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

NCT06443437 | Recruiting

• 1 other identifier: bee-buzzy&marionette doll
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Fear of Pain

Outcome Measures

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.

  during phlebotomy

Secondary Outcomes (1)

• child fear

  during phlebotomy

Study Arms (3)

study group 1

EXPERIMENTAL

children who will receive bee-buzzy vibrating cold application

Other: bee-buzzy vibrating cold application marionette doll

study group 2

ACTIVE COMPARATOR

children who will receive marionette doll

Other: bee-buzzy vibrating cold application marionette doll

control group

OTHER

children who will receive routine care

Other: Rotuine care

Interventions

bee-buzzy vibrating cold application marionette doll OTHER

* 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

study group 1; study group 2

Rotuine care OTHER

children in control group will receive routine hospital are

control group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university children hospital

Asyut, Egypt

RECRUITING

Related Publications (6)

• Yildirim BG, Gerceker GO. The Effect of Virtual Reality and Buzzy on First Insertion Success, Procedure-Related Fear, Anxiety, and Pain in Children during Intravenous Insertion in the Pediatric Emergency Unit: A Randomized Controlled Trial. J Emerg Nurs. 2023 Jan;49(1):62-74. doi: 10.1016/j.jen.2022.09.018. Epub 2022 Nov 12.

  PMID: 36376127 BACKGROUND

• Wang Y, Guo L, Xiong X. Effects of Virtual Reality-Based Distraction of Pain, Fear, and Anxiety During Needle-Related Procedures in Children and Adolescents. Front Psychol. 2022 Apr 19;13:842847. doi: 10.3389/fpsyg.2022.842847. eCollection 2022.

  PMID: 35519646 BACKGROUND

• Ugucu G, Akdeniz Uysal D, Guzel Polat O, Artuvan Z, Polat Kulcu D, Aksu D, Gulgun Altintas M, Cetin H, Orekici Temel G. Effects of cartoon watching and bubble-blowing during venipuncture on pain, fear, and anxiety in children aged 6-8 years: A randomized experimental study. J Pediatr Nurs. 2022 Jul-Aug;65:e107-e114. doi: 10.1016/j.pedn.2022.03.016. Epub 2022 Apr 8.

  PMID: 35410736 BACKGROUND

• Turgut MA, Turkmen AS. The effect of lighted toy on reducing pain and fear during blood collection in children between 3 and 6 years: A randomized control trial. J Pediatr Nurs. 2023 May-Jun;70:111-116. doi: 10.1016/j.pedn.2023.02.009. Epub 2023 Mar 9.

  PMID: 36905910 BACKGROUND

• McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.

  PMID: 21806301 BACKGROUND

• Kuo HC, Pan HH, Creedy DK, Tsao Y. Distraction-Based Interventions for Children Undergoing Venipuncture Procedures: A Randomized Controlled Study. Clin Nurs Res. 2018 May;27(4):467-482. doi: 10.1177/1054773816686262. Epub 2016 Dec 30.

  PMID: 28038497 BACKGROUND

Study Officials

• Safaa R Osman, post doctor

  Assiut university faculty of nursing

  STUDY CHAIR

• . Nahed T Mohamed, post doctor

  Assiut university faculty of nursing

  STUDY CHAIR

• Amira H Abdelfatah, post doctor

  Assiut university faculty of nursing

  STUDY DIRECTOR

Central Study Contacts

Shimaa H Khalf allah, post doctor

CONTACT

01097248758; shimaa_hassan@aun.edu.eg

Atyat M Hassan, post doctor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: May 31, 2024
• Primary Completion: June 15, 2024
• Study Completion: June 30, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)