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Spots Global Cancer Trial Database for Evaluation of Therapeutic Video Games for Pre-school Children With Acute Lymphoblastic Leukemia

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Trial Identification

Brief Title: 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 ID: NCT04199637

Interventions

TVG

Study Description

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

Minimum Age: 3 Years

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: No

Locations

National Yang-Ming University, Taipei, , Taiwan

Contact Details

Name: IChing Hou, PhD

Affiliation: National Yang Ming Chiao Tung University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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