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

Not Applicable

Completed

• Conditions: Pain, Procedural; Venipuncture; Child; Phlebotomy
• Interventions: Device: Buzzy; Combination Product: Multiple interventions; Other: Providing procedural informational animation video

• Registration Number: NCT05374902
• Lead Sponsor: Karadeniz Technical University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-15
• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buzzy group	Buzzy	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.
Multiple interventions group	Multiple interventions	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.
Procedural informational animation group	Providing procedural informational animation video	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.

Primary Outcome Measures

Name	Time	Method
Pain assessment	The pain was measured at 2-3 minutes after the venipuncture.	Pain intensity was assessed Wong-Baker FACES Pain Rating Scale. It is used to determine the pain level of children aged between 3 and 18 years through their facial expressions which are assigned the values of 0 and 10. The first face represents a pain score of 0, and indicates "no hurt". The last face represents a pain score of 10, and indicates "hurts worst."

Secondary Outcome Measures

Name	Time	Method
Pain assessment - parent	The pain was measured at 2-3 minutes after the venipuncture by parent	Pain intensity was assessed Wong-Baker FACES Pain Rating Scale. It is used to determine the pain level of children aged between 3 and 18 years through their facial expressions which are assigned the values of 0 and 10. The first face represents a pain score of 0, and indicates "no hurt". The last face represents a pain score of 10, and indicates "hurts worst."
Pain assessment - nurse	The pain was measured at 2-3 minutes after the venipuncture by nurse.	Pain intensity was assessed Wong-Baker FACES Pain Rating Scale. It is used to determine the pain level of children aged between 3 and 18 years through their facial expressions which are assigned the values of 0 and 10. The first face represents a pain score of 0, and indicates "no hurt". The last face represents a pain score of 10, and indicates "hurts worst."

Trial Locations

Locations (3)

Bayburt University/Faculty of Health Sciences; 🇹🇷 Bayburt, Turkey

Ordu University/Faculty of Medicine; 🇹🇷 Ordu, Turkey

Karadeniz Technical University; 🇹🇷 Trabzon, Turkey