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Completed

NCT Number: NCT03941717

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

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.

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Key information

Conditions

Pain Agnosia Needle Stick Needlestick Injuries Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Wounds and Injuries Wounds, Penetrating Wounds, Stab

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Proficiency in English

Exclusion criteria

  • Major developmental delays in child

Treatment and study plan

Mindfulness-Based Condition

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

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.

Primary outcomes

  1. Child pain during the needle: Numeric Rating Scale (NRS)

    Time frame: 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").

  2. Child fear during the needle

    Time frame: 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 outcomes

  1. Child perceptions of parent distress

    Time frame: 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").

  2. Parent distress

    Time frame: 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 outcomes

  1. Parent perceptions of child pain

    Time frame: 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").

  2. Parent perceptions of child fear

    Time frame: 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").

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Collaborators

  • Social Sciences and Humanities Research Council of Canada

Registry information

Official study title

A Randomized Controlled Trial Testing the Effectiveness of a Mindfulness-Based Intervention for Both Parents and Children During Child Venipuncture

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 8, 2019
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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