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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03941717
Recruitment Status : Suspended (COVID-19 restrictions)
First Posted : May 8, 2019
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Social Sciences and Humanities Research Council of Canada
Information provided by (Responsible Party):
Meghan McMurtry, University of Guelph

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.

Condition or disease Intervention/treatment Phase
Pain Needle Stick Other: Mindfulness-Based Condition Other: Unfocused attention Condition Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Single (Participant)
Masking Description: Participants will not be made explicitly aware of which group (intervention or control) that they have been allocated. Participants in each group will be provided with a tablet and guided through an audio activity. Further, participants will not be made aware of the kind of intervention being used, however, it is possible that participants may become aware of the nature of their treatment allocation in the mindfulness group.
Primary Purpose: Other
Official Title: A Randomized Controlled Trial Testing the Effectiveness of a Mindfulness-Based Intervention for Both Parents and Children During Child Venipuncture
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: Mindfulness-Based Condition
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
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.

Sham Comparator: Unfocused attention Condition
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
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.




Primary Outcome Measures :
  1. Child pain during the needle: Numeric Rating Scale (NRS) [ Time Frame: Within two minutes following the needle-poke. ]
    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").

  2. Child fear during the needle [ Time Frame: Within two minutes following the needle-poke. ]
    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").


Secondary Outcome Measures :
  1. Child perceptions of parent distress [ Time Frame: Within five minutes following the needle-poke. ]
    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").

  2. Parent distress [ Time Frame: Within five minutes following the needle-poke. ]
    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").


Other Outcome Measures:
  1. Parent perceptions of child pain [ Time Frame: Within five minutes following the needle-poke. ]
    Between group changes in parent report of child pain as rated on a NRS (Vervoort et al., 2011). Parents will be prompted to provide ratings corresponding to how much pain they think their child experienced. The NRS is rated on an 11-point numerical rating scale, ranging from 0 ("no pain") to 10 ("a lot of pain").

  2. Parent perceptions of child fear [ Time Frame: Within five minutes following the needle-poke. ]
    Between group changes in parent report of child fear as rated on a NRS (Vervoort et al., 2011). Parents will be prompted to provide ratings corresponding to how much pain they think their child experienced. The NRS is rated on an 11-point numerical rating scale, ranging from 0 ("not scared") to 10 ("very scared").



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Proficiency in English

Exclusion Criteria:

  • Major developmental delays in child

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941717


Locations
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Canada, Ontario
University of Guelph
Guelph, Ontario, Canada, N1G 2W1
Sponsors and Collaborators
University of Guelph
Social Sciences and Humanities Research Council of Canada
Investigators
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Principal Investigator: C. Meghan McMurtry, PhD University of Guelph
Publications:
Spann, C. A. (2016). Mindfulness and mind-wandering: the impact of brief interventions on child affect, arousal, and cognition. The University of Texas at Arlington. Retrieved from https://uta-ir.tdl.org/uta-ir/bitstream/handle/10106/25806/SPANN-DISSERTATION-2016.pdf?sequence=1&isAllowed=y
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

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Responsible Party: Meghan McMurtry, Associate Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT03941717    
Other Study ID Numbers: REB 5481
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meghan McMurtry, University of Guelph:
pain management
children
parents
mindfulness
Additional relevant MeSH terms:
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Needlestick Injuries
Wounds, Stab
Wounds, Penetrating
Wounds and Injuries