Clinical trial NCT05374902: Efficacy of Animation, Buzzy, and Multiple Interventions on Pain in Children
Official title: Efficacy of Procedural Information, Buzzy, and Multiple Interventions on Pain Management in Undergoing Venipuncture Children: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Procedural
Child
Phlebotomy
Venipuncture
Keywords: procedural pain
child
phlebotomy
venipunctur
animation
nursing practice
Non-pharmacological method
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Pain assessment
timeFrame: The pain was measured at 30 seconds after (immediately) the venipuncture.
measure: Pain assessment
timeFrame: The pain was measured at 2-3 minutes after the venipuncture.
Secondary outcomes:
measure: Pain assessment - parent
timeFrame: The pain was measured at 30 seconds after (immediately) the venipuncture by parent
measure: Pain assessment - parent
timeFrame: The pain was measured at 2-3 minutes after the venipuncture by parent
measure: Pain assessment - nurse
timeFrame: The pain was measured at 30 seconds after (immediately) the venipuncture by nurse.
measure: Pain assessment - nurse
timeFrame: The pain was measured at 2-3 minutes after the venipuncture by nurse.
Other outcomes:
Locations:
city: Bayburt
country: Turkey
facility: Bayburt University/Faculty of Health Sciences
city: Ordu
country: Turkey
facility: Ordu University/Faculty of Medicine
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
References: