PainMUCODOLNCT04561973
Pain in Patients With Cystic Fibrosis in Rouen University Hospital
An observational study of Pain and Cystic Fibrosis, run by University Hospital, Rouen at 1 site in France.
Trial summary
Objectif Principal To evaluate the intensity and frequency of pain episodes in patients with cystic fibrosis followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France. Objectifs secondaires To assess the relationship between pain and disease severity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Cystic Fibrosis
- What is being tested?
- numerical rating scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 109 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2019to 1 Nov 2020
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children and adults followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France
Who may be able to join
- Children and adults followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France.
- Seen for routine planned visits.
- Having expressed their non-opposition or whose non-opposition was expressed by the parents or legal representatives for minors
Who cannot join
- Patients seen for an acute episode or exacerbation outside of routine planned visits or patient hospitalized.
- Major patient under legal protection.
- Major patient having problems understanding the oral and written French language or child whose parents or legal representatives have problems understanding the oral and written French language.
Trial locations and contacts
1 site in 1 country.
About this study
Objectif Principal
- To evaluate the intensity and frequency of pain episodes in patients with cystic fibrosis followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France.
Objectifs secondaires
- To assess the relationship between pain and disease severity.
- To assess the relationship between pain and the age of the patient.
- To describe the pain locations.
- To describe the use of pharmacological or nonpharmacological treatment.
- To evaluate the procedural pain.
Read the detailed description
Patients seen for routine planned visits complete a self-administered retrospective questionnaire about pain during the last 3 months, and a prospective diary during the two weeks following the visit.
Primary evaluation criteria :
Intensity and frequency of pain are evaluated with the prospective diary.
- The pain intensity is assessed by validated scales adapted to the patient's age (scale ranging from 0 to 10). 0 to 6 years : numerical rating scale assessed by the parents. 4 to 7 years : Faces Pain Scale Revised. Children 6 years and older, adolescents and adults: numerical rating scale self-reported
- The pain frequency is completed twice a day (morning and evening) on the prospective pain diary.
Secondary evaluation criteria
- The disease severity, estimated using recent forced expiratory volume in one second (FEV1) (best measurement of the year before bronchodilator, collected in the patient's medical record)
- Pain locations, pharmacological or nonpharmacological treatment and procedural pain are evaluated using the diary and the questionnaire.
- Demographic data and characteristics of cystic fibrosis are collected using the medical file.
- Conditions
- Pain, Cystic Fibrosis
- Being tested
- numerical rating scale
- Keywords
- pain, cystic fibrosis, epidemiology, adults, children
- Medical subject headings
- Pain, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
numerical rating scaleBehavioural
Patients seen for routine planned visits complete a self-administered retrospective questionnaire about pain during the last 3 months, and a prospective diary during the two weeks following the visit.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the intensity and frequency of pain episodes in patients with cystic fibrosis followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France
Intensity and frequency of pain are evaluated with the prospective diary. The pain intensity is assessed by validated scales adapted to the patient's age (scale ranging from 0 to 10).
0 to 6 years : numerical rating scale assessed by the parents. 4 to 7 years : Faces Pain Scale Revised. Children 6 years and older, adolescents and adults: numerical rating scale self-reported The pain frequency is completed twice a day (morning and evening) on the prospective pain diary.
Measured: 14 days
Secondary outcomes (5)
To assess the correlation between pain and disease severity
The disease severity is estimated using recent forced expiratory volume in one second (FEV1) (best measurement of the year before bronchodilator), collected in the patient's medical record. The correlation between pain and the disease severity will be studied with a Spearman's correlation coefficient.
Measured: 14 days
To assess the correlation between pain and the age of the patient.
Age of the patient is collected using the medical file. The correlation between pain and the age will be studied with a Spearman's correlation coefficient.
Measured: 14 days
To describe the pain locations.
Pain locations are evaluated using the prospective diary and the self-administered retrospective questionnaire.
Measured: 14 days
To describe the use of pharmacological or nonpharmacological treatment.
The pharmacological or nonpharmacological treatments are evaluated using the prospective diary (did you take a treatment for that pain episode ?) and the self-administered retrospective questionnaire. The efficacity of the treatment is evaluated with the diary (relief or not) et the questionnaire (Likert-type rating scale : Always, often, rarely, never).
