An interventional study of bee-buzzy vibrating cold application marionette doll and Rotuine care in Fear of Pain, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-06.
Sponsored by Assiut University · Not applicable, Interventional, and Supportive care
Non-pharmacological methods are often used as a creative strategy to reduce pain and fear in children during a painful procedure such as phlebotomy. In this context, external vibratory cold application and a marionette doll are a commonly used as non-pharmacological distraction method to reduce pain and fear. In the literature, there are studies with cold application, vibrating devices and a marionette doll in bee appearance therefor this study is aimed to evaluate the effect of bee-buzzy vibrating cold application and marionette doll on pain and fear during phlebotomy among preschool children.
Pain is one of the negative experiences faced in pediatric patients due to various medical interventions and often causes fear and anxiety. Pain perception is affected by the child's age, cognitive development, communication skills, previous pain experiences, and pain beliefs. Severe and long-term pain resulting from interventions can cause behavioral and physiological problems. In this period, if the pain is not alleviated or eliminated with appropriate interventions, it may cause neurological and behavioral disorders in the future. Nurses are responsible for minimizing the pain felt by children exposed to painful interventions and helping them cope with it .
Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
children who will receive bee-buzzy vibrating cold application
Other: bee-buzzy vibrating cold application marionette doll
children who will receive marionette doll
Other: bee-buzzy vibrating cold application marionette doll
children who will receive routine care
Other: Rotuine care
* Bee-buzzy will be attached to the arm of the preschool child (who is included in the bee-buzzy group) by the researchers, where the phlebotomy will be performed on the child. It reduces pain through its cold wings and vibration. It helps to distract attention during phlebotomy and reduces the feeling of pain and fear. Bee-buzzy will be tied 5 cm above the area from which blood will be drawn, and after waiting for 15 seconds, the nurse will perform a phlebotomy. * A marionette doll group; while the nurse is going to perform the phlebotomy operation on the preschool child, one of the researchers will try to distract the child by paly with marionette doll. The researchers will receive training in play therapy
Also known as: marionette doll
children in control group will receive routine hospital are
child pain
Facial expression rating scale (Wong-Baker Faces Pain Rating Scale). The Facial Expression Rating Scale includes 6 facial expressions and is a scale that provides a rating between 0 and 10 (Conlon, 2009; Huguet et al., 2010). Facial expressions range from"0" a smiling "brutal" face, 1-2 "It hurts a little", 3-4 "It hurts a little more", 5-6 "It hurts even more", 7-8 "It hurts a lot", and 9-10 "It hurts worst". This scale does not require words or numerical values and is a reliable and valid measurement tool in the assessment of acute pain. With this scale, the child's pain will be evaluated and recorded by both the nurse who will perform the phlebotomy and the parent.
Time frame: during phlebotomy
child fear
The "Children's Fear Scale" by McMurtry et al. (2011). This scale includes 5 different facial expressions. This scale is scored between 0 and 4 and it is stated to be a reliable and valid measurement tool in the evaluation of fear (McMurtry et al., 2011). The permission to use the scale was obtained by Binay and Bal Yılmaz (2019), and Turkish validity and reliability studies were conducted (Binay \& Bal Yılmaz, 2019; Binay \& Bal Yilmaz, 2022).
Time frame: during phlebotomy
Plan to share: No
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