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Effect of Bee-buzzy Vibrating Cold Application and Marionette Doll on Pain and Fear During Phlebotomy

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06443437
Enrollment
90
Registered
2024-06-05
Start date
2024-05-31
Completion date
2024-06-30
Last updated
2024-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fear of Pain

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 .

Interventions

OTHERbee-buzzy vibrating cold application marionette doll

* 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

OTHERRotuine care

children in control group will receive routine hospital are

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes

Inclusion criteria

1. children and parents who agreed to participate in the study 2. children had successful phlebotomy in the first attempt.

Exclusion criteria

1. Children who are having a chronic disease 2. Mental disability or mental retardation 3. Taking analgesics in the last 24 hours 4. Undergone a surgical procedure, 5. Not having a successful phlebotomy on the first attempt, 6. The child and his/her family not being willing to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
child painduring phlebotomyFacial 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 from0 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

MeasureTime frameDescription
child fearduring phlebotomyThe 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).

Countries

Egypt

Contacts

Primary ContactShimaa H Khalf allah, post doctor
shimaa_hassan@aun.edu.eg01097248758
Backup ContactAtyat M Hassan, post doctor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026