Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01593657
First received: May 2, 2012
Last updated: March 24, 2014
Last verified: March 2013
  Purpose

The purpose of this clinical trial is to understand if women undergoing surgery for a suspected gynecologic malignancy are interested in participating in a Mindful Movement and Breathing program and what the effects of this program are on women and the surgery-related symptoms they experience. Mindful Movement and Breathing programs may be effective for easing distress, post-surgical pain, and other symptoms of surgical procedures.


Condition Intervention Phase
Gynecologic Malignancy
Abdominal Surgery by Laparotomy
Pain
Psychological Distress
Lung Function
Surgical Complications
Other: Mindful Movement and Breathing program
Other: Questionnaire administration
Procedure: The Observer Mobility Scale
Procedure: Volumetric Incentive Spirometry
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Feasibility of implementing and evaluating a Mindful Movement and Breathing Program among women undergoing gynecologic surgery for a suspected malignancy (recruitment, retention, adherence, and program evaluation and acceptability rates) [ Time Frame: 4-5 days ] [ Designated as safety issue: No ]
    The proportion of participants who participated in all YST sessions and those who completed all assessments will be computed and compared to those with incomplete data by demographic characteristics. We will model the relationship between adherence and baseline scores of the measures, as well as change in scores. We will also calculate the proportions and 95% confidence intervals of the items that measure program evaluation and intervention to the Clinical Studies Coordinator, nurses and yoga instructor.


Secondary Outcome Measures:
  • Immediate effects of the Mindful Movement and Breathing program on reducing postsurgical pain, psychological distress and lung function [ Time Frame: 4-5 days ] [ Designated as safety issue: No ]
    Measured using Immediate Effect Visual Analog Scales (VAS) of pain and distress and percent change in inspiratory capacity as assessed with a Volumetric Incentive Spirometer. Assessed for each measure by day using a paired t-test and overall using a mixed effects model on the pre-post change in the measure over time.

  • Collect data on measures that will be used to evaluate the efficacy of the Mindful Movement and Breathing program in a future larger randomized controlled trial [ Time Frame: 4-5 days ] [ Designated as safety issue: No ]
    means and standard deviations of the measures will be calculated to inform sample size calculations for a future study, and to provide descriptive statistics of the sample population.


Enrollment: 10
Study Start Date: May 2012
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindful Movement and Breathing program
Mindful Movement and Breathing program implemented in a hospital room or clinic room three times by a yoga instructor: prior to surgery, one day and two days after surgery.
Other: Mindful Movement and Breathing program
Participate Mindful Movement and Breathing program with an experienced yoga instructor. All movements can be done while in a bed (e.g. turning head, shrugging shoulders, bending knees, etc). Each session lasts approximately 15 minutes.
Other: Questionnaire administration
Collected at baseline (before surgery), before and after each YST session, and at follow-up (two days after surgery).
Procedure: The Observer Mobility Scale
Conducted by nurse and study coordinator prior to surgery and two days after surgery to assess mobility. Will ask patient to turn, sit, stand and walk as they are able.
Procedure: Volumetric Incentive Spirometry
Conducted twice before and after each Mindful Movement and Breathing program to measure lung function. Mean of the two readings used.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed protocol specific informed consent
  • 18 years of age or older
  • Scheduled for a major abdominal gynecological surgery to remove a mass that is suspected to be malignant

Exclusion Criteria:

  • Unable to read or understand English
  • Cognitively impaired and/or cannot complete interviews as judged by the referring physician, nurse, or study staff
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593657

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Suzanne Danhauer, PhD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01593657     History of Changes
Other Study ID Numbers: CCCWFU 01112
Study First Received: May 2, 2012
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014