A Randomized Controlled Trial Testing the Effectiveness of a Mindfulness-Based Intervention for Both Parents and Children During Child Venipuncture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Child fear during the needle
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Proficiency in English
排除标准
- •Major developmental delays in child
研究组 & 干预措施
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.
干预措施: Mindfulness-Based Condition (Other)
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.
干预措施: Unfocused attention Condition (Other)
结局指标
主要结局
Child fear during the needle
时间窗: 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)
时间窗: 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").
次要结局
- Parent distress(Within five minutes following the needle-poke.)
- Child perceptions of parent distress(Within five minutes following the needle-poke.)
研究者
Meghan McMurtry
Associate Professor
University of Guelph