Hematological MalignanciesPHIPA-PEPLNCT02834156
Impact of Child Positioning on Pain During a Lumbar Puncture
A study testing LP in a seated position then LP in a lying position and LP in a lying position then LP in a seated position in people with Hematological Malignancies, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
This protocol is a pilot study on standard care. The main goal is to assess the impact of positioning on lumbar puncture process especially on pain sensitivity in children. It's a prospective, monocentric, randomized, open-label, cross-over study. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- LP in a seated position then LP in a lying position and LP in a lying position then LP in a seated position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2015to 23 Aug 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 2 and 18 years old
- Patients requiring at least 2 therapeutic lumbar punctures
- Patients able to receive analgesic procedure according to 20005 good practices recommendation
- Presence of one parent during LP procedure
- Child able to use assessment scales
- LP realized with a 20 G needle
Show all 9Show fewer
- Platelets > 50000
- Child with prior clinical examination
- Affiliated to a health care insurance regimen
Who cannot join
- Seated or lying position impossible
- Lumbar puncture contraindication
- Patient or parent opposition to second LP realization in the required position
- Clotting trouble on LP day not allowing the LP procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact Assessment of Positioning on Pain Sensitivity During a Lumbar Puncture in Children
This protocol is a pilot study on standard care. The main goal is to assess the impact of positioning on lumbar puncture process especially on pain sensitivity in children.
It's a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is one year, and number of inclusions forecasted is about 30. Each patient will have one LP in a seated position and one in a lying position.
Read the detailed description
In Pediatric Oncology Hematology, invasive procedures such lumbar punctures or myelograms are essential to diseases diagnosis and treatment.
In hematological malignancies, lumbar punctures are particularly frequent as the therapy processes. Despite a good analgesia, this repeated procedure can generate pain, anxiety, apprehension leading to an increasing difficulty in the procedure realization.
Two positions are possible to carry out lumbar puncture: seated or lying position.
The main goal of this study is to assess the impact of the child positioning during the lumbar puncture process in term of pain, anxiety and stress.
This study is a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is 1 year, 30 patients will be included from 2 to 18 years old.
Each patient will have 2 LP one in seated and one in lying position in a specific order determined by randomization.
All data regarding pain and anxiety will be collected the day of LP. Patients will be re contacted 48 hours and 15 days after LP procedure in order to evaluate complications such post-lumbar puncture syndrome or hematoma. The main analysis will be done on intent-to-treat-analysis basis and will compare pain intensity between the two groups.
- Conditions
- Hematological Malignancies
- Being tested
- LP in a seated position then LP in a lying position, LP in a lying position then LP in a seated position
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP in a seated position then LP in a lying positionOther
LP in a lying position then LP in a seated positionOther
| Study group | Role | What they receive |
|---|---|---|
| LP in a seated position then LP in a lying position | Other | Patients will have first a lumbar puncture (LP) in a seated position then a LP in a lying position Receives: Other: LP in a seated position then LP in a lying position |
| LP in a lying position then LP in a seated position | Other | Patients will have first a lumbar puncture (LP) in a lying position then a LP in a seated position Receives: Other: LP in a lying position then LP in a seated position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain sensitivity during the lumbar puncture procedure.
It will be evaluated throw specific pain assessment scales according to patient age
Measured: duration of the procedure
Secondary outcomes (2)
Anxiety during the lumbar puncture procedure on a scale of one to ten
Measured: duration of the procedure
Time of the lumbar puncture procedure
Measured: duration of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study start30 Jun 2015
- Primary completion23 Aug 2017
- Study completion23 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834156
- Sponsor's protocol ID
- 15-PP-05
- Acronym
- PHIPA-PEPL
- Status last verified
- Mar 2018
- First submitted
- 8 Jul 2016
- Last updated
- 12 Mar 2018
- 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 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Assessment of Positioning on Pain Sensitivity During a Lumbar Puncture in Children
- ClinicalTrials.gov ID
- NCT02834156
- Acronym / sponsor ID
- PHIPA-PEPL / 15-PP-05
- Conditions
- Hematological Malignancies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 23 Aug 2017 (actual)
- Study completion
- 23 Aug 2017 (actual)
- First posted
- 15 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.
This protocol is a pilot study on standard care. The main goal is to assess the impact of positioning on lumbar puncture process especially on pain sensitivity in children.
It's a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is one year, and number of inclusions forecasted is about 30. Each patient will have one LP in a seated position and one in a lying position.
Detailed description
In Pediatric Oncology Hematology, invasive procedures such lumbar punctures or myelograms are essential to diseases diagnosis and treatment.
In hematological malignancies, lumbar punctures are particularly frequent as the therapy processes. Despite a good analgesia, this repeated procedure can generate pain, anxiety, apprehension leading to an increasing difficulty in the procedure realization.
Two positions are possible to carry out lumbar puncture: seated or lying position.
The main goal of this study is to assess the impact of the child positioning during the lumbar puncture process in term of pain, anxiety and stress.
This study is a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is 1 year, 30 patients will be included from 2 to 18 years old.
Each patient will have 2 LP one in seated and one in lying position in a specific order determined by randomization.
All data regarding pain and anxiety will be collected the day of LP. Patients will be re contacted 48 hours and 15 days after LP procedure in order to evaluate complications such post-lumbar puncture syndrome or hematoma. The main analysis will be done on intent-to-treat-analysis basis and will compare pain intensity between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LP in a seated position then LP in a lying position | Other | Other: LP in a seated position then LP in a lying positionPatients will have first a lumbar puncture (LP) in a seated position then a LP in a lying position |
| LP in a lying position then LP in a seated position | Other | Other: LP in a lying position then LP in a seated positionPatients will have first a lumbar puncture (LP) in a lying position then a LP in a seated position |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age between 2 and 18 years old
- Patients requiring at least 2 therapeutic lumbar punctures
- Patients able to receive analgesic procedure according to 20005 good practices recommendation
- Presence of one parent during LP procedure
- Child able to use assessment scales
Key exclusion criteria (4 listed)
- Seated or lying position impossible
- Lumbar puncture contraindication
- Patient or parent opposition to second LP realization in the required position
- Clotting trouble on LP day not allowing the LP 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 |
|---|---|---|
| LP in a seated position then LP in a lying position | Other | LP in a seated position then LP in a lying position |
| LP in a lying position then LP in a seated position | Other | LP in a lying position then LP in a seated position |
Primary outcome
Pain sensitivity during the lumbar puncture procedure.
Time frame: duration of the procedure
It will be evaluated throw specific pain assessment scales according to patient age
2 secondary outcomes
Anxiety during the lumbar puncture procedure on a scale of one to ten
Time frame: duration of the procedure
Time of the lumbar puncture procedure
Time frame: duration of the procedure
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 12 Mar 2018.
- 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 LP in a seated position then LP in a lying position and LP in a lying position then LP in a seated position in people with Hematological Malignancies, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 9 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: finished, as of the sponsor's last update on 12 Mar 2018. 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 France. 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?
Pain sensitivity during the lumbar puncture procedure. (time frame: duration of the procedure). 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 12 Mar 2018.