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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 September 16, 2014