PainNCT00500942
Pain Quantification and Pain Management in Interventional Radiology (IR)
An observational study of Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: To measure and record patients' pain levels before, during, and after standard procedures performed in IR. To compare different procedures to respective pain levels and patient satisfaction (as determined by questionnaire). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 374 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jun 2009
- 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: Patients having a standard procedure performed in Interventional Radiology.
Who may be able to join
- Scheduled for an IR procedure at UTMDACC
- Lives in the United States (easier to contact patients via phone/mailings)
- English-speaking
- Provide written informed consent
Who cannot join
- Refusal to participate
- Current diagnosis of mental illness, such as psychosis or dementia
- Procedure performed under monitored anesthesia care (MAC), general endotracheal anesthesia (GETA), or local anesthesia care
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Pain Quantification and Management for Standard Interventional Radiology (IR) Procedures With Subsequent Patient Satisfaction Analysis
Primary Objectives:
- To measure and record patients' pain levels before, during, and after standard procedures performed in IR.
- To compare different procedures to respective pain levels and patient satisfaction (as determined by questionnaire).
Read the detailed description
During the IR procedure, nurses commonly ask patients to tell them what their pain level is on a 0-10 scale. For those who participate in the study, these numbers will be used to calculate average pain levels. Study participants will be asked to complete the same 0-10 pain scale during the recovery period until time of discharge or admission to the hospital. According to standard criteria when giving conscious sedation, patients will remain in a communicable state throughout the procedure and during the recovery period prior to discharge, and thus, will be able to express a pain level during these times. The same questionnaire will be given for seven days after the procedure, which will be completed on a self-addressed, stamped postcard to be mailed back to UTMDACC. The last postcard will have a couple of questions about patient satisfaction. Once the last postcard is mailed in, the patient's participation in the study is over. Each questionnaire should take less than 5 minutes to complete.
This is an investigational study. About 374 patients will take part in this study. All will be enrolled at UTMDACC.
- Conditions
- Pain
- Being tested
- Questionnaire
- Keywords
- Interventional Radiology, Pain Quantification, Pain Management, Patient Satisfaction, Questionnaire, Survey
- Medical subject headings
- Pain, Agnosia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaires about the pain level experienced during and after standard procedures are performed in the IR.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients having a standard procedure performed in Interventional Radiology. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure and record patients' pain levels before, during, and after standard procedures performed in Interventional Radiology (IR).
Measured: 6 Years
Secondary outcomes (1)
To find a standard method of pain management for each procedure type.
Measured: 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startJan 2003
- Primary completionJun 2009
- Study completionJun 2009
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 M.D. Anderson Cancer CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prachee Singh, BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500942
- Sponsor's protocol ID
- ID02-374
- Status last verified
- Aug 2012
- First submitted
- 12 Jul 2007
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Quantification and Management for Standard Interventional Radiology (IR) Procedures With Subsequent Patient Satisfaction Analysis
- ClinicalTrials.gov ID
- NCT00500942
- Acronym / sponsor ID
- ID02-374
- Conditions
- Pain
- Keywords
- Interventional Radiology, Pain Quantification, Pain Management, Patient Satisfaction, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 Jul 2007 (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.
Primary Objectives:
- To measure and record patients' pain levels before, during, and after standard procedures performed in IR.
- To compare different procedures to respective pain levels and patient satisfaction (as determined by questionnaire).
Detailed description
During the IR procedure, nurses commonly ask patients to tell them what their pain level is on a 0-10 scale. For those who participate in the study, these numbers will be used to calculate average pain levels. Study participants will be asked to complete the same 0-10 pain scale during the recovery period until time of discharge or admission to the hospital. According to standard criteria when giving conscious sedation, patients will remain in a communicable state throughout the procedure and during the recovery period prior to discharge, and thus, will be able to express a pain level during these times. The same questionnaire will be given for seven days after the procedure, which will be completed on a self-addressed, stamped postcard to be mailed back to UTMDACC. The last postcard will have a couple of questions about patient satisfaction. Once the last postcard is mailed in, the patient's participation in the study is over. Each questionnaire should take less than 5 minutes to complete.
This is an investigational study. About 374 patients will take part in this study. All will be enrolled at UTMDACC.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: QuestionnairePatients having a standard procedure performed in Interventional Radiology. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients having a standard procedure performed in Interventional Radiology.
Key inclusion criteria (4 listed)
- Scheduled for an IR procedure at UTMDACC
- Lives in the United States (easier to contact patients via phone/mailings)
- English-speaking
- Provide written informed consent
Key exclusion criteria (3 listed)
- Refusal to participate
- Current diagnosis of mental illness, such as psychosis or dementia
- Procedure performed under monitored anesthesia care (MAC), general endotracheal anesthesia (GETA), or local anesthesia care
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 |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaires about the pain level experienced during and after standard procedures are performed in the IR. | Behavioural | 1 |
Primary outcome
To measure and record patients' pain levels before, during, and after standard procedures performed in Interventional Radiology (IR).
Time frame: 6 Years
1 secondary outcome
To find a standard method of pain management for each procedure type.
Time frame: 6 Years
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 2 Aug 2012.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Prachee Singh, BS principal investigator
M.D. Anderson Cancer Center
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, run by M.D. Anderson Cancer Center at 1 site in United States.
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 2 Aug 2012. 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 United States. 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 measure and record patients' pain levels before, during, and after standard procedures performed in Interventional Radiology (IR). (time frame: 6 Years). 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 2 Aug 2012.