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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial Testing the Effectiveness of a Mindfulness-Based Intervention for Both Parents and Children During Child Venipuncture

Conditions
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Pain, Needle Stick

Intervention / Treatment
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* Other: Mindfulness-Based Condition
* Other: Unfocused attention Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Proficiency in English Exclusion Criteria: Major developmental delays in child

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Condition<br>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. | Other: Mindfulness-Based Condition<br>* Each script for the mindfulness-based intervention was slightly modified to fit the context of a venipuncture, and begins with instructions to take deep breaths. Both scripts aim to cultivate present moment awareness of experiences, curiosity, nonjudgement, and acceptance of experiences as they unfold. In particular, the scripts ask that the participant visualize their worries and feelings as a cloud in the sky, and probes for curious thoughts about these experiences. The temporary nature of sensations is described, and the participant is asked to keep this openness and curiosity during the venipuncture.<br>|
| Sham Comparator: Unfocused attention Condition<br>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. | Other: Unfocused attention Condition<br>* Each script for the unfocused attention task instructs participants to allow their mind and thoughts to roam. The aim is to encourage the participant to continue thinking and mind wandering as they typically would.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child pain during the needle: Numeric Rating Scale (NRS) | Between group changes in child self-reported pain as rated on a Numeric Rating Scale (NRS). The NRS has been used to assess pain intensity in children aged 7 and older during acutely painful procedures (Hsieh et al., 2017; Pagé, Stinson, Campbell, Isaac, & Katz, 2013; Vervoort et al., 2011).The NRS is rated on an 11-point numerical rating scale, ranging from 0 (no pain) to 10 (a lot of pain). | Within two minutes following the needle-poke. | 
| Child fear during the needle | Between group changes in child self-reported fear as rated on a Numeric Rating Scale (NRS). The NRS has been used to assess child fear in children aged 7 and older during acutely painful procedures (Hsieh et al., 2017; Vervoort et al., 2011). The NRS is rated on an 11-point numerical rating scale, ranging from 0 (not scared) to 10 (very scared). | Within two minutes following the needle-poke. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child perceptions of parent distress | Between group changes in child perceptions of parent fear as rated on a NRS (researcher generated). Children will be asked to Tell us how upset you think your parent was during the needle. This item will be rated on an 11-point numerical rating scale, ranging from 0 (not at all) to 10 (extremely). | Within five minutes following the needle-poke. | 
| Parent distress | Between group changes in parent self-report distress as rated on a NRS. Parents will be asked to provide ratings indicating their level of distress experienced on a NRS (researcher generated). For the purpose of the current study, the NRS will ask parents to Tell us how distressed you were during the needle. The NRS is rated on an 11-point numerical rating scale, ranging from 0 (not at all) to 10 (extremely). | Within five minutes following the needle-poke. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain management, children, parents, mindfulness