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Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01593657
First received: May 2, 2012
Last updated: July 28, 2017
Last verified: March 2016
May 2, 2012
July 28, 2017
May 2012
March 2013   (Final data collection date for primary outcome measure)
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 ]
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.
Same as current
Complete list of historical versions of study NCT01593657 on ClinicalTrials.gov Archive Site
  • Immediate effects of the Mindful Movement and Breathing program on reducing postsurgical pain, psychological distress and lung function [ Time Frame: 4-5 days ]
    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 ]
    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.
Same as current
Not Provided
Not Provided
 
Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery
Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Gynecologic Malignancy
  • Abdominal Surgery by Laparotomy
  • Pain
  • Psychological Distress
  • Lung Function
  • Surgical Complications
  • 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.
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.
Interventions:
  • Other: Mindful Movement and Breathing program
  • Other: Questionnaire administration
  • Procedure: The Observer Mobility Scale
  • Procedure: Volumetric Incentive Spirometry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
March 2013
March 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01593657
CCCWFU 01112
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Wake Forest University Health Sciences
Wake Forest University Health Sciences
Not Provided
Principal Investigator: Suzanne Danhauer, PhD Wake Forest University Health Sciences
Wake Forest University Health Sciences
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP