Needle Stick, Pain
Conditions
Keywords
pain management, children, parents, mindfulness
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.
Interventions
OTHERMindfulness-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.
OTHERUnfocused 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.
Sponsors
Social Sciences and Humanities Research Council of Canada
University of Guelph
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
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.
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).
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Proficiency in English
Exclusion criteria
* Major developmental delays in child
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Canada
Outcome results
None listed