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

NCT05374902 | Completed

• 1 other identifier: BMERAL
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

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.

Conditions

Pain, Procedural; Child; Phlebotomy; Venipuncture

Keywords

procedural pain; child; phlebotomy; venipunctur; animation; nursing practice; Non-pharmacological method

Outcome Measures

Primary Outcomes (2)

• Pain assessment

  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."

  The pain was measured at 30 seconds after (immediately) the venipuncture.

• Pain assessment

  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."

  The pain was measured at 2-3 minutes after the venipuncture.

Secondary Outcomes (4)

• Pain assessment - parent

  The pain was measured at 30 seconds after (immediately) the venipuncture by parent

• Pain assessment - parent

  The pain was measured at 2-3 minutes after the venipuncture by parent

• Pain assessment - nurse

  The pain was measured at 30 seconds after (immediately) the venipuncture by nurse.

• Pain assessment - nurse

  The pain was measured at 2-3 minutes after the venipuncture by nurse.

Study Arms (4)

Procedural informational animation group

EXPERIMENTAL

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.

Other: Providing procedural informational animation video

Buzzy group

EXPERIMENTAL

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.

Device: Buzzy

Multiple interventions group

EXPERIMENTAL

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.

Combination Product: Multiple interventions

Control group

NO INTERVENTION

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

Interventions

Providing procedural informational animation video OTHER

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.

Procedural informational animation group

Buzzy DEVICE

Buzzy® was placed on the injection site and it was 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.

Buzzy group

Multiple interventions COMBINATION_PRODUCT

Watching procedural informational animation video prior to venipuncture, and Buzzy application during venipuncture

Multiple interventions group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (3)

Bayburt University/Faculty of Health Sciences

Bayburt, Turkey (Türkiye)

Location

Ordu University/Faculty of Medicine

Ordu, Turkey (Türkiye)

Location

Karadeniz Technical University

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Single (investigator)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asistant

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 16, 2022
• Study Start: September 1, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 12 months after publication
• Access Criteria: Relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

TU (3)