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Pain Quantification and Pain Management in Interventional Radiology (IR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00500942
First received: July 12, 2007
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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).

Condition Intervention
Pain
 Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pain Quantification and Management for Standard Interventional Radiology (IR) Procedures With Subsequent Patient Satisfaction Analysis

Resource links provided by NLM:

MedlinePlus related topics: X-Rays
U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To measure and record patients' pain levels before, during, and after standard procedures performed in Interventional Radiology (IR). [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To find a standard method of pain management for each procedure type. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Enrollment: 374
Study Start Date: January 2003
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients having a standard procedure performed in Interventional Radiology.
 Behavioral: Questionnaire
Questionnaires about the pain level experienced during and after standard procedures are performed in the IR.
Other Name: Survey

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients having a standard procedure performed in Interventional Radiology.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500942

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Prachee Singh, BS M.D. Anderson Cancer Center
  More Information

Additional Information:
MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00500942     History of Changes
Other Study ID Numbers: ID02-374
Study First Received: July 12, 2007
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Interventional Radiology
Pain Quantification
Pain Management
 Patient Satisfaction
Questionnaire
Survey

ClinicalTrials.gov processed this record on May 21, 2013