Measured: 14 days
To evaluate the procedural pain.
The procedural pain and the proposed pain treatment are evaluated using the self-administered retrospective questionnaire.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start4 Nov 2019
- Primary completion15 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561973
- Sponsor's protocol ID
- 2019/318/OB
- Acronym
- MUCODOL
- Status last verified
- May 2021
- First submitted
- 14 Sep 2020
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain in Patients With Cystic Fibrosis in Rouen University Hospital
- ClinicalTrials.gov ID
- NCT04561973
- Acronym / sponsor ID
- MUCODOL / 2019/318/OB
- Conditions
- Pain, Cystic Fibrosis
- Keywords
- pain, cystic fibrosis, epidemiology, adults, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 24 Sep 2020 (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.
Objectif Principal
- To evaluate the intensity and frequency of pain episodes in patients with cystic fibrosis followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France.
Objectifs secondaires
- To assess the relationship between pain and disease severity.
- To assess the relationship between pain and the age of the patient.
- To describe the pain locations.
- To describe the use of pharmacological or nonpharmacological treatment.
- To evaluate the procedural pain.
Detailed description
Patients seen for routine planned visits complete a self-administered retrospective questionnaire about pain during the last 3 months, and a prospective diary during the two weeks following the visit.
Primary evaluation criteria :
Intensity and frequency of pain are evaluated with the prospective diary.
- The pain intensity is assessed by validated scales adapted to the patient's age (scale ranging from 0 to 10). 0 to 6 years : numerical rating scale assessed by the parents. 4 to 7 years : Faces Pain Scale Revised. Children 6 years and older, adolescents and adults: numerical rating scale self-reported
- The pain frequency is completed twice a day (morning and evening) on the prospective pain diary.
Secondary evaluation criteria
- The disease severity, estimated using recent forced expiratory volume in one second (FEV1) (best measurement of the year before bronchodilator, collected in the patient's medical record)
- Pain locations, pharmacological or nonpharmacological treatment and procedural pain are evaluated using the diary and the questionnaire.
- Demographic data and characteristics of cystic fibrosis are collected using the medical file.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adults followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France
Key inclusion criteria (3 listed)
- Children and adults followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France.
- Seen for routine planned visits.
- Having expressed their non-opposition or whose non-opposition was expressed by the parents or legal representatives for minors
Key exclusion criteria (3 listed)
- Patients seen for an acute episode or exacerbation outside of routine planned visits or patient hospitalized.
- Major patient under legal protection.
- Major patient having problems understanding the oral and written French language or child whose parents or legal representatives have problems understanding the oral and written French language.
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 |
|---|---|---|
| numerical rating scalePatients seen for routine planned visits complete a self-administered retrospective questionnaire about pain during the last 3 months, and a prospective diary during the two weeks following the visit. | Behavioural | – |
Primary outcome
To evaluate the intensity and frequency of pain episodes in patients with cystic fibrosis followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France
Time frame: 14 days
Intensity and frequency of pain are evaluated with the prospective diary. The pain intensity is assessed by validated scales adapted to the patient's age (scale ranging from 0 to 10). 0 to 6 years : numerical rating scale assessed by the parents. 4 to 7 years : Faces Pain Scale Revised. Children 6 years and older, adolescents and adults: numerical rating scale self-reported The pain frequency is completed twice a day (morning and evening) on the prospective pain diary.
5 secondary outcomes
To assess the correlation between pain and disease severity
Time frame: 14 days
To assess the correlation between pain and the age of the patient.
Time frame: 14 days
To describe the pain locations.
Time frame: 14 days
To describe the use of pharmacological or nonpharmacological treatment.
Time frame: 14 days
To evaluate the procedural pain.
Time frame: 3 months
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 21 Feb 2022.
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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?
An observational study of Pain and Cystic Fibrosis, run by University Hospital, Rouen 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 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 21 Feb 2022. 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?
To evaluate the intensity and frequency of pain episodes in patients with cystic fibrosis followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France (time frame: 14 days). 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 21 Feb 2022.