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Clinical Trials/NCT06443437
NCT06443437
Recruiting
N/A

Effect of Bee-buzzy Vibrating Cold Application and Marionette Doll on Pain and Fear During Phlebotomy Among Preschool Children: A Randomized Controlled Study

Assiut University1 site in 1 country90 target enrollmentMay 31, 2024
ConditionsFear of Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fear of Pain
Sponsor
Assiut University
Enrollment
90
Locations
1
Primary Endpoint
child pain
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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 .

Registry
clinicaltrials.gov
Start Date
May 31, 2024
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shimaa Hassan Khalf allah

lecturer

Assiut University

Eligibility Criteria

Inclusion Criteria

  • children and parents who agreed to participate in the study
  • children had successful phlebotomy in the first attempt.

Exclusion Criteria

  • Children who are having a chronic disease
  • Mental disability or mental retardation
  • Taking analgesics in the last 24 hours
  • Undergone a surgical procedure,
  • Not having a successful phlebotomy on the first attempt,
  • The child and his/her family not being willing to participate in the study.

Outcomes

Primary Outcomes

child pain

Time Frame: during phlebotomy

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.

Secondary Outcomes

  • child fear(during phlebotomy)

Study Sites (1)

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