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

NCT03941717 | Completed

• 1 other identifier: REB 5481
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Needle Stick

Keywords

pain management; children; parents; mindfulness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Child perceptions of parent distress

  Within five minutes following the needle-poke.

• Parent distress

  Within five minutes following the needle-poke.

Other Outcomes (2)

• Parent perceptions of child pain

  Within five minutes following the needle-poke.

• Parent perceptions of child fear

  Within five minutes following the needle-poke.

Study Arms (2)

Mindfulness-Based Condition

EXPERIMENTAL

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

Unfocused attention Condition

SHAM COMPARATOR

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

Interventions

Mindfulness-Based Condition OTHER

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.

Mindfulness-Based Condition

Unfocused attention Condition OTHER

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.

Unfocused attention Condition

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Proficiency in English

You may not qualify if:

• Major developmental delays in child

Sponsors & Collaborators

• University of Guelph: lead
• Social Sciences and Humanities Research Council of Canada: collaborator

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

Related Publications (9)

• Hsieh LY, Chen YR, Lu MC. Efficacy of cold application on pain during chest tube removal: a randomized controlled trial: A CONSORT-compliant article. Medicine (Baltimore). 2017 Nov;96(46):e8642. doi: 10.1097/MD.0000000000008642.

  PMID: 29145288 BACKGROUND

• Page MG, Stinson J, Campbell F, Isaac L, Katz J. Identification of pain-related psychological risk factors for the development and maintenance of pediatric chronic postsurgical pain. J Pain Res. 2013;6:167-80. doi: 10.2147/JPR.S40846. Epub 2013 Mar 5.

  PMID: 23503375 BACKGROUND

• Vervoort T, Goubert L, Vandenbossche H, Van Aken S, Matthys D, Crombez G. Child's and parents' catastrophizing about pain is associated with procedural fear in children: a study in children with diabetes and their mothers. Psychol Rep. 2011 Dec;109(3):879-95. doi: 10.2466/07.15.16.21.PR0.109.6.879-895.

  PMID: 22420118 BACKGROUND

• 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

  BACKGROUND

• Cahn BR, Polich J. Meditation (Vipassana) and the P3a event-related brain potential. Int J Psychophysiol. 2009 Apr;72(1):51-60. doi: 10.1016/j.ijpsycho.2008.03.013. Epub 2008 Sep 23.

  PMID: 18845193 BACKGROUND

• 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.

  PMID: 26085851 BACKGROUND

• 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.

  PMID: 23457685 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 35603416 DERIVED

MeSH Terms

Conditions

Pain; Needlestick Injuries; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds, Stab; Wounds, Penetrating; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• C. Meghan McMurtry, PhD

  University of Guelph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 8, 2019
• Study Start: October 4, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)