PainNCT02840942
Robots to Reduce Pain During IV Placement
A study testing Coping Robot and Non-coping Robot in people with Pain and Anxiety, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
Peripheral intravenous catheters (IVs) are utilized in the majority of hospitalized children. The placement of IVs requires significant staff time, contributes to health care costs, and causes pain and distress in the patients receiving them. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- What is being tested?
- Coping Robot and Non-coping Robot
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 20 Jul 2019
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Speaks English or Spanish
- Age limits
- would be getting IV and child life regardless of participation in study
Who cannot join
- severe developmental delay (parent assessment)
- afraid of robots
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: Socially Assistive Robots to Reduce Children's Pain During Peripheral IV Placement
Peripheral intravenous catheters (IVs) are utilized in the majority of hospitalized children. The placement of IVs requires significant staff time, contributes to health care costs, and causes pain and distress in the patients receiving them. Techniques currently used at Children's Hospital Los Angeles (CHLA) to reduce children's anxiety and increase success of IV placement center depends on members of the Child Life Department distracting patients during insertion. Recent literature has suggested that humanoid robots can be a powerful form of distraction and lead to decreased pain during painful procedures in children. Work done by the University of Southern California (USC) Interaction Lab has shown that socially assistive robots can use techniques more complex than pure distraction to lead to a human-robot interaction that is perceived as more positive by the human. The investigators propose a project pairing children receiving an IV with either a (1) Child Life staff member only (2) pure distraction robot + Child Life or (3) an robot teaching coping skills + Child Life with a goal of reduced pain. Pain will be measured by participant self-report, family member perceived pain, parasympathetic activation, and pain behaviors as measured by video.
Read the detailed description
At USC University Park, computer science collaborators have programmed the robot to speak the script which will be used for interaction with participants (see additional supporting documents).
At CHLA, patients arriving to the radiology suite for IV placement prior to MRI and utilizing Child Life Services will be approached and consented for inclusion. No participant will receive a IV purely for the purpose of the study; only participants already ordered to receive IV by the medical team will be included. After consent participants will be randomized in blocks using a random-condition generating document to one of three test conditions: (1) control, with the usual distraction services provided by one of the hospital's child life specialists (2) usual child life + non-coping robot or (2) usual child life + coping robot.
Prior to the procedure participant's parent (or legal guardian) will complete a short survey related to pain with previous IV insertions, anxiety related to procedures, and attitudes toward robots. Participant's parent/guardian will also complete a validated measure of child temperament. Participants will complete a baseline measure of their temperament. Participants will then rate current level of pain using the Wong-Baker FACES scale. Participant's anxiety level will be assessed using the Children's Fear Scale. Participant's baseline heart rate and blood pressure is recorded.
The IV placement itself will be video recorded for all conditions. Independent assessors not aware of the research aims will review the tape to score measures of the strength of robot-child interaction and pain behaviors. One research team member will record the number of attempts needed to place the IV. A trained research team member will be responsible for operating the robot if randomized to that condition.
The robot used is the MAKI - an open-source 3D printable robot designed by Hello Robo Inc. The company has not provided any funding to this project. During the interaction the robot will speak in a child-like, gender neutral voice. It will ask short questions of participants and have pre-recorded response options (see MAKI script in supporting documents). Participants will interact with either child life or the robot by touching tablets. This is a minimum risk study, similar to the risk involved in watching a video on a screen. The robot is small and only moves its facial features, participants are not touching it.
Pre- and post-intervention participants will repeat the FACES and Fear Scales. The participant and parent/guardian will then be given a short post-survey regarding thoughts on the utility of the interaction and the amount of the participant's pain. Heart rate will be monitored continuously throughout the interaction. Videos will be evaluated using the modified Yale Preoperative Anxiety Index and The Child-Adult Medical Procedure Interaction Scale-Short Form (CAMPIS-SF).
- Being tested
- Coping Robot, Non-coping Robot
- Keywords
- intravenous line, robot
- 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.
Coping RobotBehavioural
Socially assistive robot "MAKI" will interact with children via tablet game designed to teach coping skills.
