Clinical trial NCT00500942: Pain Quantification and Pain Management in Interventional Radiology (IR)
Official title: Pain Quantification and Management for Standard Interventional Radiology (IR) Procedures With Subsequent Patient Satisfaction Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Interventional Radiology
Pain Quantification
Pain Management
Patient Satisfaction
Questionnaire
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-07-13
Enrollment: 374
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having a standard procedure performed in Interventional Radiology.

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.

Eligibility 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

Primary outcomes:
measure: To measure and record patients' pain levels before, during, and after standard procedures performed in Interventional Radiology (IR).
timeFrame: 6 Years
Secondary outcomes:
measure: To find a standard method of pain management for each procedure type.
timeFrame: 6 Years
Other outcomes:
Locations:
city: Houston
country: United States
facility: U.T.M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Prachee Singh, BS
role: PRINCIPAL_INVESTIGATOR
References: