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

Not Applicable

Completed

• Conditions: Childhood Lymphoblastic Lymphoma
• Interventions: Other: TVG

• Registration Number: NCT04199637
• Lead Sponsor: National Yang Ming Chiao Tung University

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

Study Timeline

• Study First Submitted: 2019-11-19
• Study Start: 2019-12-01
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-16
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• ALL

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	TVG	Experimental group is provided therapeutic video games

Primary Outcome Measures

Name	Time	Method
The change of face pain rating scale	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.

Trial Locations

Locations (1)

National Yang-Ming University; 🇨🇳 Taipei, Taiwan