search
Back to results

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

Primary Purpose

Childhood Lymphoblastic Lymphoma

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
TVG
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Childhood Lymphoblastic Lymphoma focused on measuring Acute lymphoblastic leukemia, Therapeutic Video games, Childhood cancer, Preschoolers, Anxiety, Resisting behavior

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ALL

Exclusion Criteria:

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

Sites / Locations

  • National Yang-Ming University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Experimental group is provided therapeutic video games

Control group is provided regular care

Outcomes

Primary Outcome Measures

The change of face pain rating scale
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.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2019
Last Updated
March 22, 2023
Sponsor
National Yang Ming University
search

1. Study Identification

Unique Protocol Identification Number
NCT04199637
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 Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Lymphoblastic Lymphoma
Keywords
Acute lymphoblastic leukemia, Therapeutic Video games, Childhood cancer, Preschoolers, Anxiety, Resisting behavior

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental group is provided therapeutic video games
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group is provided regular care
Intervention Type
Other
Intervention Name(s)
TVG
Intervention Description
Therapeutic video game
Primary Outcome Measure Information:
Title
The change of face pain rating scale
Description
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.
Time Frame
The continuous 8 weeks after recruiting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ALL Exclusion Criteria: non TPOG therapy without Port-A under PBST treatment ALL recurrent mental retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IChing Hou, PhD
Organizational Affiliation
National Yang Ming University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
ZIP/Postal Code
11221
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35994340
Citation
Yang DJ, Lu MY, Chen CW, Liu PC, Hou IC. Development of a Therapeutic Video Game With the MDA Framework to Decrease Anxiety in Preschool-Aged Children With Acute Lymphoblastic Leukemia: Mixed Methods Approach. JMIR Serious Games. 2022 Aug 22;10(3):e37079. doi: 10.2196/37079. Erratum In: JMIR Serious Games. 2022 Oct 5;10(4):e43211.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs