Ignite Creation Date:
2024-05-06 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03681405
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2018-08-31
Brief Title:
Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Support for Optimal Recovery Following Gynecologic Surgery Study SOARING
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial studies how well two different supportive programs work in supporting optimal recovery in participants undergoing gynecological surgery Supportive programs use different methods for helping participants cope with the surgical experience including gentle movements counseling writing or relaxation techniques and may help improve participants well-being after gynecological surgery
Detailed Description:
PRIMARY OBJECTIVES
I To calculate recruitment adherence assessment completion and retention rates
SECONDARY OBJECTIVES
I Document the frequency of adverse events II Assess descriptive data on proposed outcomes ie pain sleep disturbances psychological distress for the next phase of study III Qualitatively assess acceptability to guide future study planning
OUTLINE Participants are randomized to 1 of 2 groups
GROUP I MINDFUL MOVEMENT AND BREATHING eMMB Participants will receive instruction on awareness meditation breathing and relaxation and awareness meditation This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery
GROUP II ATTENTION CONTROL AC Participants will receive caring attention This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery
I To calculate recruitment adherence assessment completion and retention rates
SECONDARY OBJECTIVES
I Document the frequency of adverse events II Assess descriptive data on proposed outcomes ie pain sleep disturbances psychological distress for the next phase of study III Qualitatively assess acceptability to guide future study planning
OUTLINE Participants are randomized to 1 of 2 groups
GROUP I MINDFUL MOVEMENT AND BREATHING eMMB Participants will receive instruction on awareness meditation breathing and relaxation and awareness meditation This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery
GROUP II ATTENTION CONTROL AC Participants will receive caring attention This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA012197 | NIH | Wake Forest University Health Sciences | httpsreporternihgovquickSearchP30CA012197 |
| NCI-2018-01801 | REGISTRY | None | None |
| CCCWFU 97218 | OTHER | None | None |