Clinical trial

Efficacy of Procedural Information, Buzzy, and Multiple Interventions on Pain Management in Undergoing Venipuncture Children: A Randomised Controlled Trial

Name

BMERAL

Description

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.

Trial arms

Trial start

2021-09-01

Estimated PCD

2021-10-15

Trial end

2021-10-15

Status

Completed

Treatment

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.

Arms:

Procedural informational animation group

Buzzy

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.

Arms:

Buzzy group

Multiple interventions

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

Arms:

Multiple interventions group

Size

180

Primary endpoint

Pain assessment

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

Pain assessment

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

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Single (investigator)'}}, 'enrollmentInfo': {'count': 180, 'type': 'ACTUAL'}}

Updated at

2024-03-07

1 organization

1 product

5 indications

Organization

Karadeniz Technical University

Product

Multiple interventions

Indication

Indication

Indication

Indication

Indication