Abdominal Surgery by Laparotomy, Gynecologic Malignancy, Lung Function, Pain, Psychological Distress, Surgical Complications
Conditions
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.
Interventions
OTHERMindful 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.
OTHERQuestionnaire administration
Collected at baseline (before surgery), before and after each YST session, and at follow-up (two days after surgery).
PROCEDUREThe 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.
PROCEDUREVolumetric Incentive Spirometry
Conducted twice before and after each Mindful Movement and Breathing program to measure lung function. Mean of the two readings used.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed