Evaluation of Therapeutic Video Games for Pre-school Children With Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of therapeutic video game.

Detailed Description
-----------------
Children cancer was the third-ranked causes of children's death. During the long treatment courses, children are always forced to accept lots of drug therapy and invasive procedures without understanding the medical purpose. Due to the immature cognition, always lead to anxiety in childhood cancer patients. Our team developed a mobile technology platform based therapeutic video game (TVG) for preschoolers with acute lymphoblastic leukemia (ALL) in early 2018. Then three clinical experts were invited to validate TVG and had high appropriateness consensus. Then the pilot study was conducted in one medical center in Taipei and 10 preschoolers with ALL had been randomly signed in two groups-5 to intervention group (6 weeks game intervention) and 5 to control group (regular care). The preliminary results showed that crying scale and resisting behavior were no significance between two groups in the initial period (p=.663), but the intervention group showed lower crying grades and less resisting behavior than the control group in the final period (p=.028). The limitation of this pilot research was small sample size and short intervention time. Therefore, the purpose of this study is to increase the sample size and intervention time to evaluate the effectiveness of our TVG. Methods: A total of 68 fresh ALL preschool children will be randomized divided equally into intervention group and control group. Only intervention group

Official Title
-----------------
The Anxiety and Resisting Behavior Evaluation of Therapeutic Video Games for Pre-school Children With Acute Lymphoblastic Leukemia: Randomized Controlled Trial

Conditions
-----------------
Childhood Lymphoblastic Lymphoma

Intervention / Treatment
-----------------
* Other: TVG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALL Exclusion Criteria: non TPOG therapy without Port-A under PBST treatment ALL recurrent mental retardation

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Experimental group is provided therapeutic video games | Other: TVG<br>* Therapeutic video game<br>|
| No Intervention: Control group<br>Control group is provided regular care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of face pain rating scale | Face pain rating scale(0 means for no hurt; 10 means for hurts worst) is measured by participants' family after receiving invasive therapies for continuous 8 weeks after recruiting. | The continuous 8 weeks after recruiting | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute lymphoblastic leukemia, Therapeutic Video games, Childhood cancer, Preschoolers, Anxiety, Resisting behavior