Rocking Motion: Physiologic Effect on the Surgical Stress Response

This study is currently recruiting participants.
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01200316
First received: September 9, 2010
Last updated: April 14, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Rocking Motion: Physiologic Effect on the Surgical Stress Response

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Primary Completion Date: February 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Exclusion Criteria:

1) Patients with ileostomy or colostomy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200316

Contacts
Contact: Robert L. Massey, PHD, MS, BSN 713-792-3704

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Robert L. Massey, PHD, MS, BSN    713-792-3704      
Principal Investigator: Robert L. Massey, PHD, MS, BSN         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Robert L. Massey, PHD, MS, BSN UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01200316     History of Changes
Other Study ID Numbers: 2010-0129, NCI-2012-01884
Study First Received: September 9, 2010
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014