Hospitalism in ChildrenNCT01952106
Effects of Distraction on Pain and Distress During Venepuncture in Children
A study testing play computer game in people with Hospitalism in Children and Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The main purpose of this study is Investigating the effectiveness of distraction by evaluating the children's perception of pain during venepuncture. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Hospitalism in Children, Pain
- What is being tested?
- play computer game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 5-7 years old
- understanding numeral
Who cannot join
- mental retard and can not nuderstand numeral
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is Investigating the effectiveness of distraction by evaluating the children's perception of pain during venepuncture.
- Conditions
- Hospitalism in Children, Pain
- Being tested
- play computer game
- Keywords
- venepuncture, distraction, distress
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
play computer gameOther
| Study group | Role | What they receive |
|---|---|---|
| distraction | Experimental | use the computer game to distract children's pain and anxiety during venepuncture Receives: Other: play computer game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue pain Scale will be used to evaluate children's pain perception
monitor the children's oxygen saturation and pain scale.
Measured: approximately 15 mins during venepuncture process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalism in ChildrenStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- chiying Tseng, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952106
- Sponsor's protocol ID
- 201305092RIND
- Status last verified
- Dec 2014
- First submitted
- 17 Sep 2013
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Distraction on Pain and Distress During Venepuncture in Children
- ClinicalTrials.gov ID
- NCT01952106
- Acronym / sponsor ID
- 201305092RIND
- Conditions
- Hospitalism in Children, Pain
- Keywords
- venepuncture, distraction, distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 27 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is Investigating the effectiveness of distraction by evaluating the children's perception of pain during venepuncture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| distraction | Experimental | Other: play computer gameuse the computer game to distract children's pain and anxiety during venepuncture |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 5-7 years old
- understanding numeral
Key exclusion criteria (1 listed)
- mental retard and can not nuderstand numeral
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| play computer game | Other | distraction |
Primary outcome
Visual Analogue pain Scale will be used to evaluate children's pain perception
Time frame: approximately 15 mins during venepuncture process
monitor the children's oxygen saturation and pain scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
Related trials for Hospitalism in Children
Recruiting
Mindfulness-Based Emotion Regulation Training for Hospitalized Children
Fear, Child, Only
Not yet recruiting
IVC Collapsibility Index or CVP as a Predictor of Fluid Responsiveness in Pediatric Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
chiying Tseng principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing play computer game in people with Hospitalism in Children and Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue pain Scale will be used to evaluate children's pain perception (time frame: approximately 15 mins during venepuncture process). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.