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

University of Guelph

Status: Completed

Conditions: Needle Stick; Pain

Treatments: Other: Unfocused attention Condition; Other: Mindfulness-Based Condition

Study type: Interventional

Funder types: Other

Identifiers

NCT03941717

REB 5481

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Proficiency in English

Exclusion criteria

• Major developmental delays in child

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Mindfulness-Based Condition

Experimental group

Description:

Parents and children in the mindfulness intervention condition will be provided with a tablet and accompanying headphones, and will listen to pre-recorded audio of a mindfulness activity. There is a parent and child version of the mindfulness intervention. Both scripts were developed by Siegel and Bryson (2011), and include a parent and child version of a mindfulness activity targeting worries and anxiety. Adjustments to the child script were informed by the work of Petter and colleagues (2013). Adjustments to the parent script were informed by the work of Garland and colleagues (2015). This activity will last 5-minutes.

Treatment:

Other: Mindfulness-Based Condition

Unfocused attention Condition

Sham Comparator group

Description:

Parents and children in the unfocused attention condition will be provided with a tablet and accompanying headphones, and will listen to pre-recorded audio of an unfocused attention activity. There is a parent and child version of this activity. The parent version has been validated in other research with healthy adults as a control for a mindfulness intervention (Garland, Hanley, Farb, \& Froeliger, 2015). This script was condensed in time from the original reading. The child version of the activity was developed for the current study, and was adapted from a mind-wandering script used for children aged 7-12 in past research (Spann, 2016). It was also informed by the unfocused attention script used for parents (Garland, Hanley, Farb, \& Froeliger, 2015), and work by Cahn and Polich (2009). This activity will last 5-mintues.

Treatment:

Other: Unfocused attention Condition