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

NCT ID: NCT04199637

Last Updated: 2023-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-04-30

Brief Summary

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

Detailed Description

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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

Conditions

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Childhood Lymphoblastic Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Experimental group

Experimental group is provided therapeutic video games

Group Type EXPERIMENTAL

TVG

Intervention Type OTHER

Therapeutic video game

Control group

Control group is provided regular care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TVG

Therapeutic video game

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ALL

Exclusion Criteria

* non TPOG therapy
* without Port-A
* under PBST treatment
* ALL recurrent
* mental retardation
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

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I-Ching Hou

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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IChing Hou, PhD

Role: PRINCIPAL_INVESTIGATOR

National Yang Ming Chiao Tung University

Locations

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National Yang-Ming University

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 35994340 (View on PubMed)

Other Identifiers

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201705014RINC

Identifier Type: -

Identifier Source: org_study_id

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