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Rocking Motion: Physiologic Effect on the Surgical Stress Response


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Cancer

Thank you

Trial Information

Rocking Motion: Physiologic Effect on the Surgical Stress Response


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.

Up to 80 patients will take part in the study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. At least 18 years old

2. Speak and read English

3. Scheduled to undergo abdominal surgery for colon cancer

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. Not currently receiving or have not received steroid medication in the past 30 days

9. Has Stage I - III resectable colon cancer

10. Signed a study-specific informed consent prior to study entry

Exclusion Criteria:

1. Patients currently receiving or have stopped using steroid medications in the last 30
days

2. Patients with ileostomy or colostomy

3. Stage IV colon cancer with unresectable lesions

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Efficacy of Rocking Chair Motion on Surgical-Induced Stress

Outcome 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.

Outcome Time Frame:

3 - 5 days

Safety Issue:

No

Principal Investigator

Robert L. Massey, PHD, MS, BSN

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2010-0129

NCT ID:

NCT01200316

Start Date:

February 2012

Completion Date:

Related Keywords:

  • Gastrointestinal Cancer
  • Colon Cancer
  • Abdominal Surgery
  • Stress
  • Rocking Motion
  • Salivary Cortisol
  • Postoperative Ileus
  • Gastrointestinal Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030