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Rocking Motion: Physiologic Effect on the Surgical Stress Response

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01200316
First Posted: September 13, 2010
Last Update Posted: November 30, 2017
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.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

After having abdominal surgery, patients often experience a lack of bowel function that can cause nausea, vomiting, abdominal swelling, pain, and/or discomfort. This is known as "post-operative ileus." Patients are usually not allowed to leave the hospital until their doctor is sure that their bowel function has returned.

The goal of this clinical research study is to compare using a rocking chair to the standard of care in improving post-operative ileus after abdominal surgery.


Condition Intervention Phase
Gastrointestinal Cancer Procedure: Standard of Care Procedure: Rocking Chair Motion Behavioral: Questionnaire Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Rocking Motion: Physiologic Effect on the Surgical Stress Response

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

Primary Outcome Measures:
  • Efficacy of Rocking Chair Motion on Surgical-Induced Stress [ Time Frame: 3 - 5 days ]
    Efficacy of rocking chair motion on surgical-induced stress response as measured by salivary cortisol sample collected each morning in two groups of colon cancer patients recovering from abdominal surgery randomized to receive either a rocking chair motion intervention or standard care.


Enrollment: 86
Actual Study Start Date: February 1, 2012
Study Completion Date: November 20, 2017
Primary Completion Date: November 20, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard of Care Group
Post surgical patient to sit in a non-rocking chair for at least sixty minutes per day, and ambulating at least three times per day.
Procedure: Standard of Care
Post surgical patient to sit in a non-rocking chair for at least sixty minutes per day, and ambulating at least three times per day.
Behavioral: Questionnaire
Beginning on day of surgery till discharge (3-5 days)
Other Name: Survey
Experimental: Rocking Motion Group
Post surgical patient to rock in a rocking chair in 10-20 minute increments for at least sixty minutes per day, and ambulating at least three times per day.
Procedure: Rocking Chair Motion
Post surgical patient to rock in a rocking chair in 10-20 minute increments for at least sixty minutes per day, and ambulating at least three times per day.
Behavioral: Questionnaire
Beginning on day of surgery till discharge (3-5 days)
Other Name: Survey

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years old
  2. Speak and read English
  3. Scheduled to undergo abdominal surgery
  4. Tolerate sitting in a rocking or nonrocking chair
  5. Able to ambulate
  6. Scheduled to receive epidural or intravenous patient controlled analgesia
  7. Cognitively intact
  8. Signed a study-specific informed consent prior to study entry
  9. May include patients undergoing ileostomy or colostomy reversal

Exclusion Criteria:

1) All others 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): NCT01200316


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
Investigators
Principal Investigator: Xin S. Wang, MD, MPH M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01200316     History of Changes
Other Study ID Numbers: 2010-0129
NCI-2012-01884 ( Registry Identifier: NCI CTRP )
10445215 ( Other Grant/Funding Number: NINR )
First Submitted: September 9, 2010
First Posted: September 13, 2010
Last Update Posted: November 30, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Colon Cancer
Abdominal Surgery
Stress
Rocking Motion
Salivary Cortisol
Postoperative Ileus

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases