The Effect of Two Method to Reducing Pain and Fear During Draw Blood From Children

Study Overview
=================
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

Official Title
-----------------
The Effect of Two Different Applications on Reducing Pain and Fear During Draw Blood From Children

Conditions
-----------------
Pain, Procedural, Pain Management, Child, Only

Intervention / Treatment
-----------------
* Procedure: Bubble blowing method


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Experimental Group (ball squeezing) The group were used a ball squeezing method during the blood collection process. The children were given a ball during the blood draw and told to tighten and loosen it. | Procedure: Bubble blowing method<br>* The investigators were used Bubble blowing method and ball squeezing method. To child were used a ball squeezing method during the blood collection process.<br>* Other names: Ball squeezing method;|
| Active Comparator: Active Comparator<br>Active Comparator ( bubble blowing) The group were used a bubble blowing method during the blood collection process. During the blood collection process, the children were asked to blow bubbles by giving the apparatus inside the foam bubble to their free arm. | Procedure: Bubble blowing method<br>* The investigators were used Bubble blowing method and ball squeezing method. To child were used a ball squeezing method during the blood collection process.<br>* Other names: Ball squeezing method;|
| No Intervention: Control Group<br>No intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wong Baker Pain Faces Scale mean score | Wong-Baker Pain Faces Scale is widely used with people ages three and older, not limited to children. This self-assessment tool must be understood by the patient, so they are able to choose the face that best illustrates the physical pain they are experiencing. It is a tool to be used by a third person, parents, healthcare professionals, or caregivers, to assess the patient's pain. The scale is 0-10 scale. The six illustrated faces on the cards show a range of emotions, from a smiling face (0 'no pain) to a crying face (10 worst pain). 0 indicates no pain, 10 indicates the most severe pain. It defines the child's pain level before and after the blood collection. | First ten minute | 
| Children's Fear Scale mean score | Children's Fear Scale is a scale of 0-4 showing five faces ranging from a neutral expression (0 = no concern) to the feared face (4 = severe anxiety). A score of 0 indicates no fear and a score of 4 indicates extremely fearful. Defines the change of fear level before and after during the blood collection. | First ten minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, procedural, fear, child, distraction methods