Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery

NCT ID: NCT01593657

Last Updated: 2018-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mindful Movement and Breathing program

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.

Group Type EXPERIMENTAL

Mindful Movement and Breathing program

Intervention Type 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

Intervention Type OTHER

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

The Observer Mobility Scale

Intervention Type 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

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type OTHER

Questionnaire administration

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

Intervention Type OTHER

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.

Intervention Type PROCEDURE

Volumetric Incentive Spirometry

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suzanne Danhauer, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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CCCWFU 01112

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00019838

Identifier Type: -

Identifier Source: org_study_id

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