- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01200316
Rocking Motion: Physiologic Effect on the Surgical Stress Response
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- University of Texas MD Anderson Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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:
1) All others will be excluded.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
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.
Beginning on day of surgery till discharge (3-5 days)
Andre navne:
|
Eksperimentel: 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.
|
Beginning on day of surgery till discharge (3-5 days)
Andre navne:
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Efficacy of Rocking Chair Motion on Surgical-Induced Stress
Tidsramme: 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.
|
3 - 5 days
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Xin S. Wang, MD, MPH, M.D. Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2010-0129
- NCI-2012-01884 (Registry Identifier: NCI CTRP)
- 10445215 (Andet bevillings-/finansieringsnummer: NINR)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Gastrointestinal kræft
-
AstraZenecaJohnson & Johnson K.K. Medical CompanyAfsluttetGastrointestinal endoskopi | Gastrointestinal polypektomiJapan
-
University of AarhusMotilis,SwitzerlandAfsluttetMavetømning | Gastrointestinal Motilitet | Total gastrointestinal transittid | Segmentel transittidDanmark
-
Massachusetts General HospitalTilmelding efter invitationGastrointestinal dysfunktion | Gastrointestinal sygdomForenede Stater
-
Advanced Endoscopy Research, Robert Wood Johnson...Tilmelding efter invitationGastrointestinal dysfunktion | Galdevejssygdomme | Gastrointestinal kræft | Gastrointestinal sygdom | Pancreas sygdom | Gastrointestinal infektion | Gastrointestinal fistel | Gastrointestinal lidelse | Gastrointestinal skade | Terapeutisk endoskopisk ultralyd | Avanceret endoskopi | Terapeutisk endoskopi | Interventionel... og andre forholdForenede Stater
-
University Hospitals of North Midlands NHS TrustIkke rekrutterer endnuGastrointestinal dysfunktionDet Forenede Kongerige
-
Istanbul UniversityRekruttering
-
Second Affiliated Hospital, School of Medicine,...RekrutteringGastrointestinal endoskopiKina
-
Abbott NutritionAfsluttet
-
Colorado State UniversityArcher Daniels Midland CompanyAktiv, ikke rekrutterendeGastrointestinal dysfunktionForenede Stater
-
The Affiliated Hospital of Qingdao UniversityAfsluttetGastrointestinal endoskopiKina
Kliniske forsøg med Standard of Care
-
M.D. Anderson Cancer CenterRekrutteringLungekræft | Gastrointestinal kræftForenede Stater
-
Rhizen Pharmaceuticals SAIncozen Therapeutics Pvt LtdAfsluttet
-
University of Alabama at BirminghamTrukket tilbageFysisk aktivitetForenede Stater
-
University of FloridaPatient-Centered Outcomes Research InstituteAktiv, ikke rekrutterendeProstatakræftForenede Stater
-
NRG OncologyNational Cancer Institute (NCI); Alliance for Clinical Trials in Oncology; Eastern Cooperative Oncology Group og andre samarbejdspartnereRekrutteringHER2-positiv brystkræftForenede Stater, Puerto Rico
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Neuromed IRCCS; Fondazione IRCCS Istituto Neurologico Nazionale Casmiro... og andre samarbejdspartnereRekrutteringSygeplejerske-patient relationer | Atypisk Parkinsonisme | MSA - Multiple System Atrophy | Sygeplejerske Læge Relationer | PSPItalien
-
The Cleveland ClinicSanten Inc.Aktiv, ikke rekrutterende
-
Henry M. Jackson Foundation for the Advancement...Boston University; Kenya Medical Research Institute; Kenya Ministry of Health og andre samarbejdspartnereAfsluttet
-
Stanford UniversityAfsluttetNeonatal hypoglykæmiForenede Stater