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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04199637
Enrollment
15
Registered
2019-12-16
Start date
2019-12-01
Completion date
2020-04-30
Last updated
2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Lymphoblastic Lymphoma

Keywords

Acute lymphoblastic leukemia, Therapeutic Video games, Childhood cancer, Preschoolers, Anxiety, Resisting behavior

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

Interventions

OTHERTVG

Therapeutic video game

Sponsors

National Yang Ming Chiao Tung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
No

Inclusion criteria

* ALL

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
The change of face pain rating scaleThe continuous 8 weeks after recruitingFace 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026