Non-coping RobotBehavioural
Socially assistive robot "MAKI" will interact with children via tablet game designed to be distraction only.
| Study group | Role | What they receive |
|---|---|---|
| Non-robot | No intervention | Patients will interact with Child Life as per usual routine, no robot condition |
| Coping Robot | Experimental | Robot will play coping game with children. Robot will speak and child will respond by touching tablet. Child life still present. Receives: Behavioral: Coping Robot |
| Non-coping Robot | Experimental | Robot will play distraction only game, in addition to Child Life and routine cares Receives: Behavioral: Non-coping Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Scale Score from baseline to post-intervention
Using Wong-baker faces pain scale
Measured: through study completion, an average of 1 hour
Secondary outcomes (6)
IV placement attempts
record raw number of attempts to compare average between arms
Measured: through study completion, an average of 1 hour
Patient/Child satisfaction with robot interaction
by survey
Measured: Day 1
CAMPIS score
on video review
Measured: Day 1
mYPAS score
on video review
Measured: Day 1
Change in Anxiety Scale Score from baseline to post-intervention
using fear faces scale
Measured: through study completion, an average of 1 hour
heart rate
using pulse oximeter
Measured: through study completion, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start1 Sep 2016
- Primary completion20 Jul 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California
- Responsible party
- Principal investigator, Margaret Trost MD, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840942
- Sponsor's protocol ID
- CHLA-14-00231
- Status last verified
- Jan 2024
- First submitted
- 20 May 2016
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Okita SY. Self-other's perspective taking: the use of therapeutic robot companions as social agents for reducing pain and anxiety in pediatric patients. Cyberpsychol Behav Soc Netw. 2013 Jun;16(6):436-41. doi: 10.1089/cyber.2012.0513. Epub 2013 Mar 18.
PubMed 23505968Beran TN, Ramirez-Serrano A, Vanderkooi OG, Kuhn S. Reducing children's pain and distress towards flu vaccinations: a novel and effective application of humanoid robotics. Vaccine. 2013 Jun 7;31(25):2772-7. doi: 10.1016/j.vaccine.2013.03.056. Epub 2013 Apr 24.
PubMed 23623861Trost MJ, Chrysilla G, Gold JI, Mataric M. Socially-Assistive Robots Using Empathy to Reduce Pain and Distress during Peripheral IV Placement in Children. Pain Res Manag. 2020 Apr 9;2020:7935215. doi: 10.1155/2020/7935215. eCollection 2020.
PubMed 32351642
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socially Assistive Robots to Reduce Children's Pain During Peripheral IV Placement
- ClinicalTrials.gov ID
- NCT02840942
- Acronym / sponsor ID
- CHLA-14-00231
- Keywords
- intravenous line, robot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- University of Southern California
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 21 Jul 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.
Peripheral intravenous catheters (IVs) are utilized in the majority of hospitalized children. The placement of IVs requires significant staff time, contributes to health care costs, and causes pain and distress in the patients receiving them. Techniques currently used at Children's Hospital Los Angeles (CHLA) to reduce children's anxiety and increase success of IV placement center depends on members of the Child Life Department distracting patients during insertion. Recent literature has suggested that humanoid robots can be a powerful form of distraction and lead to decreased pain during painful procedures in children. Work done by the University of Southern California (USC) Interaction Lab has shown that socially assistive robots can use techniques more complex than pure distraction to lead to a human-robot interaction that is perceived as more positive by the human. The investigators propose a project pairing children receiving an IV with either a (1) Child Life staff member only (2) pure distraction robot + Child Life or (3) an robot teaching coping skills + Child Life with a goal of reduced pain. Pain will be measured by participant self-report, family member perceived pain, parasympathetic activation, and pain behaviors as measured by video.
Detailed description
At USC University Park, computer science collaborators have programmed the robot to speak the script which will be used for interaction with participants (see additional supporting documents).
At CHLA, patients arriving to the radiology suite for IV placement prior to MRI and utilizing Child Life Services will be approached and consented for inclusion. No participant will receive a IV purely for the purpose of the study; only participants already ordered to receive IV by the medical team will be included. After consent participants will be randomized in blocks using a random-condition generating document to one of three test conditions: (1) control, with the usual distraction services provided by one of the hospital's child life specialists (2) usual child life + non-coping robot or (2) usual child life + coping robot.
