NCT01952106

Brief Summary

The main purpose of this study is Investigating the effectiveness of distraction by evaluating the children's perception of pain during venepuncture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 27, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

6 months

First QC Date

September 17, 2013

Last Update Submit

December 4, 2014

Conditions

Hospitalism in ChildrenPain

Keywords

venepuncturedistractiondistress

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue pain Scale will be used to evaluate children's pain perception

    monitor the children's oxygen saturation and pain scale.

    approximately 15 mins during venepuncture process

Study Arms (1)

distraction

EXPERIMENTAL

use the computer game to distract children's pain and anxiety during venepuncture

Other: play computer game

Interventions

play computer gameOTHER
distraction

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years old
  • understanding numeral

You may not qualify if:

  • mental retard and can not nuderstand numeral

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • chiying Tseng

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2013

First Posted

September 27, 2013

Study Start

October 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

TW(1)