ConsentNCT03677219
Lumbar Puncture Video Study
A study testing Educational Video in people with Consent, run by University of British Columbia.
Trial summary
The purpose of this study is to improve the lumbar puncture (LP) consent process for pediatric patients. Though a commonly performed and safe procedure, LP can be anxiety-provoking for parents. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Consent
- What is being tested?
- Educational Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 May 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- parent of a patient less than 17 years of age
- parent present for consent
- patient under the care of the neurology team (directly or consulting)
- consenting physician able to communicate with parent directly or through a translator
Who cannot join
- patients with emergent indications for lumbar puncture, such as bacterial meningitis
- parent's unable to communicate in English and no translator was available
- consent not performed in person (over the phone)
About this study
Official title: An Educational Video to Address Parental Concern in Lumbar Puncture Consent: A Randomized Control Trial
The purpose of this study is to improve the lumbar puncture (LP) consent process for pediatric patients. Though a commonly performed and safe procedure, LP can be anxiety-provoking for parents. By using an educational video on a handheld device at the time of consent, we hope to improve parent understanding and comfort with the procedure.
Read the detailed description
Introduction: Lumbar puncture is a safe procedure commonly performed on pediatric patients for a variety of indications. Parents are informed of and consented to this procedure, but are often left with concerns and doubts. There are no published studies of the nature of the concerns of parents in North America, and no studies examining a process to improve pediatric lumbar puncture consent. Here the investigators conduct a randomized control study of a short educational video on a handheld device as an adjunct to the formal consent process.
Methods: 72 patients were enrolled, evenly divided between the control arm and video arm of the study. A survey was provided examining four key indices: parent self-rated understanding of the procedure, their perception of its safety, their perception of the painfulness and their overall comfort with their child undergoing LP. In addition, demographic characteristics such as prior experience with LP or epidural, language spoken at home, age of the child and indication for lumbar puncture, as well as qualitative information about parent concerns were collected.
- Conditions
- Consent
- Being tested
- Educational Video
- Keywords
- consent, lumbar puncture, pediatric, video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational VideoOther
The educational video is a 2 minute video depicting a live lumbar puncture on an infant interwoven with animations of the relevant anatomy.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Parents in this arm receive the standard lumbar puncture consent discussion and answer a survey about their concerns, and do not view an educational video. |
| Video | Experimental | Parents in this arm receive the standard lumbar puncture consent discussion and answer a survey about their concerns, then view a 2 minute educational video and respond to a second survey. Receives: Other: Educational Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likert Scale for Parent Understanding, Pain perception, Safety Perception and Comfort
4 separate Likert scales from 1-10 (1 is low, 10 is high) for each of understanding of procedure, pain perception, safety perception and comfort with procedure, each individual scale will be reported. For understanding, safety and comfort, a higher score represents better outcome, for pain perception a lower score represents better outcome.
Measured: within 10 minutes of consent discussion (controls) or viewing the video (video group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start1 Jan 2015
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConsentStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Model description
- Parents are randomized to either view an educational video or not
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ash Singhal, University of British Columbia
- Investigators
- Ashutosh Singhal, MD MSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677219
- Sponsor's protocol ID
- H14-00981
- Status last verified
- Sep 2018
- First submitted
- 17 Jan 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- Individual data sharing
- No
Publications
Dunbar M, Paton G, Singhal A. An Educational Video Improves Consent in Pediatric Lumbar Puncture: A Randomized Control Trial. Pediatr Neurol. 2019 Nov;100:74-79. doi: 10.1016/j.pediatrneurol.2019.04.014. Epub 2019 May 13.
PubMed 31201072
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Educational Video to Address Parental Concern in Lumbar Puncture Consent: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03677219
- Acronym / sponsor ID
- H14-00981
- Conditions
- Consent
- Keywords
- consent, lumbar puncture, pediatric, video
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 19 Sep 2018 (actual)
- 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 improve the lumbar puncture (LP) consent process for pediatric patients. Though a commonly performed and safe procedure, LP can be anxiety-provoking for parents. By using an educational video on a handheld device at the time of consent, we hope to improve parent understanding and comfort with the procedure.
Detailed description
Introduction: Lumbar puncture is a safe procedure commonly performed on pediatric patients for a variety of indications. Parents are informed of and consented to this procedure, but are often left with concerns and doubts. There are no published studies of the nature of the concerns of parents in North America, and no studies examining a process to improve pediatric lumbar puncture consent. Here the investigators conduct a randomized control study of a short educational video on a handheld device as an adjunct to the formal consent process.
Methods: 72 patients were enrolled, evenly divided between the control arm and video arm of the study. A survey was provided examining four key indices: parent self-rated understanding of the procedure, their perception of its safety, their perception of the painfulness and their overall comfort with their child undergoing LP. In addition, demographic characteristics such as prior experience with LP or epidural, language spoken at home, age of the child and indication for lumbar puncture, as well as qualitative information about parent concerns were collected.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Parents are randomized to either view an educational video or not
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Parents in this arm receive the standard lumbar puncture consent discussion and answer a survey about their concerns, and do not view an educational video. |
| Video | Experimental | Other: Educational VideoParents in this arm receive the standard lumbar puncture consent discussion and answer a survey about their concerns, then view a 2 minute educational video and respond to a second survey. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- parent of a patient less than 17 years of age
- parent present for consent
- patient under the care of the neurology team (directly or consulting)
- consenting physician able to communicate with parent directly or through a translator
Key exclusion criteria (3 listed)
- patients with emergent indications for lumbar puncture, such as bacterial meningitis
- parent's unable to communicate in English and no translator was available
- consent not performed in person (over the phone)
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 |
|---|---|---|
| Educational VideoThe educational video is a 2 minute video depicting a live lumbar puncture on an infant interwoven with animations of the relevant anatomy. | Other | Video |
Primary outcome
Likert Scale for Parent Understanding, Pain perception, Safety Perception and Comfort
Time frame: within 10 minutes of consent discussion (controls) or viewing the video (video group)
4 separate Likert scales from 1-10 (1 is low, 10 is high) for each of understanding of procedure, pain perception, safety perception and comfort with procedure, each individual scale will be reported. For understanding, safety and comfort, a higher score represents better outcome, for pain perception a lower score represents better outcome.
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 19 Sep 2018.
- Derived from this study: PubMed 31201072Dunbar M, Paton G, Singhal A. An Educational Video Improves Consent in Pediatric Lumbar Puncture: A Randomized Control Trial. Pediatr Neurol. 2019 Nov;100:74-79. doi: 10.1016/j.pediatrneurol.2019.04.014. Epub 2019 May 13.
- 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.
Ashutosh Singhal, MD MSc principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video in people with Consent, run by University of British Columbia.
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 4 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 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Likert Scale for Parent Understanding, Pain perception, Safety Perception and Comfort (time frame: within 10 minutes of consent discussion (controls) or viewing the video (video group)). 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 NCT03677219, which also lists 1 linked publication.
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 19 Sep 2018; AzTrials last refreshed its copy on 30 Oct 2026.