Clinical trial NCT02784301: Evaluation of a Biofeedback Tool to Minimize Procedural Pain and Anxiety in Children
Official title: Evaluation of a Biofeedback Tool to Minimize Procedural Pain and Anxiety in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Anxiety
Lead sponsor: British Columbia Children's Hospital
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 300
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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:

1. 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:

   1. standard of care
   2. belly breathing + standard care procedures
   3. belly breathing with visual components of the application with no coaching or biofeedback distraction.
2. The smartphone-based biofeedback game will increase compliance with belly breathing compared to self-directed breathing.
3. Belly breathing with smartphone-based biofeedback game will be more engaging compared to self-directed belly breathing.

Detailed description: 1. 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:
   1. 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?
   2. Will the smartphone-based biofeedback game increase compliance with belly breathing compared to self-directed belly breathing?
   3. Will belly breathing with the smartphone-based biofeedback game be more engaging compared to self-directed belly breathing?
3. 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.

   Two trained volunteers will recruit participants in the waiting room of the main blood collection in BC Children's Hospital. They will approach parents and children and invite them to participate in the study. If the parents and child are interested, they will be given consent and assent forms that they can read return to the volunteers at any time before the procedure should they decide to participate.
5. Data Analysis

Pain Scores: An analysis of covariance will be used to determine whether experimental subjects report significantly less pain during blood collection than the control patients. To determine whether belly breathing with the application will alter the expectation of pain, the sample will be divided into high and low expectations of pain using a median split on pain scores. A 2x3 repeated measures analysis of variance will be carried out comparing high and low expectations groups at Time 1, 2, and 3. Paired t-tests will be carried out on the high and low expectation groups within the experimental and control conditions to determine whether there will be any change in expected pain from Time 1 to Time 2.

In order for a clinically significant difference of 2 out 10 in pain score to be detected (alpha=0.05, power 80%) 70 children will be needed per group. In order to allow for non-compliance and post-study exclusions of children with cardiovascular/respiratory conditions or the use of topical anaesthetics, the investigators will need to recruit approximately 300 children.

Anxiety scores: Changes over time in the four groups will be analyzed by time x group interaction in a repeated analysis of variance. Paired T-Tests will be carried out on each of the four groups to determine whether there is any change in anxiety from Time 1 to Time 2.

A Pearson correlation will be used to investigate the relationship between anxiety scores and pain scores in each of the four groups.

Belly Breathing Compliance: Photoplethysmograph (PPG) data collected during blood collection from the experimental group and Control Groups 2 and 3 will be analyzed using a standard peak detection method. Independent Sample T-tests will be carried out on the amplitude of the RSA. Level of significance will be set at p=0.05.

Engagement Scores: The responses to each question on the Study Completion Questionnaires from the Experimental Group and Control Groups 2 and 3 will be analyzed separately using Independent Sample T-Test. Level of significance will be set at p=0.05. The Bonferroni Correction will be used to adjust for multiple measures.

Eligibility criteria: Inclusion Criteria:

* Able to understand basic spoken and written English

Exclusion Criteria:

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

Primary outcomes:
measure: Self-reported experienced pain
timeFrame: Immediately following blood collection, on average within one minute of needle removal
measure: Change in self-reported preprocedural anxiety
timeFrame: Prior to blood collection, on average within one minute of consent form completion and five minutes after initial VAS-A score is recorded
measure: Change in self-reported expected pain
timeFrame: Prior to blood collection, on average within one minute of consent form completion and five minutes after initial CAS score is recorded
Secondary outcomes:
measure: Belly breathing compliance
timeFrame: During entire blood collection procedure, beginning within ten seconds of sitting in the collection chair and ending within ten seconds of needle removal
measure: Belly breathing engagement
timeFrame: Immediately following blood collection; on average the questionnaire will be administered within one minute of needle removal
measure: Self-reported experienced anxiety
timeFrame: Following blood collection, on average within one minute of needle removal
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
Study officials:
affiliation: British Columbia Children's Hospital
name: Theresa Newlove, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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