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Completed

NCT Number: NCT01593657

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.

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Key information

Conditions

Gynecologic Malignancy Abdominal Surgery by Laparotomy Lung Function Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Psychological Distress Signs and Symptoms Surgical Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindful Movement and Breathing program

Other

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.

Questionnaire Administration

Other

Collected at baseline (before surgery), before and after each YST session, and at follow-up (two days after surgery).

The Observer Mobility Scale

Procedure

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.

Volumetric Incentive Spirometry

Procedure

Conducted twice before and after each Mindful Movement and Breathing program to measure lung function. Mean of the two readings used.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 8, 2012
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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