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

NCT ID: NCT03941717

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-04
• Study Completion Date: 2020-03-13

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.

Conditions

Pain; Needle Stick

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness-Based Condition

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Unfocused attention Condition

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Proficiency in English

Exclusion Criteria

• Major developmental delays in child

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Social Sciences and Humanities Research Council of Canada

OTHER

Sponsor Role: collaborator

University of Guelph

OTHER

Sponsor Role: lead

Responsible Party

Meghan McMurtry

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

C. Meghan McMurtry, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guelph

Locations

University of Guelph

Guelph, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 29145288 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23503375 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22420118 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 18845193 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26085851 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23457685 (View on PubMed)

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

Reference Type: 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.

Reference Type: DERIVED

PMID: 35603416 (View on PubMed)

Other Identifiers

REB 5481

Identifier Type: -

Identifier Source: org_study_id