Testing the Effectiveness of a Parent and Child Mindfulness-Based Intervention for Child Venipuncture
Study Details
Study Description
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 |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| 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.
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| 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.
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Outcome Measures
Primary Outcome Measures
- Child pain during the needle: Numeric Rating Scale (NRS) [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").
- Child fear during the needle [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
- Child perceptions of parent distress [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").
- Parent distress [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
- Parent perceptions of child pain [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").
- Parent perceptions of child fear [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").
Eligibility Criteria
Criteria
Inclusion Criteria:
- Proficiency in English
Exclusion Criteria:
- Major developmental delays in child
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Guelph | Guelph | Ontario | Canada | N1G 2W1 |
Sponsors and Collaborators
- University of Guelph
- Social Sciences and Humanities Research Council of Canada
Investigators
- Principal Investigator: C. Meghan McMurtry, PhD, University of Guelph
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- Pagé 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.
- 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.
- 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
- 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
- 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.
- REB 5481