Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery

Pain Clinical Trial

Official title:

Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593657
• Other study ID #: IRB00019838
• Secondary ID: CCCWFU 01112
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: June 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	4-5 days
Secondary	Immediate effects of the Mindful Movement and Breathing program on reducing postsurgical pain, psychological distress and lung function	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.	4-5 days
Secondary	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	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.	4-5 days