Cognitive TherapyNCT02859051
MEDi Robot for Pain Management at Induction
A study testing Humanoid Robot MEDi in people with Cognitive Therapy, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this study is to determine if a preparation teaching intervention before IV insertion, taught by MEDi to children and their parents, will lead to lower levels of expected and experienced pain and fear and less distressing pain memories, as compared to children who receive standard care. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cognitive Therapy
- What is being tested?
- Humanoid Robot MEDi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jul 2016to 25 May 2018
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- presenting for general surgery under general anesthesia, and in the American Society of Anesthesiologists class 1 or 2
Who cannot join
- patient presenting for day surgery
- patient requires an intravenous placed in day surgery unit
- patient cognitively unable to self-report pain
- patient with a hearing or visual impairment or developmental disability that precludes self-reporting ability
- family or child that is unable to communicate in English
- previous allergic reaction to propofol or lidocaine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Preparation Intervention for the Management of Children's Pain and Fear During Induction: Help From a Robot Named MEDi
The purpose of this study is to determine if a preparation teaching intervention before IV insertion, taught by MEDi to children and their parents, will lead to lower levels of expected and experienced pain and fear and less distressing pain memories, as compared to children who receive standard care. In addition, it will be examined whether this preparation intervention will lead to greater parental self-efficacy, less anxiety, and less distressing pain memories as compared to controls.
Read the detailed description
The primary aim is to determine the impact of using a humanoid robot in comparison to standard care. This proposal describes the first study in the world to test such novel technology for preparation teaching intervention before IV insertion. This work builds on previous research conducted by the research team and represents a logical next step for this collaborative group. This project team includes established and emerging leaders in pain management research. This will ensure successful implementation and completion of the project. These methods of teaching preparation have the potential for widespread application to other medical procedures and clinical settings (eg. oncology dentistry) and lead to improved health outcomes for children by easing their suffering and improving the quality of their healthcare encounters.
1.2 Research Questions
Research Question 1.) Does preparation administered by a humanoid robot (MEDi) reduce expectancies and experience of pain and fear of IV insertion in children?
Hypothesis 1.) Children who receive preparation by MEDi will report expecting and experiencing lower levels of fear and pain at IV insertion as compared to youth receiving standard care.
Research Question 2.) Does preparation administered by MEDi lead to higher self-efficacy and lower anxiety in parents of children undergoing IV insertion?
Hypothesis 2.) Parents of children who receive preparation by MEDi will report higher levels of self-efficacy and lower anxiety at their children's IV insertion as compared to youth receiving standard care.
Research Question 3.) Do children who receive preparation administered by MEDi and their parents have more accurate and positively estimated memories of pain and fear as compared to youth receiving standard care and their parents?
Hypothesis 3.) Children who receive preparation administered by MEDi and their parents will report more accurate and positively estimated memories of pain and fear as compared to youth receiving standard care and their parents.
Research Question 4.) Do children who receive preparation administered by MEDi prior to IV insertion and their parents expect to experience less pain, fear, anxiety, and higher self-efficacy in pain coping at future needle procedures as compared to youth receiving standard care and their parents?
Hypothesis 4.) Children who receive preparation administered by MEDi prior to IV insertion and their parents will report expecting to experience lower pain, fear, and anxiety and higher self-efficacy in pain coping at future needle procedures as compared to youth receiving standard care and their parents.
2.1 Study Design \& Setting
This study is a single-centre prospective randomized, controlled, two-armed trial: (1) humanoid robot, MEDi, provides preparation for intravenous placement; and (2) standard care. Patients will be recruited from day surgery at the Alberta Children's Hospital Calgary, AB. This study will follow the high methodological standards for reporting RCTs according to the Consolidated Standards of Reporting Trials guidelines - extension for nonpharmacological treatments and this trial will be registered with clinicaltrials.gov.
2.2. Study Population
Legal guardians and/or patients with the ability to understand the study will be asked to provide written informed consent prior to participation. Day surgery patients, between the ages of 4-12 years old who are presenting for general surgery under general anesthesia, and in the American Society of Anesthesiologists class 1 or 2, will be included.
- Conditions
- Cognitive Therapy
- Being tested
- Humanoid Robot MEDi
- Keywords
- Cognitive Behavioral Support provided by Robot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humanoid Robot MEDiDevice
Humanoid robot programmed with cognitive-behavioral interventions such as role modeling, teaching coping strategies, positive reinforcement, parent encouragement
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | No intervention |
| robot | Experimental | Humanoid robot interacts with child, teaching breathing and coping strategies. Receives: Device: Humanoid Robot MEDi |
What is being measured
The primary outcome is the main question the study is designed to answer.
child's pain
Faces Pain Scale-Revised (FPS-R) (Hicks, 2001)
Measured: at moment of child's IV start
Secondary outcomes (5)
child's fear
Children's Fear Scale (McMurtry, Noel, Chambers, \& McGrath, 2011)
Measured: at the moment of OR entry
parent self-efficacy
use 0-10 numerical rating scales to report the degree to which they feel self-efficacy in their ability to help their child manage their pain and fear
Measured: 30 mins to 3 hours before induction
parent anxiety
Parents will be asked to report on their own level of anxiety during the needle procedure using a 0-10 NRS ranging from 0 ('not at all nervous or anxious') to 10 ('most nervous or anxious').
