Pain Quantification and Pain Management in Interventional Radiology (IR)

Completed

• Conditions: Pain
• Interventions: Behavioral: Questionnaire

• Registration Number: NCT00500942
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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).

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 Timeline

• Study Start: 2003-01
• Study First Submitted: 2007-07-12
• Study First Submitted QC: 2007-07-12
• Study First Posted: 2007-07-13
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Questionnaire	Patients having a standard procedure performed in Interventional Radiology.

Primary Outcome Measures

Name	Time	Method
To measure and record patients' pain levels before, during, and after standard procedures performed in Interventional Radiology (IR).	6 Years

Secondary Outcome Measures

Name	Time	Method
To find a standard method of pain management for each procedure type.	6 Years

Trial Locations

Locations (1)

U.T.M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States