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Trial record 3 of 6 for:    DISPO

Distraction and Nitrous Oxide for Venous Puncture (DISPO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04185233
Recruitment Status : Completed
First Posted : December 4, 2019
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Walid HABRE, University Hospital, Geneva

Brief Summary:
This study will compare the efficiency of the iPad distraction or the administration of Nitrous Oxide on the anxiety decrease when a peripheral venous catheter is needed in children between 3 and 9 years old.

Condition or disease Intervention/treatment Phase
Anxiety Pain Venous Puncture Other: Games on an iPad Drug: Nitrous Oxide Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Venous track needed
  • French mother tongue
  • Age between 3 and 9 years old

Exclusion Criteria:

  • Children with cognitive disorder (autism, metabolic disorders,
  • Children with cerebral-motor disability
  • Children who don't speak french
  • Children with ADHD treatment
  • Children with epilepsy
  • Children who present contraindication to the use of Nitrous oxide

Information from the National Library of Medicine

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


Locations
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Switzerland
Geneva Children's Hospital
Geneva, Switzerland, 1206
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Manon Cadoux, Student University of Geneva
Principal Investigator: Virginie Luscher, Student University of Geneva
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Responsible Party: Walid HABRE, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT04185233    
Other Study ID Numbers: in progress
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Walid HABRE, University Hospital, Geneva:
nitrous oxide
distraction
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents