Effects of Rocking on Postoperative Ileus Duration Study

Abdominal Cancer Clinical Trial

Official title:

The Effects of Rocking Chair Motion on Postoperative Ileus Duration, Subjective Pain and Time to Discharge Following Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494806
• Other study ID #: 2004-0887
• Status: Completed
• Phase: Phase 0
• First received: June 29, 2007
• Last updated: July 31, 2012
• Start date: July 2005
• Est. completion date: February 2007

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

1. Compare the duration of postoperative ileus (POI) duration (time to first flatus), subjective reports of surgical and gas pain, postoperative pain medication (total milligrams per 24 hours) and postoperative recovery time(length of stay) between two groups of abdominal surgery cancer patients receiving either standard postoperative care or standard care plus the rocking intervention.

Description:

Ileus is a lack of bowel function that can cause colic, vomiting, and/or constipation. Research has shown that bowel function slows down and possibly stops working for a short period of time after surgery, usually for 5-7 days. Patients report pain and discomfort from the gas that builds up in their bowel until the time the bowel begins working properly after surgery. During the period the bowel is not working after surgery, patients cannot leave the hospital until their physician is sure that their bowel function has returned. The return in bowel function is usually signaled by the passage of gas from the rectum.

The main method used to help the return of bowel function is to have patients get out of bed, sit in a chair, and begin walking the first day after surgery and increase the time sitting in the chair and walking every day. However, it is not clear that the sitting in a chair and walking are the best methods to assist in a faster return of bowel function.

One method that shows promise in helping the return of bowel function after abdominal surgery is rocking in a rocking chair. Rocking chair motion has demonstrated an earlier return of normal bowel function in mothers after C-Section and women after abdominal hysterectomy (Moore et al.,1995; Thomas et al., 1990). Rocking also has been used to decrease pain, the amount of pain medication needed, and the time spent in the hospital after abdominal surgery.

If you agree to take part in this study, you will be randomly assigned to one of two groups (Group A or B). Participants in Group A will use the rocking chair method. Participants in Group B will not use the rocking chair method. There is an equal chance of being assigned to either group.

Before you take part in this study, you will be asked to complete a survey about the amount of pain you are currently experiencing (the Brief Pain Inventory-Short Form). It should take about 10 minutes to complete the Brief Pain Inventory-Short Form. Completing the pain inventory before your surgery will allow for a better comparison of your pre and postoperative surgical and gas pain. You will be asked to provide some information such as your age and marital status that will be recorded on a coded data sheet. You will also receive an instruction sheet that describes what you need to do in order to participate in the study (Instruction to Subjects Sheet). The study investigator will also demonstrate to those chosen for the rocking group the correct method to rock in the rocking chair and allow them time to practice. He will also demonstrate the correct way to wear the gait belt with the pedometer attached to it.

Participants in Group A will get out of bed beginning the first day after surgery, sit in a rocking chair (at least twice per day), and rock backward and forward at a constant rate of 1 backward and forward rock per second in 10-20 minute increments. This will be done for at least 60 minutes (1 hour) per day. Participants in Group A will also be asked to begin walking at least twice per day beginning the first day after surgery.

Participants in Group B will get out of bed beginning the first day after surgery and sit in a non rocking chair (at least twice per day) for at least sixty minutes. Group B will also be asked to begin walking at least twice per day.

Both groups will wear a pedometer attached to a gait belt worn around their waist in order to record the number of steps taken in a 24-hour period of time. A pedometer will also be attached to each rocking chair in order to record the number of rocks in a 24-hour period. Participants in each group will be encouraged by the research staff to increase the time spent rocking, sitting in the non-rocking chair, and walking each day. You will be given pain medication as needed.

All participants will be given a pencil and pad to note the date and time that they first pass gas from their rectum. A calendar and clock is available in all patient rooms. Every morning, the study investigator will visit you and ask if you have passed gas, record the number of rocks and steps recorded by the pedometers, reset the pedometers, have you complete a Brief Pain Inventory-Short Form pain evaluation, and check on the total amount of pain medication you have received over the last 24 hours. You may increase the time spent rocking and walking as you desire and are encouraged to do so.

If for any reason, you cannot tolerate rocking in a rocking chair, sitting in a non rocking chair or walking because of discomfort or any other reason, you will be removed from the study without penalty.

There is no follow-up testing for this study. The length of this study is from the first day after your surgery until you actually pass gas from the rectum. This time could range from 5 to 7 days after your operation.

This is an investigational study. There are no drugs involved with this study. Rocking, non rocking chairs, and gait belts will be provided by M. D. Anderson and the pedometers by the study investigator at no charge to the participants during the study. A total of 66 patients will take part in this study. All will be enrolled at M. D. Anderson.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Post abdominal surgical cancer patient, undergoing abdominal surgery

2. Over 21 years of age.

3. Ambulatory.

4. Cognitively intact.

5. Scheduled to have epidural analgesia with fentanyl or dilaudid and/or patient controlled analgesia with morphine or dilaudid as their primary mode of postoperative pain control.

Exclusion Criteria:

1. Postoperative abdominal surgical cancer patient less than 21 years of age.

2. Are not ambulatory.

3. Are not cognitively intact.

4. Have any of the following: severe neuromuscular disease, cardiovascular disease, pacemakers, inner-ear disturbances, known peripheral vascular disease that interferes with ambulation, are on sympathetic inhibitory or mood altering drugs. All patients will have epidural and/or patient controlled analgesia as their primary mode of postoperative pain control and those who do not will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Cancer

Intervention

Other:
• Rocking Chair Intervention
Patient out of bed rocking in a rocking chair at a constant rate of one rock cycle per second (back and forth), in ten to twenty minute increments, for at least sixty minutes per day or 3600 rock cycles and ambulate at least twice per day beginning the first postoperative day.

Locations

Country	Name	City	State
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Postoperative Flatus in Days Was the End of Postoperative Ileus (POI) Indicator.	Time from end of surgical procedure until passage of first postoperative flatus was used as an indicator for resolution of postoperatve ileus (POI).	Daily from first day after surgical procedure to passage of first flatus (up to 5 - 7 days post surgery).	No

External Links

•   UT MD Anderson Cancer Center website