Rocking Motion: Physiologic Effect on the Surgical Stress Response
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Psychiatric |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/2/2017 |
| Start Date: | February 1, 2012 |
| End Date: | November 20, 2017 |
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.
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.
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.
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.
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.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
Principal Investigator: Robert L. Massey, PHD, MS, BSN
Phone: 713-792-3704
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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