Clinical trial · Interventional
Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery
NCT01593657CI-TRIAL-00033593completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Surgery by Laparotomy | — | UNRESOLVED | — |
| Gynecologic Malignancy | — | UNRESOLVED | — |
| Lung Function | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Psychological Distress | — | UNRESOLVED | — |
| Surgical Complications | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mindful Movement and Breathing program | Other | — | UNRESOLVED |
| Questionnaire administration | Other | — | UNRESOLVED |
| The Observer Mobility Scale | Procedure | — | UNRESOLVED |
| Volumetric Incentive Spirometry | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mindful Movement and Breathing program
- description
- 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.
- interventionNames
- Other: Mindful Movement and Breathing program
- Other: Questionnaire administration
- Procedure: The Observer Mobility Scale
- Procedure: Volumetric Incentive Spirometry
Primary outcomes (1)
- 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)
- timeFrame
- 4-5 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.