Acute PainNCT01826383
Improving Parental Soothing by Video
A study testing Active-Video in people with Acute Pain, run by York University at 2 sites in Canada.
Trial summary
This study sets out to compare the effectiveness of a parent pain management coaching video that is 5-minutes in length. The investigators will be comparing an active-video to a placebo-video of equal length (and identical formatting). Participants will be 6 or 18 month infants undergoing routine immunization. Read more about this study
- Who is it for?
- Ages 5 to 20 monthsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- Active-Video
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2013to Jan 2014
- 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 20 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants must be 6 or 18 months old receiving a routine immunization injection.
- Parents must be fluent in English.
- Only one child per family can be enrolled.
Who cannot join
- No suspected developmental delays or chronic illnesses.
- Time spent in a Neonatal Intensive Care Unit.
- Born more than 3 weeks premature.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Dr. Saul Greenberg's Pediatric Clinic
Toronto, Ontario, M4P 3H1
Dr. Hartley Garfield's Pediatric Clinic
Toronto, Ontario, M5G 1N8
About this study
Official title: Improving Parental Soothing by Video: A Randomized Controlled Trial
This study sets out to compare the effectiveness of a parent pain management coaching video that is 5-minutes in length. The investigators will be comparing an active-video to a placebo-video of equal length (and identical formatting). Participants will be 6 or 18 month infants undergoing routine immunization. The investigators hypothesize the active video will result in a lowering of infant pain expressed post-immunization (3 minutes) and the increase in the parental use of distraction, physical comfort, and rocking.
Read the detailed description
Our goal is to determine if a video instructing parents on the principles of soothing their infant following immunization will influence soothing behaviours exhibited by parents, and pain reactivity and regulation in infants. We plan to present parents of young infants (6 months) and older infants (18 months) with either a Treatment Video instructing them on the ABCD's (Assess Anxiety, Belly Breathe, Calm Close Cuddle, Distraction; Copyright R. Pillai Riddell) of pain management or a Placebo Video with neutral information. There is very minimal risk because our suggestions are based on what parents deemed 'sensitive' (in our ongoing longitudinal study) were doing naturally i.e., without any intervention in their day-to-day lives. Additionally, in a separate study, that already received ethics approval, parents viewed these videos without any negative side effects.
Participants will be adult parents from one of two clinics in the Greater Toronto Area who bring their infant in for a routine immunization (12 or 18 months). In our cohort study (where we simply videotape dyads in the clinic).
Parents will be asked to complete a brief questionnaire (Parent Information Sheet) entailing basic demographic information and preimmunization ratings of their worry about their infant's pain from the immunization. The parents will also be asked to complete the 18-item Brief Symptom Inventory (BSI-18) and the Negative Affect subscale (IBQ-R Very short form), in addition to demographic information. The parents will subsquently be asked to view a brief video (Treatment or Placebo Video) discussing the ABCD's of pain management described above. During the infant's routine immunization procedure the parents and infant will be videotaped for approximately 10 minutes, and the parent will be asked a few brief questions post immunization including ratings of their infant's pain from the immunization procedure and the helpfulness of the video.
- Conditions
- Acute Pain
- Being tested
- Active-Video, Placebo Video
- Keywords
- Infant, Immunization
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active-VideoBehavioural
This group will watch an active-video with pain management strategies for parents
Placebo VideoBehavioural
This group will watch a placebo-video describing immunization generally.
| Study group | Role | What they receive |
|---|---|---|
| Active Video | Experimental | This is a five-minute video that coaches parents about how to soothe their infant post-immunization. Receives: Behavioral: Active-Video |
| Placebo Video | Placebo comparator | This is a video identical to that of the active video, except no specific instructions regarding how to soothe an infant post-immunization are given. Receives: Behavioral: Placebo Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Behaviour Pain Scale
Infant pain regulation was operationalized using The Modified Behaviour Pain Scale (MBPS), modified by Taddio et al. (1995) for use with infants during office procedures. The measure rates the severity of distress reflected in three types of infant pain behaviours: (1) facial expressions; (2) cry; and (3) body movements during 15-second epochs post-immunization (for 3 minutes). Infants are assigned a score from 0 to 3 (or 0 to 4 on the cry scale), with larger values indicating a more intense behavioural response (Total Range 0-10)
Measured: 3 minutes post-last needle
Secondary outcomes (1)
Measure of Adult and Infant Soothing and Distress
The MAISD (Measure of Adult and Infant Soothing and Distress; Cohen et al., 2005) is a behavior observation scale that was developed to examine the discrete behaviors exhibited by parents during children's invasive medical procedures. Rather than attempting to examine all behaviors, only those that were viewed as being potentially impacted by the treatment video will be included. Thus, distraction, rocking, physical comfort were selected. Each behaviour is coded every 5 seconds for either presence or absence (0 or 1). Three separate scores will be derived for each behaviour (distraction, rocking, physical comfort).
Measured: 3 minutes post-last needle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RRiddell, York University
- Investigators
- Rebecca R Pillai Riddell, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826383
- Sponsor's protocol ID
- York HPRC 2013-004
- Status last verified
- Apr 2015
- First submitted
- 3 Apr 2013
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Taddio A, Nulman I, Koren BS, Stevens B, Koren G. A revised measure of acute pain in infants. J Pain Symptom Manage. 1995 Aug;10(6):456-63. doi: 10.1016/0885-3924(95)00058-7.
