Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture

Study Overview
=================
Brief Summary
-----------------
Venipuncture is one of the most common stressful procedures in children. Managing pain and fear of venipuncture procedure recommended strongly because it may change children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses. There was clear evidence that the distraction method is the most performed as a psychological technique performed to decrease venipuncture-related pain and distress and supporting its efficacy in children. The aim of this study to investigate the effectiveness of TICK-B on children's pain and anxiety during venipuncture procedure.

Detailed Description
-----------------
Note: The first registration number for the protocol of Ph.D. was approved as 10092019-6 on 10th September 2019 It approved the grant to publish the result as 20072020-3 on 23, August,

Official Title
-----------------
The Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture in a Pediatric Department: A Randomized Controlled Trial

Conditions
-----------------
Venipuncture, Pain, Anxiety, Fear

Intervention / Treatment
-----------------
* Other: Trace Image and Coloring for Kids-Book (TICK-B)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being between 6-12 years old, a physician order was placed for the blood sample, Exclusion Criteria: Chronic medical condition. Those whose parent not participated, Neurodevelopmental delayed, verbal difficulties, difficulties in hearing or visual, Unconsciousness. Take a medication analgesic in the past 6 hrs. history of syncope.

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

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TICK-B group as Intervention group<br>Experimental: TICK-B group -Pediatric patients received TICK-B as a distraction in the TICK-B group | Other: Trace Image and Coloring for Kids-Book (TICK-B)<br>* A collection of pictures designed as a book contains and given to children during the procedure and they take a picture as they favored.<br>|
| No Intervention: Standard care provided group as control group<br>-Pediatric patients received standard care (routine care) in the control group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Measure | Wong-Baker faces scale (WBFS). Used to measure the pain severity during the procedure, the WB-FBRS is a series of six cartoon faces positioned side-by-side from the greatest pain to the mildest one (0-5). | Immediately after venipuncture (1-2 min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear Measure | The Childrens Fear Scale (CFS) is used to assess children's fear or anxiety levels. The one-item scale consists of five sex neutral faces arranged from left to right with no fear in the center, through fear out to extreme fear. | Immediately after venipuncture (1-2 min. ) |