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Women's Interventions for Sexual Health: WISH

NCT05692960 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-19

Study results available
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Summary

The overall objective of this program of research is to improve sexual health outcomes for women diagnosed with breast cancer. Our team is developing a multi-component intervention for the four key predictors of sexual health in female cancer survivors: self-image, vulvovaginal tissue quality and symptoms, desire/energy, and relationship-partner concerns. This proposal begins the proof-of-concept pilot study in women with a history of breast cancer to deliver a multi-component intervention to improve vulvo-vaginal atrophy with a vaginal moisturizer, and sexual energy and self-image with a mind-body intervention that involves relaxation and subconscious suggestions with a hypnotic induction delivered via audio file. The primary outcome will be to evaluate the feasibility and acceptability of a multi-component intervention for sexual function. It is hypothesized that at least eighty percent of randomized participants will complete the study without differential withdraws from the control group.

Conditions

  • Sexual Dysfunction, Physiological
  • Body Image
  • Libido; Loss, Aversion

Interventions

OTHER

Hypnotic Relaxation Intervention (HRI)

HRI is a combination intervention (Replens™ vaginal moisturizer device and hypnotic relaxation behavioral intervention)

DEVICE

Vulvovaginal Atrophy (VVA)

VVA is a standard of care intervention (Replens™ vaginal moisturizer device)

Sponsors & Collaborators

  • Breast Cancer Research Foundation

    collaborator OTHER

  • The University of Tennessee, Knoxville

    lead OTHER

Principal Investigators

  • Noel M Arring, DNP, PhD, RN · University of Tennessee Knoxville

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2024-02-09
Completion
2024-02-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05692960 on ClinicalTrials.gov