Pain Quantification and Pain Management in Interventional Radiology (IR)

Pain Clinical Trial

Official title:

Pain Quantification and Management for Standard Interventional Radiology (IR) Procedures With Subsequent Patient Satisfaction Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500942
• Other study ID #: ID02-374
• Status: Completed
• Phase: N/A
• First received: July 12, 2007
• Last updated: August 1, 2012
• Start date: January 2003
• Est. completion date: June 2009

Study information

• Verified date: August 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Intervention

Behavioral:
• Questionnaire
Questionnaires about the pain level experienced during and after standard procedures are performed in the IR.

Locations

Country	Name	City	State
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure and record patients' pain levels before, during, and after standard procedures performed in Interventional Radiology (IR).		6 Years	No
Secondary	To find a standard method of pain management for each procedure type.		6 Years	No

External Links

•   MD Anderson Cancer Center