PubMed 7561228Cohen, L.L., Bernard, R., McClellan, C., MacLaren, J. (2005). Assessing Medical Room Behaviour During Infants' Painful Procedures: The Measure of Adult and Infant Soothing and Distress (MAISD). Children's Health Care., 34, p. 81-94.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Parental Soothing by Video: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01826383
- Acronym / sponsor ID
- York HPRC 2013-004
- Conditions
- Acute Pain
- Keywords
- Infant, Immunization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Apr 2013 (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.
This study sets out to compare the effectiveness of a parent pain management coaching video that is 5-minutes in length. The investigators will be comparing an active-video to a placebo-video of equal length (and identical formatting). Participants will be 6 or 18 month infants undergoing routine immunization. The investigators hypothesize the active video will result in a lowering of infant pain expressed post-immunization (3 minutes) and the increase in the parental use of distraction, physical comfort, and rocking.
Detailed description
Our goal is to determine if a video instructing parents on the principles of soothing their infant following immunization will influence soothing behaviours exhibited by parents, and pain reactivity and regulation in infants. We plan to present parents of young infants (6 months) and older infants (18 months) with either a Treatment Video instructing them on the ABCD's (Assess Anxiety, Belly Breathe, Calm Close Cuddle, Distraction; Copyright R. Pillai Riddell) of pain management or a Placebo Video with neutral information. There is very minimal risk because our suggestions are based on what parents deemed 'sensitive' (in our ongoing longitudinal study) were doing naturally i.e., without any intervention in their day-to-day lives. Additionally, in a separate study, that already received ethics approval, parents viewed these videos without any negative side effects.
Participants will be adult parents from one of two clinics in the Greater Toronto Area who bring their infant in for a routine immunization (12 or 18 months). In our cohort study (where we simply videotape dyads in the clinic).
Parents will be asked to complete a brief questionnaire (Parent Information Sheet) entailing basic demographic information and preimmunization ratings of their worry about their infant's pain from the immunization. The parents will also be asked to complete the 18-item Brief Symptom Inventory (BSI-18) and the Negative Affect subscale (IBQ-R Very short form), in addition to demographic information. The parents will subsquently be asked to view a brief video (Treatment or Placebo Video) discussing the ABCD's of pain management described above. During the infant's routine immunization procedure the parents and infant will be videotaped for approximately 10 minutes, and the parent will be asked a few brief questions post immunization including ratings of their infant's pain from the immunization procedure and the helpfulness of the video.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Video | Experimental | Behavioral: Active-VideoThis is a five-minute video that coaches parents about how to soothe their infant post-immunization. |
| Placebo Video | Placebo comparator | Behavioral: Placebo VideoThis is a video identical to that of the active video, except no specific instructions regarding how to soothe an infant post-immunization are given. |
Who may qualify
- Ages
- 5 to 20 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants must be 6 or 18 months old receiving a routine immunization injection.
- Parents must be fluent in English.
- Only one child per family can be enrolled.
Key exclusion criteria (3 listed)
- No suspected developmental delays or chronic illnesses.
- Time spent in a Neonatal Intensive Care Unit.
- Born more than 3 weeks premature.
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 |
|---|---|---|
| Active-VideoThis group will watch an active-video with pain management strategies for parents | Behavioural | Active Video |
| Placebo VideoThis group will watch a placebo-video describing immunization generally. | Behavioural | Placebo Video |
Primary outcome
Modified Behaviour Pain Scale
Time frame: 3 minutes post-last needle
Infant pain regulation was operationalized using The Modified Behaviour Pain Scale (MBPS), modified by Taddio et al. (1995) for use with infants during office procedures. The measure rates the severity of distress reflected in three types of infant pain behaviours: (1) facial expressions; (2) cry; and (3) body movements during 15-second epochs post-immunization (for 3 minutes). Infants are assigned a score from 0 to 3 (or 0 to 4 on the cry scale), with larger values indicating a more intense behavioural response (Total Range 0-10)
1 secondary outcome
Measure of Adult and Infant Soothing and Distress
Time frame: 3 minutes post-last needle
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 14 Apr 2015.
- Background: PubMed 7561228Taddio A, Nulman I, Koren BS, Stevens B, Koren G. A revised measure of acute pain in infants. J Pain Symptom Manage. 1995 Aug;10(6):456-63. doi: 10.1016/0885-3924(95)00058-7.
- BackgroundCohen, L.L., Bernard, R., McClellan, C., MacLaren, J. (2005). Assessing Medical Room Behaviour During Infants' Painful Procedures: The Measure of Adult and Infant Soothing and Distress (MAISD). Children's Health Care., 34, p. 81-94.
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
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.
Rebecca R Pillai Riddell, PhD principal investigator
York University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active-Video in people with Acute Pain, run by York University at 2 sites 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 3 inclusion and 3 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Modified Behaviour Pain Scale (time frame: 3 minutes post-last needle). 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 NCT01826383, which also lists 2 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 14 Apr 2015.