Breakthrough PainNCT02437929
Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment
An observational study of Breakthrough Pain and Pain Due to Certain Specified Procedures, run by Antea Foundation at 1 site in Italy.
Trial summary
This study aims to assess self reported procedural pain compared with background pain and evaluate pain intensity differences across six standard procedures. Besides, rescue and preventive treatments used to control procedural pain will be examined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breakthrough Pain, Pain Due to Certain Specified Procedures, Pain
- What is being tested?
- Mobilization, Positioning and Personal Hygiene Care
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,079 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2015to Apr 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Terminally ill patients, cancer and non-cancer, admitted in a palliative care service (inpatients or outpatients), that are undergoing at least one procedure considered in the study, as a part of their Individual Care Plan (ICP).
Who may be able to join
- Patients receiving the procedures included in this study as a part of their standard care
- Patients that have expressed their consent to participate to the study by signing the informed consent document
Who cannot join
- Very serious or unstable clinical conditions with a Karnofsky Performance Status Index (KPS) < 20
- Presence of neurological or psychiatric conditions, due to the original disease or concomitant diseases, interfering with the patient's level of consciousness or with judgment, such as to compromise compliance with the study protocol;
- Not adequately controlled background pain (average NRS in the last 24 hours is > 4)
- Emergency procedures or procedures performed during night time (from 8 p.m. until 8 a.m)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment. A Prospective, Cross-sectional, Multicenter, National Study
This study aims to assess self reported procedural pain compared with background pain and evaluate pain intensity differences across six standard procedures. Besides, rescue and preventive treatments used to control procedural pain will be examined.
- Conditions
- Breakthrough Pain, Pain Due to Certain Specified Procedures, Pain, Cancer, Terminal Disease
- Being tested
- Mobilization, Positioning, Personal Hygiene Care, Bladder catheterization, Wound care
- Medical subject headings
- Breakthrough Pain, Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobilizationProcedure or surgery
PositioningProcedure or surgery
Personal Hygiene CareProcedure or surgery
Bladder catheterizationProcedure or surgery
Wound careProcedure or surgery
Subcutaneous drugs administrationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving standard procedures | Not described Receives: Procedure: Mobilization; Procedure: Positioning; Procedure: Personal Hygiene Care; Procedure: Bladder catheterization; Procedure: Wound care; Procedure: Subcutaneous drugs administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
11 Points - Numerical Rating Scale (NRS); change in baseline pain intensity during the procedure (of 3 points NRS or higher)
Self reported pain intensity 10 minutes before the procedure, during the procedure (measured immediately after that the procedure is performed), 10 minutes after the procedure. Each item is scored 0-10 (0 = no pain; 10 = worst possible pain).
Measured: Participants will be followed 10 minutes before the procedure, for the duration of the procedure and ten minutes after, an expected 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 posted8 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breakthrough 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,079 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antea Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Casale, Medicine, Principal investigator, Antea Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437929
- Sponsor's protocol ID
- PCPP02
- Status last verified
- Dec 2015
- First submitted
- 30 Apr 2015
- Last updated
- 12 Jul 2016
- 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 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment. A Prospective, Cross-sectional, Multicenter, National Study
- ClinicalTrials.gov ID
- NCT02437929
- Acronym / sponsor ID
- PCPP02
- Conditions
- Breakthrough Pain, Pain Due to Certain Specified Procedures, Pain, Cancer, Terminal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,079 participants (actual)
- Lead sponsor
- Antea FoundationUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 May 2015 (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 aims to assess self reported procedural pain compared with background pain and evaluate pain intensity differences across six standard procedures. Besides, rescue and preventive treatments used to control procedural pain will be examined.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving standard procedures | – | Procedure: Mobilization, Procedure: Positioning, Procedure: Personal Hygiene Care, Procedure: Bladder catheterization, Procedure: Wound care, Procedure: Subcutaneous drugs administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Terminally ill patients, cancer and non-cancer, admitted in a palliative care service (inpatients or outpatients), that are undergoing at least one procedure considered in the study, as a part of their Individual Care Plan (ICP).
Key inclusion criteria (2 listed)
- Patients receiving the procedures included in this study as a part of their standard care
- Patients that have expressed their consent to participate to the study by signing the informed consent document
Key exclusion criteria (4 listed)
- Very serious or unstable clinical conditions with a Karnofsky Performance Status Index (KPS) < 20
- Presence of neurological or psychiatric conditions, due to the original disease or concomitant diseases, interfering with the patient's level of consciousness or with judgment, such as to compromise compliance with the study protocol;
- Not adequately controlled background pain (average NRS in the last 24 hours is > 4)
- Emergency procedures or procedures performed during night time (from 8 p.m. until 8 a.m)
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 |
|---|---|---|
| Mobilization | Procedure or surgery | Patients receiving standard procedures |
| Positioning | Procedure or surgery | Patients receiving standard procedures |
| Personal Hygiene Care | Procedure or surgery | Patients receiving standard procedures |
| Bladder catheterization | Procedure or surgery | Patients receiving standard procedures |
| Wound care | Procedure or surgery | Patients receiving standard procedures |
| Subcutaneous drugs administration | Procedure or surgery | Patients receiving standard procedures |
Primary outcome
11 Points - Numerical Rating Scale (NRS); change in baseline pain intensity during the procedure (of 3 points NRS or higher)
Time frame: Participants will be followed 10 minutes before the procedure, for the duration of the procedure and ten minutes after, an expected average of 1 hour
Self reported pain intensity 10 minutes before the procedure, during the procedure (measured immediately after that the procedure is performed), 10 minutes after the procedure. Each item is scored 0-10 (0 = no pain; 10 = worst possible pain).
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 Jul 2016.
- 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.
Giuseppe Casale, Medicine principal investigator
Antea Foundation
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 Breakthrough Pain and Pain Due to Certain Specified Procedures, run by Antea Foundation at 1 site in Italy.
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 2 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 Jul 2016. 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 Italy. 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?
11 Points - Numerical Rating Scale (NRS); change in baseline pain intensity during the procedure (of 3 points NRS or higher) (time frame: Participants will be followed 10 minutes before the procedure, for the duration of the procedure and ten minutes after, an expected average of 1 hour). 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 Jul 2016.