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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2021-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Which Technique is Effective in Reducing the Pain of Peripheral Intravenous Catheterization in Pediatric Patients, Infra-Red Light or Buzzy®?

NCT05523518

Pain Management

UNKNOWN NA

Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children

NCT06841601

Pain Perception

RECRUITING NA

Effect of Cold Application and Vibration in Reducing Pain During Vaccination in Children

NCT06566378

Pain Pain, Acute Vaccination +3 more

COMPLETED NA

Effect of Guided Imagery Method on Procedural Pain in Children

NCT04978532

Procedural Pain Pain, Acute

COMPLETED NA

The Effect of the Helper Skin Tap Technique and Buzzy® During Vaccination

NCT06312228

Child, Only

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Procedural Child Phlebotomy Venipuncture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Single (investigator)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Procedural informational animation group

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.

Group Type EXPERIMENTAL

Providing procedural informational animation video

Intervention Type 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.

Buzzy group

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.

Group Type EXPERIMENTAL

Buzzy

Intervention Type 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.

Multiple interventions group

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.

Group Type EXPERIMENTAL

Multiple interventions

Intervention Type COMBINATION_PRODUCT

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type DEVICE

Multiple interventions

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes