NCT03941717

Testing the Effectiveness of a Parent and Child Mindfulness-Based Intervention for Child Venipuncture

Completed NA Last updated 1 June 2022

What this trial tests

NA trial testing Mindfulness-Based Condition in Pain in 61 participants. Completed in 13 March 2020.

Timeline

4 October 2019

Primary endpoint
13 March 2020

13 March 2020

Quick facts

Lead sponsor	University of Guelph
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	61
Start date	4 October 2019
Primary completion	13 March 2020
Estimated completion	13 March 2020
Sites	1 location across Canada

Drugs / interventions tested

• Mindfulness-Based Condition
• Unfocused attention Condition

Conditions studied

• Pain — all drugs for Pain →
• Needle Stick — all drugs for Needle Stick →

Sponsor

University of Guelph

Who can join

Adults 7 to 12, any sex, with Pain or Needle Stick. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study investigates the impact of mindfulness-based intervention for children undergoing a blood-draw and their accompanying parent on (a) child ratings of pain and fear, (b) parent and child ratings of parent distress, and (c) parent perceptions of child pain and fear. Half of the parent-child pairs will receive the mindfulness-based intervention, while half will receive an unfocused-attention task to serve as a comparison with no active component.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Study protocol for a randomized controlled trial of a child and parent mindfulness intervention for pediatric venipuncture.
   Moline RL, Chambers C, McMurtry CM. · · 2021 · cited 7× · PMID 35548848 · DOI 10.1002/pne2.12038
2. Biopsychosocial Contributors to Parent Behaviors during Child Venipuncture.
   Constantin KL, Moline RL, Pillai Riddell R, Spence JR, et al · · 2022 · cited 5× · PMID 35883984 · DOI 10.3390/children9071000
3. A Brief Mindfulness Intervention for Parents and Children before Pediatric Venipuncture: A Randomized Controlled Trial.
   Moline RL, Constantin K, Chambers CT, Powell D, et al · · 2022 · cited 3× · PMID 36553313 · DOI 10.3390/children9121869
4. Parent and child self- and co-regulation during pediatric venipuncture: Exploring heart rate variability and the effects of a mindfulness intervention.
   Constantin KL, Moline RL, Pillai Riddell R, Spence JR, et al · · 2022 · cited 3× · PMID 35603416 · DOI 10.1002/dev.22277