Distraction and Nitrous Oxide for Venous Puncture (DISPO)
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|ClinicalTrials.gov Identifier: NCT04185233|
Recruitment Status : Completed
First Posted : December 4, 2019
Last Update Posted : January 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Pain Venous Puncture||Other: Games on an iPad Drug: Nitrous Oxide||Not Applicable|
The study is aiming at demonstrating the efficacy of active distraction by an iPad on the anxiety consequent to venipuncture and insertion of a peripheral vein catheter. The comparator is nitrous oxide in a 50% mixture with oxygen that is routinely used for sedation during procedural pain. However, nitrous oxide has secondary effects particularly on the inhibition of Vitamin B12.
The primary outcome is anxiety scores. Secondary outcomes are pain scores and satisfaction of parents and health providers.
All children will have EMLA cream (mixture prilocaine and lidocaine) applied one hour prior to venous punction. Anxiety, pain and satisfaction scores will be recorded at baseline and then within an hour following the venipuncture and insertion of the peripheral vein catheter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized clinical trial|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Comparison in Anxiety and Pain Scores Between Distraction and Nitrous Oxide for Procedural Pain in Children Aged 3 to 9 Years : a Randomized Clinical Trial|
|Actual Study Start Date :||April 30, 2018|
|Actual Primary Completion Date :||May 21, 2020|
|Actual Study Completion Date :||September 30, 2020|
Experimental: iPad distraction
Children of this group will receive the iPad when the nurse will prepare the material for the venous track. They will choose a game adapted to their age and will be able to play it during all the procedure time.
Intervention : game on iPad
Other: Games on an iPad
Many games will be programmed on the iPad and organized by age. The child will choose one game and play it during all the procedure time.
Active Comparator: Nitrous Oxide
Children of this group will receive the Nitrous Oxide 3 minutes before the intervention (venous track). They will keep the mask during all the procedure time.
Intervention : Nitrous Oxide
Drug: Nitrous Oxide
Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one.
- Anxiety score [ Time Frame: From one hour prior to venous puncture until 1 hour afterwards ]Anxiety level measured by a scale (modified Yale Preoperative Anxiety Scale) measured at baseline, during the venous puncture and one hour afterwards. The scale scores from a minimum of 5 (no anxiety) to 22 (extremely anxious).
- Pain score [ Time Frame: From one hour prior to venous puncture until 1 hour afterwards ]Pain intensity level will be measured at baseline, during the venous puncture and one hour afterwards, by a scale (Visual analog scale), which includes a score of 0 (no Pain) to 10 (worse pain).
- Satisfaction score [ Time Frame: From time of venous puncture until 1 hour afterwards ]Satisfaction of parents and care givers about the cares given to the child using a rating scale from 1(not satisfied at all) to 10 (extremely satisfied).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185233
|Geneva Children's Hospital|
|Geneva, Switzerland, 1206|
|Principal Investigator:||Manon Cadoux, Student||University of Geneva|
|Principal Investigator:||Virginie Luscher, Student||University of Geneva|