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

NCT02784301 | Unknown

• 1 other identifier: BBAppP2
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Pain; Anxiety

Outcome Measures

Primary Outcomes (3)

• Self-reported experienced pain

  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.

  Immediately following blood collection, on average within one minute of needle removal

• Change in self-reported preprocedural anxiety

  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.

  Prior to blood collection, on average within one minute of consent form completion and five minutes after initial VAS-A score is recorded

• Change in self-reported expected pain

  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.

  Prior to blood collection, on average within one minute of consent form completion and five minutes after initial CAS score is recorded

Secondary Outcomes (3)

• 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

• Self-reported experienced anxiety

  Following blood collection, on average within one minute of needle removal

Study Arms (4)

Belly breathing with biofeedback app

EXPERIMENTAL

Device: Belly breathing with biofeedback app

Standard of Care

NO INTERVENTION

Belly breathing without biofeedback app

ACTIVE COMPARATOR

Behavioral: Belly breathing without biofeedback app

Belly breathing + visual distraction

ACTIVE COMPARATOR

Behavioral: Belly breathing + visual distraction

Interventions

Belly breathing with biofeedback app DEVICE

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.

Belly breathing with biofeedback app

Belly breathing without biofeedback app BEHAVIORAL

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.

Belly breathing without biofeedback app

Belly breathing + visual distraction BEHAVIORAL

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.

Belly breathing + visual distraction

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Able to understand basic spoken and written English

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Children's Hospital: lead

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Related Publications (14)

• Bringuier S, Dadure C, Raux O, Dubois A, Picot MC, Capdevila X. The perioperative validity of the visual analog anxiety scale in children: a discriminant and useful instrument in routine clinical practice to optimize postoperative pain management. Anesth Analg. 2009 Sep;109(3):737-44. doi: 10.1213/ane.0b013e3181af00e4.

  PMID: 19690240 BACKGROUND

• Chiang LC, Ma WF, Huang JL, Tseng LF, Hsueh KC. Effect of relaxation-breathing training on anxiety and asthma signs/symptoms of children with moderate-to-severe asthma: a randomized controlled trial. Int J Nurs Stud. 2009 Aug;46(8):1061-70. doi: 10.1016/j.ijnurstu.2009.01.013. Epub 2009 Feb 26.

  PMID: 19246041 BACKGROUND

• Claar RL, Walker LS, Smith CA. The influence of appraisals in understanding children's experiences with medical procedures. J Pediatr Psychol. 2002 Oct-Nov;27(7):553-63. doi: 10.1093/jpepsy/27.7.553.

  PMID: 12228327 BACKGROUND

• Dehkordi P, Garde A, Karlen W, Wensley D, Ansermino JM, Dumont GA. Pulse rate variability compared with Heart Rate Variability in children with and without sleep disordered breathing. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:6563-6. doi: 10.1109/EMBC.2013.6611059.

  PMID: 24111246 BACKGROUND

• Elliott CH, Olson RA. The management of children's distress in response to painful medical treatment for burn injuries. Behav Res Ther. 1983;21(6):675-83. doi: 10.1016/0005-7967(83)90086-4. No abstract available.

  PMID: 6661152 BACKGROUND

• Huguet A, Stinson JN, McGrath PJ. Measurement of self-reported pain intensity in children and adolescents. J Psychosom Res. 2010 Apr;68(4):329-36. doi: 10.1016/j.jpsychores.2009.06.003. Epub 2009 Oct 2.

  PMID: 20307699 BACKGROUND

• Kemper KJ. Complementary and alternative medicine for children: does it work? West J Med. 2001 Apr;174(4):272-6. doi: 10.1136/ewjm.174.4.272. No abstract available.

  PMID: 11290687 BACKGROUND

• McDonnell L, Bowden ML. Breathing management: a simple stress and pain reduction strategy for use on a pediatric service. Issues Compr Pediatr Nurs. 1989;12(5):339-44. doi: 10.3109/01460868909038042.

  PMID: 2698873 BACKGROUND

• McGrath PA, Seifert CE, Speechley KN, Booth JC, Stitt L, Gibson MC. A new analogue scale for assessing children's pain: an initial validation study. Pain. 1996 Mar;64(3):435-443. doi: 10.1016/0304-3959(95)00171-9.

  PMID: 8783307 BACKGROUND

• Powers SW, Mitchell MJ, Byars KC, Bentti AL, LeCates SL, Hershey AD. A pilot study of one-session biofeedback training in pediatric headache. Neurology. 2001 Jan 9;56(1):133. doi: 10.1212/wnl.56.1.133. No abstract available.

  PMID: 11148256 BACKGROUND

• Shockey DP, Menzies V, Glick DF, Taylor AG, Boitnott A, Rovnyak V. Preprocedural distress in children with cancer: an intervention using biofeedback and relaxation. J Pediatr Oncol Nurs. 2013 May-Jun;30(3):129-38. doi: 10.1177/1043454213479035. Epub 2013 Mar 29.

  PMID: 23542082 BACKGROUND

• Tomlinson D, von Baeyer CL, Stinson JN, Sung L. A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics. 2010 Nov;126(5):e1168-98. doi: 10.1542/peds.2010-1609. Epub 2010 Oct 4.

  PMID: 20921070 BACKGROUND

• Tsze DS, von Baeyer CL, Bulloch B, Dayan PS. Validation of self-report pain scales in children. Pediatrics. 2013 Oct;132(4):e971-9. doi: 10.1542/peds.2013-1509. Epub 2013 Sep 2.

  PMID: 23999954 BACKGROUND

• Ward CM, Brinkman T, Slifer KJ, Paranjape SM. Using behavioral interventions to assist with routine procedures in children with cystic fibrosis. J Cyst Fibros. 2010 Mar;9(2):150-3. doi: 10.1016/j.jcf.2009.11.008. Epub 2009 Dec 30.

  PMID: 20044315 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Theresa Newlove, Ph.D.

  British Columbia Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theresa Newlove, Ph.D.

CONTACT

604-875-2345; tnewlove@cw.bc.ca

Evgenia Todorova, B.Sc., B.A.

CONTACT

604-417-3251; evgenia.todorova@cw.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Department of Psychology

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 27, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 27, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)