Prior to the procedure participant's parent (or legal guardian) will complete a short survey related to pain with previous IV insertions, anxiety related to procedures, and attitudes toward robots. Participant's parent/guardian will also complete a validated measure of child temperament. Participants will complete a baseline measure of their temperament. Participants will then rate current level of pain using the Wong-Baker FACES scale. Participant's anxiety level will be assessed using the Children's Fear Scale. Participant's baseline heart rate and blood pressure is recorded.
The IV placement itself will be video recorded for all conditions. Independent assessors not aware of the research aims will review the tape to score measures of the strength of robot-child interaction and pain behaviors. One research team member will record the number of attempts needed to place the IV. A trained research team member will be responsible for operating the robot if randomized to that condition.
The robot used is the MAKI - an open-source 3D printable robot designed by Hello Robo Inc. The company has not provided any funding to this project. During the interaction the robot will speak in a child-like, gender neutral voice. It will ask short questions of participants and have pre-recorded response options (see MAKI script in supporting documents). Participants will interact with either child life or the robot by touching tablets. This is a minimum risk study, similar to the risk involved in watching a video on a screen. The robot is small and only moves its facial features, participants are not touching it.
Pre- and post-intervention participants will repeat the FACES and Fear Scales. The participant and parent/guardian will then be given a short post-survey regarding thoughts on the utility of the interaction and the amount of the participant's pain. Heart rate will be monitored continuously throughout the interaction. Videos will be evaluated using the modified Yale Preoperative Anxiety Index and The Child-Adult Medical Procedure Interaction Scale-Short Form (CAMPIS-SF).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-robot | No intervention | –Patients will interact with Child Life as per usual routine, no robot condition |
| Coping Robot | Experimental | Behavioral: Coping RobotRobot will play coping game with children. Robot will speak and child will respond by touching tablet. Child life still present. |
| Non-coping Robot | Experimental | Behavioral: Non-coping RobotRobot will play distraction only game, in addition to Child Life and routine cares |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Speaks English or Spanish
- Age limits
- would be getting IV and child life regardless of participation in study
Key exclusion criteria (2 listed)
- severe developmental delay (parent assessment)
- afraid of robots
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 |
|---|---|---|
| Coping RobotSocially assistive robot "MAKI" will interact with children via tablet game designed to teach coping skills. | Behavioural | Coping Robot |
| Non-coping RobotSocially assistive robot "MAKI" will interact with children via tablet game designed to be distraction only. | Behavioural | Non-coping Robot |
Primary outcome
Change in Pain Scale Score from baseline to post-intervention
Time frame: through study completion, an average of 1 hour
Using Wong-baker faces pain scale
6 secondary outcomes
IV placement attempts
Time frame: through study completion, an average of 1 hour
Patient/Child satisfaction with robot interaction
Time frame: Day 1
CAMPIS score
Time frame: Day 1
mYPAS score
Time frame: Day 1
Change in Anxiety Scale Score from baseline to post-intervention
Time frame: through study completion, an average of 1 hour
heart rate
Time frame: through study completion, an average of 1 hour
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 11 Jan 2024.
- Background: PubMed 23505968Okita SY. Self-other's perspective taking: the use of therapeutic robot companions as social agents for reducing pain and anxiety in pediatric patients. Cyberpsychol Behav Soc Netw. 2013 Jun;16(6):436-41. doi: 10.1089/cyber.2012.0513. Epub 2013 Mar 18.
- Background: PubMed 23623861Beran TN, Ramirez-Serrano A, Vanderkooi OG, Kuhn S. Reducing children's pain and distress towards flu vaccinations: a novel and effective application of humanoid robotics. Vaccine. 2013 Jun 7;31(25):2772-7. doi: 10.1016/j.vaccine.2013.03.056. Epub 2013 Apr 24.
- Derived from this study: PubMed 32351642Trost MJ, Chrysilla G, Gold JI, Mataric M. Socially-Assistive Robots Using Empathy to Reduce Pain and Distress during Peripheral IV Placement in Children. Pain Res Manag. 2020 Apr 9;2020:7935215. doi: 10.1155/2020/7935215. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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 Coping Robot and Non-coping Robot in people with Pain and Anxiety, run by Children's Hospital Los Angeles at 1 site in United States.
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 3 inclusion and 2 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 11 Jan 2024. 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 United States. 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?
Change in Pain Scale Score from baseline to post-intervention (time frame: through study completion, an average of 1 hour). 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 NCT02840942, which also lists 3 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 11 Jan 2024.