Abdominal CancerEarly Phase 1NCT00494806
Effects of Rocking on Postoperative Ileus Duration Study
A Early Phase 1 study testing Rocking Chair Intervention in people with Abdominal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Abdominal Cancer
- What is being tested?
- Rocking Chair Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Feb 2007
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post abdominal surgical cancer patient, undergoing abdominal surgery
- Over 21 years of age.
- Ambulatory.
- Cognitively intact.
- 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.
Who cannot join
- Postoperative abdominal surgical cancer patient less than 21 years of age.
- Are not ambulatory.
- Are not cognitively intact.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: The Effects of Rocking Chair Motion on Postoperative Ileus Duration, Subjective Pain and Time to Discharge Following Abdominal Surgery
Primary Objective:
- 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.
Read the detailed 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.
- Conditions
- Abdominal Cancer
- Being tested
- Rocking Chair Intervention
- Keywords
- Postoperative Ileus (POI), Rocking Chair, Abdominal Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocking Chair InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rocking Group | Experimental | Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus. Receives: Other: Rocking Chair Intervention |
| Standard Care | No intervention | Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Daily from first day after surgical procedure to passage of first flatus (up to 5 - 7 days post surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study startJul 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert L. Massey, RN, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494806
- Sponsor's protocol ID
- 2004-0887
- Status last verified
- Jul 2012
- First submitted
- 29 Jun 2007
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Rocking Chair Motion on Postoperative Ileus Duration, Subjective Pain and Time to Discharge Following Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00494806
- Acronym / sponsor ID
- 2004-0887
- Conditions
- Abdominal Cancer
- Keywords
- Postoperative Ileus (POI), Rocking Chair, Abdominal Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 2 Jul 2007 (estimated)
- Results
- Posted 26 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocking Group | Experimental | Other: Rocking Chair InterventionPatients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus. |
| Standard Care | No intervention | –Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Post abdominal surgical cancer patient, undergoing abdominal surgery
- Over 21 years of age.
- Ambulatory.
- Cognitively intact.
- 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.
Key exclusion criteria (4 listed)
- Postoperative abdominal surgical cancer patient less than 21 years of age.
- Are not ambulatory.
- Are not cognitively intact.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocking Chair InterventionPatient 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. | Other | Rocking Group |
Primary outcome
Time to First Postoperative Flatus in Days Was the End of Postoperative Ileus (POI) Indicator.
Time frame: Daily from first day after surgical procedure to passage of first flatus (up to 5 - 7 days post surgery).
Time from end of surgical procedure until passage of first postoperative flatus was used as an indicator for resolution of postoperatve ileus (POI).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert L. Massey, RN principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rocking Chair Intervention in people with Abdominal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Postoperative Flatus in Days Was the End of Postoperative Ileus (POI) Indicator. (time frame: Daily from first day after surgical procedure to passage of first flatus (up to 5 - 7 days post surgery).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2012.