N/A
N=10
EHealth Mindful Movement and Breathing in Improving Outcomes in Participants Undergoing Gynecologic Surgery
Female Reproductive System Neoplasm · Malignant Female Reproductive System Neoplasm · Malignant Uterine Neoplasm · Ovarian Carcinoma · Ovarian Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT03379376 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Dec 2019
Primary outcome: Primary: Number of Participants Confident in the Use of EHealth Format — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Questionnaire Administration (Other); Supportive Care (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Confident in the Use of EHealth Format |
7 | — |
| SECONDARY Number of Participants Recruited and Completed All Assessments |
5 | — |
| SECONDARY Number of Participants That Adhered to Study Interventions |
7 | — |
| SECONDARY Number of Participants Reporting Adverse Events |
1 | — |
| SECONDARY Percentage of Participants Completing 4-week Visits |
5 | — |
Summary
This trial determines how well eHealth mindful movement and breathing works to improve outcomes in participants undergoing gynecologic surgery. Supportive therapy, such as eHealth mindful movement and breathing, uses techniques that include gentle movements, breathing, and relaxation techniques which may help participants cope with and improve their surgical experiences.
Eligibility Criteria
Inclusion Criteria
- Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a mass that is suspected to be malignant
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- Cognitively able to complete assessments as judged by the study team
- Able to understand, read and write English
Exclusion Criteria
- Have schizophrenia or any other psychotic disorder
- Have a diagnosed sleep disorder including untreated obstructive sleep apnea, periodic limb movement disorder, or restless leg syndrome
Data sourced from ClinicalTrials.gov (NCT03379376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.