Rocking Motion: Physiologic Effect on the Surgical Stress Response
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Efficacy of Rocking Chair Motion on Surgical-Induced Stress
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •All others will be excluded.
Arms & Interventions
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.
Intervention: Standard of Care (Procedure)
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.
Intervention: Questionnaire (Behavioral)
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.
Intervention: Rocking Chair Motion (Procedure)
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.
Intervention: Questionnaire (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported