Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery
|ClinicalTrials.gov Identifier: NCT01593657|
Recruitment Status : Completed
First Posted : May 8, 2012
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment||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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery|
|Actual Study Start Date :||May 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593657
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Suzanne Danhauer, PhD||Wake Forest University Health Sciences|