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Distraction and Nitrous Oxide for Venous Puncture (DISPO)

Primary Purpose

Anxiety, Pain, Venous Puncture

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Games on an iPad
Nitrous Oxide
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety focused on measuring nitrous oxide, distraction

Eligibility Criteria

3 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Geneva Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iPad distraction

Nitrous Oxide

Arm Description

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

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

Outcomes

Primary Outcome Measures

Anxiety score
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

Pain score
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).

Full Information

First Posted
May 9, 2019
Last Updated
January 5, 2021
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT04185233
Brief Title
Distraction and Nitrous Oxide for Venous Puncture
Acronym
DISPO
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
May 21, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain, Venous Puncture
Keywords
nitrous oxide, distraction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iPad distraction
Arm Type
Experimental
Arm Description
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
Arm Title
Nitrous Oxide
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Games on an iPad
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nitrous Oxide
Intervention Description
Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one.
Primary Outcome Measure Information:
Title
Anxiety score
Description
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).
Time Frame
From one hour prior to venous puncture until 1 hour afterwards
Secondary Outcome Measure Information:
Title
Pain score
Description
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).
Time Frame
From one hour prior to venous puncture until 1 hour afterwards
Other Pre-specified Outcome Measures:
Title
Satisfaction score
Description
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).
Time Frame
From time of venous puncture until 1 hour afterwards

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manon Cadoux, Student
Organizational Affiliation
University of Geneva
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Virginie Luscher, Student
Organizational Affiliation
University of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva Children's Hospital
City
Geneva
ZIP/Postal Code
1206
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Distraction and Nitrous Oxide for Venous Puncture

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