Effect of Bee-buzzy Vibrating Cold Application and Marionette Doll on Pain and Fear During Phlebotomy
ConditionFear of Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
children and parents who agreed to participate in the study
children had successful phlebotomy in the first attempt.
Disqualifiers
Children who are having a chronic disease
Mental disability or mental retardation
Taking analgesics in the last 24 hours
Undergone a surgical procedure,
Trial design
Design model
Factorial
Treatments tested in this trial
bee-buzzy vibrating cold application marionette doll
Other intervention* 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
Rotuine care
Other interventionchildren in control group will receive routine hospital are
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: study group 1Experimental treatment 1 intervention
Group B: study group 2Active comparator 1 intervention
Group C: control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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 phlebotomySecondary outcomes
1
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 phlebotomySponsors and contacts
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Source ClinicalTrials.gov