Effects of Rocking on Postoperative Ileus Duration Study

NCT00494806 | Completed Early Phase 1 Results DMC

• 1 other identifier: 2004-0887
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Cancer

Keywords

Postoperative Ileus (POI); Rocking Chair; Abdominal Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

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.

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.

Interventions

Rocking Chair Intervention OTHER

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.

Rocking Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

Results Point of Contact

• Title: Robert L. Massey, PhD, RN
• Organization: MD Anderson Cancer Center

rlmassey@mdanderson.org

713-792-3704

Study Officials

• Robert L. Massey, RN

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 2, 2007
• Study Start: July 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: August 7, 2012
• Results First Posted: November 26, 2009

Record last verified: 2012-07

Locations

US (1)