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Spots Global Cancer Trial Database for Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery

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Trial Identification

Brief Title: Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery

Official Title: Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)

Study ID: NCT03681405

Study Description

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 (i.e., 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Contact Details

Name: Stephanie Sohl

Affiliation: Wake Forest University Health Sciences

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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