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Rocking Motion: Physiologic Effect on the Surgical Stress Response

Primary Purpose

Gastrointestinal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Standard of Care
Rocking Chair Motion
Questionnaire
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Cancer focused on measuring Colon Cancer, Abdominal Surgery, Stress, Rocking Motion, Salivary Cortisol, Postoperative Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard of Care Group

Rocking Motion Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Efficacy of Rocking Chair Motion on Surgical-Induced Stress
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.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2010
Last Updated
November 28, 2017
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01200316
Brief Title
Rocking Motion: Physiologic Effect on the Surgical Stress Response
Official Title
Rocking Motion: Physiologic Effect on the Surgical Stress Response
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2012 (Actual)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The standard method used to help the return of bowel function after surgery is to have patient get out of bed, sit in a chair for a period of time, and then begin walking the first day after surgery. Patients are then asked to increase the time they spend sitting in the chair and walking every day. However, it is not clear that this is the best method to assist in the return of normal bowel function. Some studies have shown that rocking in a rocking chair may help normal bowel function to return more quickly. Study Groups: If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group: If you are in Group A, you will use the "rocking chair method." Beginning the first day after surgery, you will sit in a rocking chair and rock back and forth for 10-20 minutes at a time. This will be done for at least 60 minutes (1 hour) per day, until you pass gas for the first time after surgery. The study staff will show the correct method to rock in the rocking chair and give you time to practice while you are in the clinic. If you are in Group B, you will use the standard method only. Beginning the first day after surgery, you will sit in a non-rocking chair for at least 60 minutes each day until you pass gas for the first time after surgery. No matter what group you are in, you will also be asked to begin walking the first day after surgery until you pass gas for the first time after surgery. You will wear an activity recorder all day attached to a wrist band in order to record your time spent in bed, in the rocking or non-rocking chair, and an activity monitor around your waist to record the time and distance walked during each 24-hour period. The study staff will show you how to wear this activity recorder. You will be encouraged by the study staff to increase the time spent in the chair and walking each day. You will be given a pencil and pad of paper to note the date and time you first pass gas after surgery. Study Tests: On the day before you have surgery, the following tests and procedures will be performed: You will be asked to provide demographic information (such as your age and marital status). This information will be coded to protect your privacy. You will complete a questionnaire about any symptoms you may be experiencing. This should take about 10 minutes to complete. Saliva will be collected to measure your cortisol level. For this saliva to be collected, you will spit into a tube. The level of cortisol in your saliva is used to measure your response to stress. Every morning while you are in the hospital and until you pass gas for the first time after surgery: You will be asked if you have passed gas. Saliva will be collected to measure your cortisol level. You will complete the symptom questionnaire. It will take about ten minutes to complete the questionnaire and to collect the saliva sample. You will perform the exercises described in the "Study Groups" section, depending on which group you are assigned to. Length of Study: You will be on study from the first day after surgery until you pass gas (usually about 3-5 days). You will be taken off study if you cannot tolerate rocking in a rocking chair, sitting in a non-rocking chair, or walking, due to discomfort or any other reason. This is an investigational study. There are no additional costs to you for taking part in this study. Up to 80 patients will take part in the study. All will be enrolled at MD Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer
Keywords
Colon Cancer, Abdominal Surgery, Stress, Rocking Motion, Salivary Cortisol, Postoperative Ileus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Rocking Motion Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard of Care
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Rocking Chair Motion
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire
Other Intervention Name(s)
Survey
Intervention Description
Beginning on day of surgery till discharge (3-5 days)
Primary Outcome Measure Information:
Title
Efficacy of Rocking Chair Motion on Surgical-Induced Stress
Description
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.
Time Frame
3 - 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years old Speak and read English Scheduled to undergo abdominal surgery Tolerate sitting in a rocking or nonrocking chair Able to ambulate Scheduled to receive epidural or intravenous patient controlled analgesia Cognitively intact Signed a study-specific informed consent prior to study entry May include patients undergoing ileostomy or colostomy reversal Exclusion Criteria: 1) All others will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin S. Wang, MD, MPH
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

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Rocking Motion: Physiologic Effect on the Surgical Stress Response

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