Clinical trial NCT03941717: Testing the Effectiveness of a Parent and Child Mindfulness-Based Intervention for Child Venipuncture
Official title: A Randomized Controlled Trial Testing the Effectiveness of a Mindfulness-Based Intervention for Both Parents and Children During Child Venipuncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Needle Stick
Keywords: pain management
children
parents
mindfulness
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: Social Sciences and Humanities Research Council of Canada
First posted: 2019-05-08
Enrollment: 61
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a single-site, two-arm, parallel group RCT with an intervention group (mindfulness-based intervention) and control group (unfocused-attention task, no active components).
Primary purpose: OTHER

Brief summary: 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.

Detailed description: To date, there are no randomized controlled trials (RCT) involving a mindfulness intervention for pediatric acute pain. Moreover, this will be the first study to investigate a parent mindfulness intervention in the context of child acute pain. Within a randomized control trial, the objectives of this study are to test the effectiveness of a mindfulness-based intervention for children undergoing a venipuncture 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. Participants will complete questionnaires immediately before and after child venipuncture. This study aims to offer a novel intervention that may improve both parent and child experience during a stressful situation in which parent and child unmanaged distress has deleterious effects. The long-term objectives of this line of research are to improve extant pain management interventions for children undergoing needle-pokes or other painful procedures.

Moderator Aims: To identify possible moderators of a differential treatment outcome (parent and child responses during the needle-poke). These psychological factors include parent and child state catastrophizing, trait experiential avoidance, and trait mindfulness which will be investigated as moderators of the impact of experimental group on the primary outcomes of child self-reported pain and fear, and secondary outcome of parent self-reported distress.

Eligibility criteria: Inclusion Criteria:

* Proficiency in English

Exclusion Criteria:

* Major developmental delays in child

Primary outcomes:
measure: Child pain during the needle: Numeric Rating Scale (NRS)
timeFrame: Within two minutes following the needle-poke.
measure: Child fear during the needle
timeFrame: Within two minutes following the needle-poke.
Secondary outcomes:
measure: Child perceptions of parent distress
timeFrame: Within five minutes following the needle-poke.
measure: Parent distress
timeFrame: Within five minutes following the needle-poke.
Other outcomes:
measure: Parent perceptions of child pain
timeFrame: Within five minutes following the needle-poke.
measure: Parent perceptions of child fear
timeFrame: Within five minutes following the needle-poke.
Locations:
city: Guelph
country: Canada
facility: University of Guelph
state: Ontario
Study officials:
affiliation: University of Guelph
name: C. Meghan McMurtry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Garland EL, Hanley A, Farb NA, Froeliger BE. State Mindfulness During Meditation Predicts Enhanced Cognitive Reappraisal. Mindfulness (N Y). 2015 Apr 1;6(2):234-242. doi: 10.1007/s12671-013-0250-6.
citation: Petter M, Chambers CT, MacLaren Chorney J. The effects of mindfulness-based attention on cold pressor pain in children. Pain Res Manag. 2013 Jan-Feb;18(1):39-45. doi: 10.1155/2013/857045.
citation: Siegel, D. J., & Bryson, T. P. (2011). The whole-brain child : 12 revolutionary strategies to nurture your child's developing mind. Delacorte Press. Retrieved from https://books.google.ca/books/about/The_Whole_Brain_Child.html?id=APzgCL8mgHUC&printsec=frontcover&source=kp_read_button&redir_esc=y#v=onepage&q&f=false
citation: Constantin KL, Moline RL, Pillai Riddell R, Spence JR, Fiacconi CM, Lupo-Flewelling K, McMurtry CM. Parent and child self- and co-regulation during pediatric venipuncture: Exploring heart rate variability and the effects of a mindfulness intervention. Dev Psychobiol. 2022 Jul;64(5):e22277. doi: 10.1002/dev.22277.