search
Back to results

Efficacy of Animation, Buzzy, and Multiple Interventions on Pain in Children: A Randomised Controlled Trial

Primary Purpose

Pain, Procedural, Child, Phlebotomy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Providing procedural informational animation video
Buzzy
Multiple interventions
Sponsored by
Karadeniz Technical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Procedural focused on measuring procedural pain, child, phlebotomy, venipunctur, animation, nursing practice, Non-pharmacological method

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Procedural informational animation group

Buzzy group

Multiple interventions group

Control group

Arm Description

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® 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.

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.

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

Outcomes

Primary Outcome Measures

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."
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."

Secondary Outcome Measures

Pain assessment - 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 - 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
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
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."

Full Information

First Posted
April 19, 2022
Last Updated
May 10, 2022
Sponsor
Karadeniz Technical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05374902
Brief Title
Efficacy of Animation, Buzzy, and Multiple Interventions on Pain in Children: A Randomised Controlled Trial
Official Title
Efficacy of Procedural Information, Buzzy, and Multiple Interventions on Pain Management in Undergoing Venipuncture Children: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karadeniz Technical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural, Child, Phlebotomy, Venipuncture
Keywords
procedural pain, child, phlebotomy, venipunctur, animation, nursing practice, Non-pharmacological method

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Single (investigator)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Procedural informational animation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Buzzy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Multiple interventions group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Providing procedural informational animation video
Intervention Description
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
Device
Intervention Name(s)
Buzzy
Intervention Description
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
Combination Product
Intervention Name(s)
Multiple interventions
Intervention Description
Watching procedural informational animation video prior to venipuncture, and Buzzy application during venipuncture
Primary Outcome Measure Information:
Title
Pain assessment
Description
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."
Time Frame
The pain was measured at 30 seconds after (immediately) the venipuncture.
Title
Pain assessment
Description
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."
Time Frame
The pain was measured at 2-3 minutes after the venipuncture.
Secondary Outcome Measure Information:
Title
Pain assessment - parent
Description
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."
Time Frame
The pain was measured at 30 seconds after (immediately) the venipuncture by parent
Title
Pain assessment - parent
Description
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."
Time Frame
The pain was measured at 2-3 minutes after the venipuncture by parent
Title
Pain assessment - nurse
Description
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."
Time Frame
The pain was measured at 30 seconds after (immediately) the venipuncture by nurse.
Title
Pain assessment - nurse
Description
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."
Time Frame
The pain was measured at 2-3 minutes after the venipuncture by nurse.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Bayburt University/Faculty of Health Sciences
City
Bayburt
Country
Turkey
Facility Name
Ordu University/Faculty of Medicine
City
Ordu
Country
Turkey
Facility Name
Karadeniz Technical University
City
Trabzon
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Efficacy of Animation, Buzzy, and Multiple Interventions on Pain in Children: A Randomised Controlled Trial

We'll reach out to this number within 24 hrs