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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
History of Changes
  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
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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:

MedlinePlus related topics: Cancer Gas
U.S. FDA Resources

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). ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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 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: 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
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Abdominal Neoplasms
Ileus
Neoplasms by Site
Neoplasms
 Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013