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Belly breathing with biofeedback app for Anxiety

N/A
Waitlist Available
Led By Theresa Newlove, Ph.D.
Research Sponsored by British Columbia Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to understand basic spoken and written English
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during entire blood collection procedure, beginning within ten seconds of sitting in the collection chair and ending within ten seconds of needle removal
Awards & highlights

Study 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: 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.

Eligible Conditions
  • Anxiety
  • Pain

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during entire blood collection procedure, beginning within ten seconds of sitting in the collection chair and ending within ten seconds of needle removal
This trial's timeline: 3 weeks for screening, Varies for treatment, and during entire blood collection procedure, beginning within ten seconds of sitting in the collection chair and ending within ten seconds of needle removal for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in self-reported expected pain
Change in self-reported preprocedural anxiety
Self-reported experienced pain
Secondary outcome measures
Belly breathing compliance
Belly breathing engagement
Self-reported experienced anxiety

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Belly breathing with biofeedback appExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention
Group III: Belly breathing without biofeedback appActive Control1 Intervention
Group IV: Belly breathing + visual distractionActive Control1 Intervention

Find a Location

Who is running the clinical trial?

British Columbia Children's HospitalLead Sponsor
26 Previous Clinical Trials
14,981 Total Patients Enrolled
1 Trials studying Anxiety
110 Patients Enrolled for Anxiety
Theresa Newlove, Ph.D.Principal InvestigatorBritish Columbia Children's Hospital

Frequently Asked Questions

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~34 spots leftby Apr 2025