Effects of Rocking (Induced Relaxation) Study

This study has been terminated.

( Did not reach anticipated accrual, study terminated. )

First Received: June 29, 2007 Last Updated: August 3, 2009 History of Changes

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00494806

Purpose

Primary Objective:

1. Compare the duration of PI (time to first flatus), subjective reports of surgical and gas pain, postoperative pain medication (total milligrams per 24 hours) and postoperative recovery time (length of stay) between two groups of abdominal surgery cancer patients receiving either standard postoperative care or standard care plus the rocking intervention.

Condition	Intervention
Abdominal Cancer	Behavioral: Rocking Intervention

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	The Effects of Rocking (Induced Relaxation) on Postoperative Ileus Duration, Subjective Pain and Time to Discharge Following Abdominal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

U.S. FDA Resources

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

Primary Outcome Measures:

To learn if a rocking chair motion can help to control postoperative ileus, decrease pain and the need for pain medication, and quicken recovery time in patients who have just had abdominal surgery. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	66
Study Start Date:	July 2005
Study Completion Date:	February 2008
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group A Rocking Chair Method.	Behavioral: Rocking Intervention Rocking in a rocking chair as relaxation response to allow for post-surgical bowel function return.
Group B No Rocking Chair Method.

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Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Cancer patient, over 21 years of age, having abdominal surgery requiring an epidural and/or intravenous injection for pain control.

Criteria

Inclusion Criteria:

Post abdominal surgical cancer patient, undergoing abdominal surgery
Over 21 years of age.
Ambulatory.
Cognitively intact.
Scheduled to have epidural analgesia with fentanyl or dilaudid and/or patient controlled abalgesia with morphine or dilaudid as their primary mode of postoperative pain control.

Exclusion Criteria:

Postoperative abdominal surgical cancer patient less than 21 years of age.
Are not ambulatory.
Are not cognitively intact.
Have any of the following: severe neuromuscular disease, cardiovascular disease, pacemakers, inner-ear disturbances, known peripheral vascular disease that interferes with ambulation, are on sympathetic inhibitory or mood altering drugs. All patients will have epidural and/or patient controlled analgesia as their primary mode of postoperative pain control and those who do not will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494806

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:

Robert L. Massey, RN

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Robert L. Massey, PhD, MS, BS/Director Clinical Nursing )
Study ID Numbers:	2004-0887
Study First Received:	June 29, 2007
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00494806 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Postoperative Ileus (PI)
Induced Relaxation
Rocking Chair
Abdominal Cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Abdominal Neoplasms

ClinicalTrials.gov processed this record on November 20, 2009