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

Not Applicable

Completed

• Conditions: Pain; Needle Stick

• Registration Number: NCT03941717
• Lead Sponsor: University of Guelph

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.

Study Timeline

• Study First Submitted: 2019-05-05
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Study Start: 2019-10-04
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Proficiency in English

Exclusion Criteria

• Major developmental delays in child

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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").
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").

Secondary Outcome Measures

Name	Time	Method
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").
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").

Trial Locations

Locations (1)

University of Guelph; 🇨🇦 Guelph, Ontario, Canada