Evaluation of Therapeutic Video Games f… | Clinical Trial

Key information

Conditions

Childhood Lymphoblastic Lymphoma Anxiety Disorders Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang-Ming University

Taipei, 11221, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ALL

Exclusion criteria

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

Treatment and study plan

TVG

Other

Therapeutic video game

Primary outcomes

The change of face pain rating scale

Time frame: The continuous 8 weeks after recruiting

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.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Dec 16, 2019
Registry last updated: Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed