Distraction and Nitrous Oxide for Venous Puncture

NCT04185233 | Completed

• 1 other identifier: in progress
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain; Venous Puncture

Keywords

nitrous oxide; distraction

Outcome Measures

Primary Outcomes (1)

• 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).

  From one hour prior to venous puncture until 1 hour afterwards

Secondary Outcomes (1)

• Pain score

  From one hour prior to venous puncture until 1 hour afterwards

Other Outcomes (1)

• Satisfaction score

  From time of venous puncture until 1 hour afterwards

Study Arms (2)

iPad distraction

EXPERIMENTAL

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

Nitrous Oxide

ACTIVE COMPARATOR

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

Interventions

Games on an iPad OTHER

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.

iPad distraction

Nitrous Oxide DRUG

Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one.

Nitrous Oxide

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva Children's Hospital

Geneva, 1206, Switzerland

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• Manon Cadoux, Student

  University of Geneva

  PRINCIPAL INVESTIGATOR

• Virginie Luscher, Student

  University of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: December 4, 2019
• Study Start: April 30, 2018
• Primary Completion: May 21, 2020
• Study Completion: September 30, 2020
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

CH (1)