Clinical trial NCT04199637: Evaluation of Therapeutic Video Games for Pre-school Children With Acute Lymphoblastic Leukemia
Official title: The Anxiety and Resisting Behavior Evaluation of Therapeutic Video Games for Pre-school Children With Acute Lymphoblastic Leukemia: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Lymphoblastic Lymphoma
Keywords: Acute lymphoblastic leukemia
Therapeutic Video games
Childhood cancer
Preschoolers
Anxiety
Resisting behavior
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 15
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: Inclusion Criteria:

* ALL

Exclusion Criteria:

* non TPOG therapy
* without Port-A
* under PBST treatment
* ALL recurrent
* mental retardation

Primary outcomes:
measure: The change of face pain rating scale
timeFrame: The continuous 8 weeks after recruiting
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: IChing Hou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang DJ, Lu MY, Chen CW, Liu PC, Hou IC. Development of a Therapeutic Video Game With the MDA Framework to Decrease Anxiety in Preschool-Aged Children With Acute Lymphoblastic Leukemia: Mixed Methods Approach. JMIR Serious Games. 2022 Aug 22;10(3):e37079. doi: 10.2196/37079.