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

June 5, 2024 updated by: Shimaa Hassan Khalf allah, Assiut University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Atyat M Hassan, post doctor

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut University Children Hospital
        • Contact:
          • shimaa h khalf allah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group 1
children who will receive bee-buzzy vibrating cold application
Other: bee-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
Other Names:
  • marionette doll
Active Comparator: study group 2
children who will receive marionette doll
Other: bee-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
Other Names:
  • marionette doll
Other: control group
children who will receive routine care
Other: Rotuine care
children in control group will receive routine hospital are

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during phlebotomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
child fear
Time Frame: during phlebotomy
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).
during phlebotomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Safaa R Osman, post doctor, Assiut university faculty of nursing
  • Study Chair: . Nahed T Mohamed, post doctor, Assiut university faculty of nursing
  • Study Director: Amira H Abdelfatah, post doctor, Assiut university faculty of nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2024

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • bee-buzzy&marionette doll

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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