Evaluation of a Biofeedback Tool to Minimize Procedural Pain and Anxiety in Children
NCT ID: NCT02784301
Last Updated: 2016-05-27
Study Results
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Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2016-05-31
2016-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Belly breathing with biofeedback app
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.
Standard of Care
No interventions assigned to this group
Belly breathing without biofeedback app
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.
Belly breathing + visual distraction
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
5 Years
17 Years
ALL
Yes
Sponsors
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British Columbia Children's Hospital
OTHER
Responsible Party
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Theresa Newlove
Head, Department of Psychology
Principal Investigators
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Theresa Newlove, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
British Columbia Children's Hospital
Locations
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British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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BBAppP2
Identifier Type: -
Identifier Source: org_study_id
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