 48 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
The animal characters were shown to the child before the bloodletting procedure. The child was asked to choose one of them and the one chosen by the child was attached to the vacutainer.
Behavioral: Experimental group
The child was subjected to routine bloodletting intervention with the vacutainer.
The animal characters were shown to the child before the bloodletting procedure. The child was asked to choose one of them and the one chosen by the child was attached to the vacutainer. The child and their parents were taken to the blood collection room. During the bloodletting procedure, the child was asked to focus on the animal character they had chosen.
Children's Fear Scale
CFS is used for measuring the child's anxiety level. CFS is a scale which makes an evaluation from 0 to 4 consisting of five facial expressions drawn to show expressions that vary from neutral expression (0=no anxiety) to scared face (4=severe anxiety).
Time frame: Through painful procedure completion, an average of 10 minutes
Wong-Baker FACES Pain Rating Scale
In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels.
Time frame: Through painful procedure completion, an average of 10 minutes.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Burdur Mehmet Akif Ersoy University