The primary aim of this study is to evaluate the feasibility of testing a multi-component intervention for sexual function using a factorial design.
This proposal builds upon a multi-component pilot study (WISH), where women with a history of breast cancer participated in a two-component intervention to improve vulvovaginal atrophy with a vaginal moisturizer and sexual desire and body image with Hypnotic Relaxation (HR), a mind-body intervention that includes suggestions for relaxation, improved sexual desire, and body image delivered via audio file. This study seeks to further test WISH by expanding vulvovaginal atrophy interventions to include either a polycarbophil-based vaginal moisturizer (Replens™) or a hyaluronic acid-based moisturizer (HYALO GYN ®); and hypnosis relaxation (HR) or progressive muscle relaxation (PMR) interventions for sexual desire and body image. The primary outcome is the feasibility of a multi-component intervention for sexual function using a factorial design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
18
Use of vaginal moisturizer every 3 days for weeks 1-8.
Use of vaginal moisturizer every 3 days for weeks 1-8.
Listen to hypnotic relaxation audio files at least 3x/week for weeks 3-8.
University of Tennessee, College of Nursing
Knoxville, Tennessee, United States
Accrual Rate
The number of women who consented to participate in the study divided by the number who were eligible and educated about the study.
Time frame: Screening to consent, up to 30 days.
Retention Rate
The number of women who complete all 8 weeks of the study and complete the PROMIS SFS at baseline and at eight weeks divided by the number who are randomized and begin study treatment.
Time frame: Consent through study completion, an average of 8 weeks.
Adherence Rate, Moisturizer
The number of moisturizer uses completed by participants divided by the total number of possible moisturizer uses.
Time frame: Consent through study completion, an average of 8 weeks.
Adherence Rate, Relaxation Intervention
The number of times participant listened to assigned relaxation audio file (hypnosis or PMR) divided by the total number of possible listens.
Time frame: Consent through study completion, an average of 8 weeks.
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Listen to PMR audio file at least 3x/week for weeks 3-8.