Trial Outcomes & Findings for EHealth Mindful Movement and Breathing in Improving Outcomes in Participants Undergoing Gynecologic Surgery (NCT NCT03379376)

Last Updated: 2019-12-30

Results Overview

This is a feasibility study to iteratively refine the eMMB implementation strategies with 10-15 consecutive participants enrolled. Participants will be asked to complete a brief usability questionnaire about their confidence in their ability to complete the intervention. The number of participants will depend on when a consensus is reached on a manual for implementing interventions and will be determined by calculating 95% confidence intervals around all the secondary outcomes.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

Up to 4 weeks

Results posted on

2019-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	Supportive Care (eMMB) Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
Overall Study STARTED	10
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Supportive Care (eMMB) Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
Overall Study Lost to Follow-up	2
Overall Study Did not wish to complete follow up	1
Overall Study Overwhelmed, didn't want to continue	1
Overall Study Death	1

Baseline Characteristics

EHealth Mindful Movement and Breathing in Improving Outcomes in Participants Undergoing Gynecologic Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supportive Care (eMMB) n=10 Participants Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
Age, Continuous	58.2 Years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks

Outcome measures

Outcome measures
Measure	Supportive Care (eMMB) n=10 Participants Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
Number of Participants Confident in the Use of EHealth Format	7 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks

Participants who were recruited and agreed to participate in the Mindful Movement and Breathing (eMMB) sessions and those who completed all assessments will be computed.

Outcome measures

Outcome measures
Measure	Supportive Care (eMMB) n=10 Participants Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
Number of Participants Recruited and Completed All Assessments	5 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks

To be determined by comparing participants who were adherent to attending study visits and interventions by an adherence assessment (1) Completion of the videoconference session; (2) any additional contact with the interventionists; (3) use of the self-directed intervention:

Outcome measures

Outcome measures
Measure	Supportive Care (eMMB) n=10 Participants Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
Number of Participants That Adhered to Study Interventions	7 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks

Adverse events will be reported upon occurrence monthly. Specifically, they will be labeled definitely unrelated, definitely related, probably related, or possibly related to the study intervention.

Outcome measures

Outcome measures
Measure	Supportive Care (eMMB) n=10 Participants Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
Number of Participants Reporting Adverse Events	1 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks

To be assessed by calculating the percent of participants who complete the 4-week visit.

Outcome measures

Outcome measures
Measure	Supportive Care (eMMB) n=10 Participants Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
Percentage of Participants Completing 4-week Visits	5 Participants

Adverse Events

Supportive Care (eMMB)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Supportive Care (eMMB) n=10 participants at risk Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
Infections and infestations Sepsis	10.0% 1/10 • Number of events 1 • Nonserious adverse events will be monitored on a quarterly basis and serious adverse events up to 4 weeks.

Other adverse events

Adverse event data not reported

Additional Information

Meg O'Mara - Study Coordinator

Wake Forest University Health Sciences

Phone: 336-716-5440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place