Measured: 30 mins to 3 hours before induction
children's memory
, parents and children will be asked to provide their free recall of each of those periods using open-ended prompts
Measured: 2 weeks after child's induction
parents' memory
, parents and children will be asked to provide their free recall of each of those periods using open-ended prompts
Measured: 2 weeks after child's induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start8 Jul 2016
- Primary completion25 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive TherapyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Principal investigator, Tanya Beran, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859051
- Sponsor's protocol ID
- REB16-0148
- Status last verified
- Apr 2021
- First submitted
- 28 Jul 2016
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Preparation Intervention for the Management of Children's Pain and Fear During Induction: Help From a Robot Named MEDi
- ClinicalTrials.gov ID
- NCT02859051
- Acronym / sponsor ID
- REB16-0148
- Conditions
- Cognitive Therapy
- Keywords
- Cognitive Behavioral Support provided by Robot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 8 Jul 2016 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 8 Aug 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.
The purpose of this study is to determine if a preparation teaching intervention before IV insertion, taught by MEDi to children and their parents, will lead to lower levels of expected and experienced pain and fear and less distressing pain memories, as compared to children who receive standard care. In addition, it will be examined whether this preparation intervention will lead to greater parental self-efficacy, less anxiety, and less distressing pain memories as compared to controls.
Detailed description
The primary aim is to determine the impact of using a humanoid robot in comparison to standard care. This proposal describes the first study in the world to test such novel technology for preparation teaching intervention before IV insertion. This work builds on previous research conducted by the research team and represents a logical next step for this collaborative group. This project team includes established and emerging leaders in pain management research. This will ensure successful implementation and completion of the project. These methods of teaching preparation have the potential for widespread application to other medical procedures and clinical settings (eg. oncology dentistry) and lead to improved health outcomes for children by easing their suffering and improving the quality of their healthcare encounters.
1.2 Research Questions
Research Question 1.) Does preparation administered by a humanoid robot (MEDi) reduce expectancies and experience of pain and fear of IV insertion in children?
Hypothesis 1.) Children who receive preparation by MEDi will report expecting and experiencing lower levels of fear and pain at IV insertion as compared to youth receiving standard care.
Research Question 2.) Does preparation administered by MEDi lead to higher self-efficacy and lower anxiety in parents of children undergoing IV insertion?
Hypothesis 2.) Parents of children who receive preparation by MEDi will report higher levels of self-efficacy and lower anxiety at their children's IV insertion as compared to youth receiving standard care.
Research Question 3.) Do children who receive preparation administered by MEDi and their parents have more accurate and positively estimated memories of pain and fear as compared to youth receiving standard care and their parents?
Hypothesis 3.) Children who receive preparation administered by MEDi and their parents will report more accurate and positively estimated memories of pain and fear as compared to youth receiving standard care and their parents.
Research Question 4.) Do children who receive preparation administered by MEDi prior to IV insertion and their parents expect to experience less pain, fear, anxiety, and higher self-efficacy in pain coping at future needle procedures as compared to youth receiving standard care and their parents?
Hypothesis 4.) Children who receive preparation administered by MEDi prior to IV insertion and their parents will report expecting to experience lower pain, fear, and anxiety and higher self-efficacy in pain coping at future needle procedures as compared to youth receiving standard care and their parents.
2.1 Study Design \& Setting
This study is a single-centre prospective randomized, controlled, two-armed trial: (1) humanoid robot, MEDi, provides preparation for intravenous placement; and (2) standard care. Patients will be recruited from day surgery at the Alberta Children's Hospital Calgary, AB. This study will follow the high methodological standards for reporting RCTs according to the Consolidated Standards of Reporting Trials guidelines - extension for nonpharmacological treatments and this trial will be registered with clinicaltrials.gov.
2.2. Study Population
Legal guardians and/or patients with the ability to understand the study will be asked to provide written informed consent prior to participation. Day surgery patients, between the ages of 4-12 years old who are presenting for general surgery under general anesthesia, and in the American Society of Anesthesiologists class 1 or 2, will be included.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –No intervention |
| robot | Experimental | Device: Humanoid Robot MEDiHumanoid robot interacts with child, teaching breathing and coping strategies. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- presenting for general surgery under general anesthesia, and in the American Society of Anesthesiologists class 1 or 2
Key exclusion criteria (6 listed)
- patient presenting for day surgery
- patient requires an intravenous placed in day surgery unit
- patient cognitively unable to self-report pain
- patient with a hearing or visual impairment or developmental disability that precludes self-reporting ability
- family or child that is unable to communicate in English
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 |
|---|---|---|
| Humanoid Robot MEDiHumanoid robot programmed with cognitive-behavioral interventions such as role modeling, teaching coping strategies, positive reinforcement, parent encouragement | Device | robot |
Primary outcome
child's pain
Time frame: at moment of child's IV start
Faces Pain Scale-Revised (FPS-R) (Hicks, 2001)
5 secondary outcomes
child's fear
Time frame: at the moment of OR entry
parent self-efficacy
Time frame: 30 mins to 3 hours before induction
parent anxiety
Time frame: 30 mins to 3 hours before induction
children's memory
Time frame: 2 weeks after child's induction
parents' memory
Time frame: 2 weeks after child's induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humanoid Robot MEDi in people with Cognitive Therapy, run by University of Calgary 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 6 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: finished, as of the sponsor's last update on 27 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
child's pain (time frame: at moment of child's IV start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2021.