Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery

Not Applicable

Completed

• Conditions: Gynecologic Malignancy; Abdominal Surgery by Laparotomy; Surgical Complications; Psychological Distress; Lung Function; Pain

• Registration Number: NCT01593657
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2012-05-04
• Study First Posted: 2012-05-08
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)	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.

Secondary Outcome Measures

Name	Time	Method
Immediate effects of the Mindful Movement and Breathing program on reducing postsurgical pain, psychological distress and lung function	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	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.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States