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

March 5, 2024 updated by: Buket MERAL, Karadeniz Technical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bayburt, Turkey
        • Bayburt University/Faculty of Health Sciences
      • Ordu, Turkey
        • Ordu University/Faculty of Medicine
      • Trabzon, Turkey
        • Karadeniz Technical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: 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.
Experimental: 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.
Device: 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.
Experimental: 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.
Combination product: Multiple interventions
Watching procedural informational animation video prior to venipuncture, and Buzzy application during venipuncture
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: The pain was measured at 30 seconds after (immediately) 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."
The pain was measured at 30 seconds after (immediately) the venipuncture.
Pain assessment
Time Frame: 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."
The pain was measured at 2-3 minutes after the venipuncture.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain assessment - parent
Time Frame: The pain was measured at 30 seconds after (immediately) 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."
The pain was measured at 30 seconds after (immediately) the venipuncture by parent
Pain assessment - parent
Time Frame: 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."
The pain was measured at 2-3 minutes after the venipuncture by parent
Pain assessment - nurse
Time Frame: The pain was measured at 30 seconds after (immediately) 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."
The pain was measured at 30 seconds after (immediately) the venipuncture by nurse.
Pain assessment - nurse
Time Frame: 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."
The pain was measured at 2-3 minutes after the venipuncture by nurse.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BMERAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

IPD Sharing Time Frame

12 months after publication

IPD Sharing Access Criteria

Relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings