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Effects of Rocking on Postoperative Ileus Duration Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00494806
First received: June 29, 2007
Last updated: July 31, 2012
Last verified: July 2012
Results First Received: August 31, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Caregiver);   Primary Purpose: Treatment
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.
Total Total of all reporting groups

Baseline Measures
   Rocking Chair   Standard Care   Total 
Overall Participants Analyzed 
[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.   [ Time Frame: Daily from first day after surgical procedure to passage of first flatus (up to 5 - 7 days post surgery). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00494806     History of Changes
Other Study ID Numbers: 2004-0887
Study First Received: June 29, 2007
Results First Received: August 31, 2009
Last Updated: July 31, 2012