Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery

NCT01593657 | Completed

• 2 other identifiers: IRB00019838CCCWFU 01112
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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)

  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 Outcomes (2)

• Immediate effects of the Mindful Movement and Breathing program on reducing postsurgical pain, psychological distress and lung function

  4-5 days

• 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

Study Arms (1)

Mindful Movement and Breathing program

EXPERIMENTAL

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; Other: Questionnaire administration; Procedure: The Observer Mobility Scale; Procedure: Volumetric Incentive Spirometry

Interventions

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.

Mindful Movement and Breathing program

Questionnaire administration OTHER

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

Mindful Movement and Breathing program

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.

Mindful Movement and Breathing program

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.

Mindful Movement and Breathing program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed protocol specific informed consent
• years of age or older
• Scheduled for a major abdominal gynecological surgery to remove a mass that is suspected to be malignant

You may not qualify if:

• Unable to read or understand English
• Cognitively impaired and/or cannot complete interviews as judged by the referring physician, nurse, or study staff

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzanne Danhauer, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 8, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 3, 2018

Record last verified: 2018-06

Locations

US (1)