Effects of Rocking on Postoperative Ileus Duration Study

This study has been completed.

Study NCT00494806 Information provided by M.D. Anderson Cancer Center

First Received: June 29, 2007 Last Updated: October 22, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Caregiver), Parallel Assignment
Condition:	Abdominal Cancer
Intervention:	Other: Rocking Chair Intervention

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 11/18/05 through 03/05/07. All participants recruited at UT MD Anderson Cancer Center, prior to surgery during their preoperative evaluation in the Anesthesia Assessment and Preoperative centers.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no enrolled participates excluded from the trial prior to assignment to groups. All patients approached accepted participation into the study.

Reporting Groups

	Description
Rocking Chair	Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
Standard Care	Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.

Participant Flow: Overall Study

	Rocking Chair	Standard Care
STARTED	34	32
COMPLETED	34	32
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Rocking Chair	Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
Standard Care	Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.

Baseline Measures

	Rocking Chair	Standard Care	Total
Number of Participants [units: participants]	34	32	66
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	33	31	64
>=65 years	1	1	2
Age [units: years] Mean ± Standard Deviation	56.2 ± 10.1	54.8 ± 11.4	55.6 ± 10.7
Gender [units: participants]
Female	20	13	33
Male	14	19	33
Region of Enrollment [units: participants]
United States	34	32	66

Outcome Measures

1. Primary:

Time to First Postoperative Flatus in Days Was the End of Postoperative Ileus (POI) Indicator. [ Daily from first day after surgical procedure to passage of first flatus (up to 5 - 7 days post surgery). ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Robert L. Massey, PhD, RN
Organization: MD Anderson Cancer Center
phone: 713-792-3704
e-mail: rlmassey@mdanderson.org

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Robert L. Massey, PhD, RN/Director Clinical Nursing )
Study ID Numbers:	2004-0887
Study First Received:	June 29, 2007
Results First Received:	August 31, 2009
Last Updated:	October 22, 2009
ClinicalTrials.gov Identifier:	NCT00494806 History of Changes
Health Authority:	United States: Institutional Review Board