NCT01200316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2017

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

5.8 years

First QC Date

September 9, 2010

Last Update Submit

November 28, 2017

Conditions

Gastrointestinal Cancer

Keywords

Colon CancerAbdominal SurgeryStressRocking MotionSalivary CortisolPostoperative Ileus

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Rocking Chair Motion on Surgical-Induced Stress

    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

Study Arms (2)

Standard of Care Group

EXPERIMENTAL

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.

Procedure: Standard of CareBehavioral: Questionnaire

Rocking Motion Group

EXPERIMENTAL

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.

Procedure: Rocking Chair MotionBehavioral: Questionnaire

Interventions

Standard of CarePROCEDURE

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.

Standard of Care Group
Rocking Chair MotionPROCEDURE

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.

Rocking Motion Group
QuestionnaireBEHAVIORAL

Beginning on day of surgery till discharge (3-5 days)

Also known as: Survey
Rocking Motion GroupStandard of Care Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \) All others will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Gastrointestinal NeoplasmsColonic Neoplasms

Interventions

Standard of CareSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColorectal NeoplasmsIntestinal NeoplasmsColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Xin S. Wang, MD, MPH

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 13, 2010

Study Start

February 1, 2012

Primary Completion

November 20, 2017

Study Completion

November 20, 2017

Last Updated

November 30, 2017

Record last verified: 2017-11

Locations

US(1)