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Effects of Rocking on Postoperative Ileus Duration Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00494806
First Posted: July 2, 2007
Last Update Posted: August 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

Primary Objective:

1. Compare the duration of postoperative ileus (POI) duration (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 Phase
Abdominal Cancer Other: Rocking Chair Intervention Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: The Effects of Rocking Chair Motion on Postoperative Ileus Duration, Subjective Pain and Time to Discharge Following Abdominal Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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). ]
    Time from end of surgical procedure until passage of first postoperative flatus was used as an indicator for resolution of postoperatve ileus (POI).


Enrollment: 66
Study Start Date: July 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rocking Group
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.
Other: Rocking Chair Intervention
Patient out of bed rocking in a rocking chair at a constant rate of one rock cycle per second (back and forth), in ten to twenty minute increments, for at least sixty minutes per day or 3600 rock cycles and ambulate at least twice per day beginning the first postoperative day.
No Intervention: 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.

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  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Postoperative abdominal surgical cancer patient less than 21 years of age.
  2. Are not ambulatory.
  3. Are not cognitively intact.
  4. 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00494806     History of Changes
Other Study ID Numbers: 2004-0887
First Submitted: June 29, 2007
First Posted: July 2, 2007
Results First Submitted: August 31, 2009
Results First Posted: November 26, 2009
Last Update Posted: August 7, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Postoperative Ileus (POI)
Rocking Chair
Abdominal Cancer