Evaluation of a Biofeedback Tool to Minimize Procedural Pain and Anxiety in Children

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.

Conditions

• Pain
• Anxiety

Interventions

DEVICE

Belly breathing with biofeedback app

This intervention consists of learning how to belly breathe using a smartphone biofeedback application that coaches children how to breathe slowly and deeply. The app consists of a cartoon avatar in a hot air balloon that inhales and exhales bubbles. The goal of the biofeedback game is to a) teach a voluntary deep breathing protocol, b) detect compliance to the breathing protocol using the attached audio-based pulse oximeter sensor and c) to raise the hot air balloon in accordance to this compliance in order to motivate the children. Scenery changes as the balloon rises, driven by biofeedback, until it eventually reaches outer space.

BEHAVIORAL

Belly breathing without biofeedback app

This intervention consists of learning how to belly breathe without the biofeedback application prior to the blood collection and continuing with self-directed belly breathing during the procedure itself.

BEHAVIORAL

Belly breathing + visual distraction

This intervention consists of learning how to belly breathe without the application plus receiving visual distraction by watching a cartoon avatar in the hot air balloon rising through space. The avatar will not coach the child to breathe 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. Participants will be instructed to continue with self-directed breathing while also watching the visual distraction during the blood collection procedure.

Sponsors & Collaborators

• British Columbia Children's Hospital

  lead OTHER

Principal Investigators

• Theresa Newlove, Ph.D. · British Columbia Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2016-12-31

Completion

2016-12-31

Countries

• Canada

Study Locations