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Behavioural Intervention
Hypnotic Relaxation for Sexual Dysfunction (WISH Trial)
N/A
Recruiting
Led By Debra L Barton, PhD,RN,FAAN
Research Sponsored by The University of Tennessee, Knoxville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days screening to consent
Awards & highlights
WISH Trial Summary
This trial will develop an intervention to improve sexual health outcomes for women with breast cancer. It will focus on 4 key predictors: self-image, vulvovaginal quality, desire/energy, & relationship-partner concerns.
Who is the study for?
This trial is for women who've had breast cancer (stages I-III), finished primary treatment between 3 months and 5 years ago, and are experiencing vaginal dryness or pain during sex, body image issues, or low sexual desire since their diagnosis. They must be able to engage in sexual activity and read/write English. Those on stable antidepressant doses can join; however, those with a history of sexual abuse, severe psychiatric disorders, using certain hormone treatments, or participating in other sexual health studies cannot.Check my eligibility
What is being tested?
The WISH trial aims to improve sexual health by testing two interventions: a vaginal moisturizer for vulvovaginal atrophy and an audio-delivered hypnotic relaxation technique to boost self-image and sexual energy. The study will check if these methods are practical and well-received by participants.See study design
What are the potential side effects?
Potential side effects may include discomfort from the use of vaginal moisturizers or unexpected emotional responses to hypnotic relaxation intervention. However, as this is more focused on feasibility rather than clinical outcomes like drug trials, detailed side effects aren't specified.
WISH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days screening to consent
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days screening to consent
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Accrual rate (a measure of feasibility)
Retention rate/Acceptability (a measure of feasibility)
Screen failure rate (a measure of feasibility)
Secondary outcome measures
Breast- Impact of Treatment Scale (BITS)
Female Sexual Function Index (FSFI)
Patient reported outcomes measurement information system (PROMIS) Sexual Function and Satisfaction
WISH Trial Design
2Treatment groups
Experimental Treatment
Group I: Vulvovaginal Atrophy (VVA)Experimental Treatment1 Intervention
This study arm might best be described as standard of care. Vulvovaginal dryness will be treated with a daily moisturizer for two weeks, then every other day for the remaining six weeks. Vaginal moisturizer will be applied at night, before sleep and after all sexual activity. Several moisturizers are available, including vaginal DHEA (IntraRosa®). Due to the need for reproducibility, we have decided to use one non-hormonal vaginal moisturizer, Replens™ moisture, which is a vaginal moisturizer consisting primarily of a purified water, glycerin, and mineral oil. Other ingredients included in the formulation are polycarbophyl, carbomer, homopolymer type B, hydrogenated palm oil glyceride, sorbic acid, sodium hydroxide. The moisturizing gel was determined to be a medical device for marketing by the FDA in 2010. It is non-hormonal (unlike vaginal DHEA) and therefore will be more likely to be acceptable by a broader range of oncology providers.
Group II: Hypnotic Relaxation Intervention (HRI)Experimental Treatment1 Intervention
The hypnotic relaxation intervention consists of three different audio files, each about 20 minutes in length. These three hypnotic inductions build upon each other. The first hypnotic induction audio focuses on relaxation, feelings of wellness, wholeness, strength, and confidence. The second hypnotic induction audio focuses more specifically on body image related to sexuality and being a sexual being. The third hypnotic induction audio focuses on sexual desire, passion, and energy. Each hypnotic induction will be used for two weeks, three times per week for a total of six weeks of hypnosis.
The vaginal moisturizer component of this arm is the same as that described for the VVA study arm.
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Who is running the clinical trial?
The University of Tennessee, KnoxvilleLead Sponsor
83 Previous Clinical Trials
18,529 Total Patients Enrolled
Breast Cancer Research FoundationOTHER
69 Previous Clinical Trials
137,773 Total Patients Enrolled
Debra L Barton, PhD,RN,FAANPrincipal InvestigatorUniversity of Tennessee Knoxville
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a stable dose of antidepressants for at least 30 days.I am not using any form of estrogen (oral, skin patch, or vaginal).I have a psychiatric disorder like depression, bipolar, OCD, or schizophrenia.I can continue my hormone or HER2-targeted therapy while participating in the study.I can use products like lidocaine for comfort during sex.I am able to have sexual intercourse.I currently have a sexual partner.I experience vaginal or vulvar dryness and/or pain during sexual activity.I have experienced negative changes in my body image or sexual desire since my cancer diagnosis.I had breast cancer at stage I, II, or III.I finished my main cancer treatment between 3 months and 5 years ago.
Research Study Groups:
This trial has the following groups:- Group 1: Vulvovaginal Atrophy (VVA)
- Group 2: Hypnotic Relaxation Intervention (HRI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the trial encompass minors, or are participants required to be of legal age?
"According to the criteria for taking part in this clinical trial, eligible patients must be aged between 18 and 99."
Answered by AI
What is the threshold of participation for this medical experiment?
"Correct. Information posted on clinicaltrials.gov shows that this clinical trial is currently enrolling participants, which began being sought out since November 22nd 2022 and was most recently updated on January 19th 2023. The study seeks to recruit 30 patients from one medical centre."
Answered by AI
Is recruitment still ongoing for this experiment?
"Data retrieved from clinicaltrials.gov verifies this medical investigation is currently enrolling volunteers. It was originally listed on November 22nd 2022 and the details were last modified a few months later, January 19th 2023."
Answered by AI
Is it possible for me to partake in this medical study?
"This clinical trial has an eligibility criteria of 18-99 year olds with sexual dysfunction. Approximately 30 people are needed for enrollment."
Answered by AI
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