Clinical trial NCT05064657: The Effect of Two Method to Reducing Pain and Fear During Draw Blood From Children
Official title: The Effect of Two Different Applications on Reducing Pain and Fear During Draw Blood From Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Procedural
Pain Management
Child, Only
Keywords: pain
procedural
fear
child
distraction methods
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 111
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment First sub purpose was designed as parallel group, two intervention groups in pre-test and post-test order, and a randomized controlled control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to evaluate the effects of two different distraction methods on reducing pain and fear during blood collection from children.

The study was conducted between January 2020 and May 2021.

Detailed description: The study was a pretest-posttest, parallel group randomized controlled experimental design.

H0: The pain and fear mean scores of the intervention group, in which the distraction method (ball squeezing and blowing bubbles) was applied during the blood collection process, was not different from the control group.

The study was carried out with the participation of 111 children aged 6-12 years and their parents, who underwent blood collection in the emergency department of a state hospital.

Children were randomly assigned to blowing bubbles (n:37), ball squeezing (n:37) and control (n:37) groups. Bubble blowing and ball squeezing methods were used to distract attention during the blood collection process. Data were collected with Child and Family Information Form, Wong Baker Faces Pain Scale, Child Fear Scale. Pretest and posttest measurements were recorded separately by the child, parent and researcher. Descriptive statistics, Chi-square test, one-way analysis of variance, Tamhane's T2 test, t test for dependent groups were used in the analysis of the data. The statistical significance of the results was taken as p\<0,05

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 6-12
* The child's willingness to voluntarily participate in the study
* Parent's willingness to participate in the study voluntarily
* Parent and child can speak Turkish

Exclusion Criteria:

* The child has a disease that causes chronic pain
* The child has a hearing or visual impairment
* The child has a mental or neurological disability
* The child has used drugs that will create an analgesic effect in the last 24 hours before the application

Primary outcomes:
measure: Wong Baker Pain Faces Scale mean score
timeFrame: First ten minute
measure: Children's Fear Scale mean score
timeFrame: First ten minute
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
affiliation: Selcuk University
name: Fatma Tas Arslan, Prof.
role: STUDY_DIRECTOR
affiliation: Selcuk University
name: Neşe Oluç, Msc
role: PRINCIPAL_INVESTIGATOR
References: