NCT04199637

Brief Summary

The purpose of this study is to evaluate the effectiveness of therapeutic video game.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

November 19, 2019

Last Update Submit

March 22, 2023

Conditions

Childhood Lymphoblastic Lymphoma

Keywords

Acute lymphoblastic leukemiaTherapeutic Video gamesChildhood cancerPreschoolersAnxietyResisting behavior

Outcome Measures

Primary Outcomes (1)

  • 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.

    The continuous 8 weeks after recruiting

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group is provided therapeutic video games

Other: TVG

Control group

NO INTERVENTION

Control group is provided regular care

Interventions

TVGOTHER

Therapeutic video game

Experimental group

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ALL

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming University

Taipei, 11221, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 35994340DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaNeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesMental Disorders

Study Officials

  • IChing Hou, PhD

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 19, 2019

First Posted

December 16, 2019

Study Start

December 1, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)