NCT07023822

WISH, Feasibility of a Factorial Design

Women's Interventions for Sexual Health: WISH, Feasibility of a Factorial Design

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: The University of Tennessee, Knoxville · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this study is to evaluate the feasibility of testing a multi-component intervention for sexual function using a factorial design.

Detailed description

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.

Conditions

• Breast Cancer
• Vulvovaginal Signs and Symptoms
• Sexual Desire Disorder
• Body Image

Interventions

Type	Name	Description
DEVICE	Hyaluronic acid (HLA) Vaginal Moisturizer	Use of vaginal moisturizer every 3 days for weeks 1-8.
DEVICE	Polycarbophil Vaginal Moisturizer	Use of vaginal moisturizer every 3 days for weeks 1-8.
BEHAVIORAL	Hypnotic Relaxation	Listen to hypnotic relaxation audio files at least 3x/week for weeks 3-8.
BEHAVIORAL	Progressive Muscle Relaxation (PMR)	Listen to PMR audio file at least 3x/week for weeks 3-8.

Timeline

• Start date: 2025-06-16
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2025-06-17
• Last updated: 2025-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study