Gynecologic MalignancyNCT01593657
Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery
A study testing Mindful Movement and Breathing program, Questionnaire administration and The Observer Mobility Scale in people with Gynecologic Malignancy and Abdominal Surgery by Laparotomy, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Malignancy, Abdominal Surgery by Laparotomy, Pain
- What is being tested?
- Mindful Movement and Breathing program, Questionnaire administration and The Observer Mobility Scale
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to read or understand English
- Cognitively impaired and/or cannot complete interviews as judged by the referring physician, nurse, or study staff
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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
- Being tested
- Mindful Movement and Breathing program, Questionnaire administration, The Observer Mobility Scale, Volumetric Incentive Spirometry
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Movement and Breathing programOther
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 administrationOther
Collected at baseline (before surgery), before and after each YST session, and at follow-up (two days after surgery).
The Observer Mobility ScaleProcedure or surgery
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 SpirometryProcedure or surgery
Conducted twice before and after each Mindful Movement and Breathing program to measure lung function. Mean of the two readings used.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mindful Movement and Breathing program; Other: Questionnaire administration; Procedure: The Observer Mobility Scale; Procedure: Volumetric Incentive Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-5 days
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: 4-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic MalignancyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Danhauer, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593657
- Sponsor's protocol ID
- IRB00019838
- Other IDs
- CCCWFU 01112
- Status last verified
- Jun 2018
- First submitted
- 2 May 2012
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT01593657
- Acronym / sponsor ID
- IRB00019838
- Conditions
- Gynecologic Malignancy, Abdominal Surgery by Laparotomy, Pain, Psychological Distress, Lung Function, Surgical Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindful Movement and Breathing program | Experimental | Other: Mindful Movement and Breathing program, Other: Questionnaire administration, Procedure: The Observer Mobility Scale, Procedure: Volumetric Incentive SpirometryMindful 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to read or understand English
- Cognitively impaired and/or cannot complete interviews as judged by the referring physician, nurse, or study staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Movement and Breathing programParticipate 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. | Other | Mindful Movement and Breathing program |
| Questionnaire administrationCollected at baseline (before surgery), before and after each YST session, and at follow-up (two days after surgery). | Other | Mindful Movement and Breathing program |
| The Observer Mobility ScaleConducted 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. | Procedure or surgery | Mindful Movement and Breathing program |
| Volumetric Incentive SpirometryConducted twice before and after each Mindful Movement and Breathing program to measure lung function. Mean of the two readings used. | Procedure or surgery | Mindful Movement and Breathing program |
Primary outcome
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.
2 secondary outcomes
Immediate effects of the Mindful Movement and Breathing program on reducing postsurgical pain, psychological distress and lung function
Time frame: 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
Time frame: 4-5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Danhauer, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Movement and Breathing program, Questionnaire administration and The Observer Mobility Scale in people with Gynecologic Malignancy and Abdominal Surgery by Laparotomy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 4-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.