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Clinical Trials/NCT04199637
NCT04199637
Completed
Not Applicable

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

National Yang Ming Chiao Tung University1 site in 1 country15 target enrollmentDecember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childhood Lymphoblastic Lymphoma
Sponsor
National Yang Ming Chiao Tung University
Enrollment
15
Locations
1
Primary Endpoint
The change of face pain rating scale
Status
Completed
Last Updated
3 years ago

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

Registry
clinicaltrials.gov
Start Date
December 1, 2019
End Date
April 30, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

I-Ching Hou

Assistant Professor

National Yang Ming Chiao Tung University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

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.

Study Sites (1)

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