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Efficacy of Animation, Buzzy, and Multiple Interventions on Pain in Children

K

Karadeniz Technical University

Status

Completed

Conditions

Child
Phlebotomy
Pain, Procedural
Venipuncture

Treatments

Device: Buzzy
Combination Product: Multiple interventions
Other: Providing procedural informational animation video

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The aim of the study was to determine the effects of providing procedural informational animation, Buzzy application during the procedure, the combination of both interventions (Animated video and Buzzy), and standard care on pain management during venipuncture in children aged 6-12 years.

Full description

A prospective randomized controlled trial design was used to determine the effects of Buzzy, procedural informational animation, multiple interventions (Buzzy and Animated video), and standard care on the pain level of 6-12 years aged children during venıpunctrue. The study was conducted in the territory hospital pediatric blood collection unit The sample size was determined by power analysis and 45 child-parent pairs were included in each group. The patients who met the sample selection criteria were randomly and equally assigned into 4 groups using a computer-based program. As a data collection tools, Data Collection Form and Wong-Baker have been used. Venipuncture-related pain was self-reported by each child, as well as through parents and nurse. Children in the multiple interventions group were shown procedural informative animation and the venipunctıre procedure was performed with buzzy®. Standard care was applied to the control group, in which no local anesthetic was used and families could accompany the bloodletting process. The pain responses of the children were evaluated twice, immediately after the procedure (while the child was sitting in the blood collection chair) and 2-3 minutes after the procedure, both by the children's self-reports and by the parents and the nurse.

Enrollment

180 patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • being between the ages of 6 and 12 years,
  • admitted to the hospital as an outpatient,
  • having complete skin integrity at the place where the Buzzy device will be inserted
  • having the ability to verbally communicate
  • parents being literate.

Exclusion criteria

  • having any acute pain at the time of the procedure
  • having any audiovisual, cognitive sensitivity, or physical disability and having a chronic or life-threatening disease
  • being under the influence of any sedative/anticonvulsant/analgesic drug,
  • getting blood drawn in the last month
  • failure to phlebotomy at the first attempt
  • having nerve damage or peripheral neuropathy.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 4 patient groups

Procedural informational animation group
Experimental group
Description:
Children and parents have watched procedural informational animation before venipuncture. Afterward, the children and their parents entered the blood drawn unit, and the procedure was performed as in standard care.
Treatment:
Other: Providing procedural informational animation video
Buzzy group
Experimental group
Description:
Buzzy® was placed on the injection site and cold application and vibration were turned on 60 s before the procedure. Then, the nurse moved Buzzy® about 3-5 cm above the injection site. The procedure was performed with buzzy®. The Buzzy® intervention and phlebotomy were terminated at the same time.
Treatment:
Device: Buzzy
Multiple interventions group
Experimental group
Description:
Children and parents have watched procedural informational animation before venipuncture. Afterward, the children and their parents entered the blood drawn unit. Buzzy® was placed on the injection site and cold application and vibration were turned on 60 s before the procedure. Then, the nurse moved Buzzy® about 3-5 cm above the injection site. The procedure was performed with buzzy®. The Buzzy® intervention and phlebotomy were terminated at the same time.
Treatment:
Combination Product: Multiple interventions
Control group
No Intervention group
Description:
Children in this group received standard care. A local anesthetic is not used, and the parents are with their children during the procedure in the standard care of the blood collection unit

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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