Testing the Effectiveness of a Parent and Child Mindfulness-Based Intervention for Child Venipuncture
Condition: Pain; Needle Stick
MeSH terms: Needlestick Injuries
Study type: Interventional

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.
    

Intervention name(s): Mindfulness-Based Condition; Unfocused attention Condition
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
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)
Primary purpose: Other
Keywords: pain management; children; parents; mindfulness