PainNCT02784301
Evaluation of a Biofeedback Tool to Minimize Procedural Pain and Anxiety in Children
A study testing Belly breathing with biofeedback app, Belly breathing without biofeedback app and Belly breathing + visual distraction in people with Pain and Anxiety, run by British Columbia Children's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- What is being tested?
- Belly breathing with biofeedback app, Belly breathing without biofeedback app and Belly breathing + visual distraction
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Able to understand basic spoken and written English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Children's Hospital
Vancouver, British Columbia, V5Z 4H4
Theresa Newlove, Ph.D., 604-875-2345 ext. 5172, tnewlove@cw.bc.ca
Evgenia Todorova, B.Sc., B.A., 604-417-3251, evgenia.todorova@cw.bc.ca
About this study
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.
Read the detailed description
- 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.
- Objectives The proposed project aims to answer the following questions:
- 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?
- Will the smartphone-based biofeedback game increase compliance with belly breathing compared to self-directed belly breathing?
- Will belly breathing with the smartphone-based biofeedback game be more engaging compared to self-directed belly breathing?
- 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.
- 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.
- 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.
- Being tested
- Belly breathing with biofeedback app, Belly breathing without biofeedback app, Belly breathing + visual distraction
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belly breathing with biofeedback appDevice
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 appBehavioural
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 distractionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Belly breathing with biofeedback app | Experimental | Not described Receives: Device: Belly breathing with biofeedback app |
| Standard of Care | No intervention | Not described |
| Belly breathing without biofeedback app | Active comparator | Not described Receives: Behavioral: Belly breathing without biofeedback app |
| Belly breathing + visual distraction | Active comparator | Not described Receives: Behavioral: Belly breathing + visual distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
A pulse oximeter will be used to collect a photoplethysmography (PPG) signal, which measures belly breathing compliance through heart rate monitoring.
Measured: 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
A questionnaire with likert-type questions scored on a scale of 1 to 5 (1=strongly disagree; 5=strongly agree) was developed for this study to measure engagement with belly breathing with the application compared to belly breathing without the application.
Measured: Immediately following blood collection; on average the questionnaire will be administered within one minute of needle removal
Self-reported experienced anxiety
Procedural state anxiety will be assessed using the VAS-A. The child will be asked to rate the anxiety he/she experienced while he/she was having his/her blood drawn.
Measured: Following blood collection, on average within one minute of needle removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Newlove, British Columbia Children's Hospital
- Investigators
- Theresa Newlove, Ph.D., Principal investigator, British Columbia Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784301
- Sponsor's protocol ID
- BBAppP2
- Status last verified
- May 2016
- First submitted
- 17 May 2016
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19690240Chiang 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.
PubMed 19246041Claar 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.
PubMed 12228327Dehkordi 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.
PubMed 24111246Elliott 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.
PubMed 6661152Huguet 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.
PubMed 20307699Kemper 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.
PubMed 11290687McDonnell 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.
PubMed 2698873McGrath 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.
PubMed 8783307Powers 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.
PubMed 11148256Shockey 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.
PubMed 23542082Tomlinson 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.
PubMed 20921070Tsze 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.
PubMed 23999954Ward 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.
PubMed 20044315
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Biofeedback Tool to Minimize Procedural Pain and Anxiety in Children
- ClinicalTrials.gov ID
- NCT02784301
- Acronym / sponsor ID
- BBAppP2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- British Columbia Children's HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- Objectives The proposed project aims to answer the following questions:
- 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?
- Will the smartphone-based biofeedback game increase compliance with belly breathing compared to self-directed belly breathing?
- Will belly breathing with the smartphone-based biofeedback game be more engaging compared to self-directed belly breathing?
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Able to understand basic spoken and written English
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belly breathing with biofeedback appThis 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. | Device | Belly breathing with biofeedback app |
| Belly breathing without biofeedback appThis 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. | Behavioural | Belly breathing without biofeedback app |
| Belly breathing + visual distractionThis 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. | Behavioural | Belly breathing + visual distraction |
Primary outcome
Self-reported experienced pain
Time frame: Immediately following blood collection, on average within one minute of needle removal
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.
Change in self-reported preprocedural anxiety
Time frame: Prior to blood collection, on average within one minute of consent form completion and five minutes after initial VAS-A score is recorded
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.
Change in self-reported expected pain
Time frame: Prior to blood collection, on average within one minute of consent form completion and five minutes after initial CAS score is recorded
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.
3 secondary outcomes
Belly breathing compliance
Time frame: 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
Time frame: Immediately following blood collection; on average the questionnaire will be administered within one minute of needle removal
Self-reported experienced anxiety
Time frame: Following blood collection, on average within one minute of needle removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Background: PubMed 19690240Bringuier 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.
- Background: PubMed 19246041Chiang 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.
- Background: PubMed 12228327Claar 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.
- Background: PubMed 24111246Dehkordi 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.
- Background: PubMed 6661152Elliott 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.
- Background: PubMed 20307699Huguet 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.
- Background: PubMed 11290687Kemper 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.
- Background: PubMed 2698873McDonnell 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.
- Background: PubMed 8783307McGrath 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.
- Background: PubMed 11148256Powers 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.
- Background: PubMed 23542082Shockey 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.
- Background: PubMed 20921070Tomlinson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Newlove, Ph.D. principal investigator
British Columbia Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Belly breathing with biofeedback app, Belly breathing without biofeedback app and Belly breathing + visual distraction in people with Pain and Anxiety, run by British Columbia Children's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Theresa Newlove, Ph.D. (604-875-2345 ext. 5172, tnewlove@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported experienced pain (time frame: Immediately following blood collection, on average within one minute of needle removal). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02784301, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.