Evaluation of a Biofeedback Tool to Minimize Procedural Pain and Anxiety in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in self-reported preprocedural anxiety
研究概览
简要总结
Belly breathing is a popular relaxation technique used to reduce anxiety and pain in children during medical procedures. The investigators have developed a biofeedback game that will help teach children how to belly breathe in an interactive way. Existing studies have shown that biofeedback tools are effective ways to teach relaxation techniques to children. The purpose of this study is to evaluate 1) whether this new biofeedback tool is a more a effective and engaging way to teach belly breathing to children and 2) whether the application is more effective in reducing procedural pain and anxiety compared to standard of care, self-directed belly breathing alone or self-directed belly-breathing combined with visual distraction. The investigators hypothesize that:
-
The smartphone-based biofeedback game for belly breathing will reduce self-reported procedural anxiety and pain in children during a blood collection procedure compared to:
-
standard of care
-
belly breathing + standard care procedures
-
belly breathing with visual components of the application with no coaching or biofeedback distraction.
-
The smartphone-based biofeedback game will increase compliance with belly breathing compared to self-directed breathing.
-
Belly breathing with smartphone-based biofeedback game will be more engaging compared to self-directed belly breathing.
详细描述
- Purpose
The purpose of the present study is to evaluate the clinical efficacy of belly breathing using a smartphone-based biofeedback application to reduce procedural anxiety and pain in children having their blood drawn in the blood collection lab at BC Children's Hospital. This phase of the study will focus on evaluating 1) the efficacy of the application in children ages 5-17 for reducing self--reported pain and anxiety during blood collection and 2) the ability of the application to increase belly breathing compliance and engagement compared to traditional teaching methods. 2. Objectives
The proposed project aims to answer the following questions:
- Will the smartphone-based biofeedback game for belly breathing reduce self-reported procedural anxiety and pain in children during a blood collection procedure compared to a) standard of care b) belly breathing + standard care procedures or c) belly breathing with visual components of the application with no coaching or biofeedback distraction?
- Will the smartphone-based biofeedback game increase compliance with belly breathing compared to self-directed belly breathing?
- Will belly breathing with the smartphone-based biofeedback game be more engaging compared to self-directed belly breathing?
- Justification
Belly breathing, a type of deep diaphragmatic breathing that typically produces a relaxed state, is a popular behavioural intervention used to reduce anxiety in children undergoing medical procedures. Studies have shown that decreased anxiety is not only associated with decreased distress but also with decreased pain and less negative attitudes towards future medical procedures. Biofeedback is a tool that is used to teach children about the connection between mind and body. Very little research currently exists on using biofeedback applications to teach relaxation to children in a clinical setting; however, some evidence suggests that it could be effective. This study will examine the efficacy of using such a tool to teach belly breathing to children in order to reduce procedural anxiety and pain. 4. Research Methods
To explore the above hypotheses, the study design will employ a randomized control trial design. Expected and experienced self-report anxiety and pain scores in children assigned to the belly breathing biofeedback group will be compared to control group scores. The experimental group will be taught to belly breathe using the biofeedback game application and will be instructed to use it during the blood collection procedure. Control Group 1 will receive standard of care. Control Group 2 will receive belly breathing training without the application and be instructed to continue with self-directed belly breathing during the procedure. Control Group 3 will be taught belly breathing without the application plus receive distraction of watching the cartoon avatar in the hot air balloon rising through space; however, the avatar will not 'coach' the child as the visual cues for breathing (words and bubbles) will not be present and the avatar will not rise in response to correct belly breathing. Belly breathing compliance will be measured using extracted respiratory rates from collected PPG data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand basic spoken and written English
排除标准
- •No participants will be excluded from the study. However, data may be excluded during post-study analysis if a child:
- •suffers from a severe cardiovascular or respiratory condition that could significantly affect heart rate or respiratory rate
- •is taking medication that could significantly affect heart rate or respiratory rate
- •is using a local anesthetic during the blood collection procedure
结局指标
主要结局
Change in self-reported preprocedural anxiety
时间窗: Prior to blood collection, on average within one minute of consent form completion and five minutes after initial VAS-A score is recorded
Preprocedural state anxiety will be assessed using the Visual Analogue Scale of Anxiety (VAS-A), which consists of a 100 mm horizontal line with two end points labelled "no anxiety or fear" and "worst possible anxiety or fear." Anxiety will be measured at two time points, prior to and following intervention. The scale will be scored from 1 to 100 (1mm=1/100) and will be presented in a way that the child cannot see his/her previous ratings.
Self-reported experienced pain
时间窗: Immediately following blood collection, on average within one minute of needle removal
Pain will be assessed using the Color Analog Scale (CAS), which is a tool that contains a gradation of colour and width on a piece of plastic, ranging from white and narrow ('no pain') to wide and red ('the most pain') to represent different levels of pain intensity. The child will be instructed to slide a marker along the scale to indicate the colour and width that represents her/his pain and an evaluator then reads and records the corresponding numeral value scored from 0 to 10 in increments of 0.25 on the reverse side of the scale. The slider is originally positioned in the middle of scale. The CAS has been shown to be appropriate for children ages 5 to 18.
Change in self-reported expected pain
时间窗: Prior to blood collection, on average within one minute of consent form completion and five minutes after initial CAS score is recorded
Pain will be assessed twice prior to blood collection using the CAS: once before the intervention and once after the intervention or approximately five minutes after the first assessment for the non-intervention standard of care group.
次要结局
- Self-reported experienced anxiety(Following blood collection, on average within one minute of needle removal)
- Belly breathing compliance(During entire blood collection procedure, beginning within ten seconds of sitting in the collection chair and ending within ten seconds of needle removal)
- Belly breathing engagement(Immediately following blood collection; on average the questionnaire will be administered within one minute of needle removal)
研究者
Theresa Newlove
Head, Department of Psychology
British Columbia Children's Hospital