Adults 18 to 99, female only, with Sexual Dysfunction, Physiological or Body Image. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Screen Failure Rate (a Measure of Feasibility)Primary· Up to 30 days Recruitment to screening
The number of women screened ineligible / number of individuals for whom full eligibility criteria were evaluated
Group
Value
95% CI
All Individuals Contacted
36
Accrual Rate (a Measure of Feasibility)Primary· Up to 30 days Screening to consent
The number of participants who consented divided by the number eligible
Group
Value
95% CI
All Individuals Contacted
30
Retention Rate/Acceptability (a Measure of Feasibility)Primary· Baseline through study completion, 8 weeks
The number of participants who completed the 8 weeks of the study divided by the number who consented.
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
14
Vulvovaginal Atrophy (VVA), Moisturizer Only
16
Female Sexual Function Index (FSFI)Secondary· consent to week 8
The Female Sexual Function Index (FSFI) is a 19-item scale that measures the following domains of female sexual functioning: desire (subscale scale = 1.2-6), arousal (subscale = 0-6), satisfaction (subscale = 0.8-6), orgasm (subscale = 0-6), lubrication (subscale = 0-6) and pain (subscale = 0-6). When the scores of these domains are added together, the sum represents an FSFI total score.
The following subscales were examined in this study: FSFI total (subscale range = 2-36 where higher scores indicate better sexual function); lubrication (subscale = 0-6 where higher scores indicate greater lu
FSFI Total, Baseline
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
14.56
± 5.21
Vulvovaginal Atrophy (VVA), Moisturizer Only
12.82
± 6.97
FSFI Total, Week 8
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
22.35
± 8.21
Vulvovaginal Atrophy (VVA), Moisturizer Only
21.44
± 7.34
FSFI Lubrication, Baseline
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
2.06
± 1.26
Vulvovaginal Atrophy (VVA), Moisturizer Only
1.65
± 1.33
FSFI Lubrication, Week 8
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
3.90
± 1.71
Vulvovaginal Atrophy (VVA), Moisturizer Only
3.92
± 1.76
FSFI Pain, Baseline
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
2.26
± 1.58
Vulvovaginal Atrophy (VVA), Moisturizer Only
1.80
± 1.54
FSFI Pain, Week 8
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
3.54
± 2.13
Vulvovaginal Atrophy (VVA), Moisturizer Only
3.20
± 2.23
FSFI Desire, Baseline
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
2.06
± .84
Vulvovaginal Atrophy (VVA), Moisturizer Only
2.03
± .95
FSFI Desire, Week 8
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
3.17
± 1.09
Vulvovaginal Atrophy (VVA), Moisturizer Only
3.08
± .75
Breast Impact of Treatment Scale (BITS)Secondary· consent to week 8
The Breast Impact of Treatment Scale (BITS) is a 13-item scale that measures body change stress in women with breast cancer. Scores range from 0-65. Higher scores indicate greater body change stress.
BITS, Baseline
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
30.71
± 14.91
Vulvovaginal Atrophy (VVA), Moisturizer Only
35.00
± 16.54
BITS, Week 8
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
19.50
± 14.85
Vulvovaginal Atrophy (VVA), Moisturizer Only
28.81
± 16.67
Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction V2.0 (PROMIS SexF V2 )Secondary· consent to week 8
The PROMIS SexF V2 is a 14-item scale that includes screener items and measures sexual activities, symptoms, functioning, and evaluation of sexual experiences. It includes the following domains: interest in sexual activity, lubrication, vaginal discomfort, clitoral discomfort, labial discomfort, orgasm and pleasure, and satisfaction. Raw scores were converted to t-scores where the mean(standard deviation) = 50(10) in the referent population. Higher scores indicate more of the thing being described. Researchers are encouraged to select the sexual function and satisfaction domains and items that
PROMIS Interest Baseline
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
31.33
± 9.01
Vulvovaginal Atrophy (VVA), Moisturizer Only
35.65
± 7.51
PROMIS Interest Week 8
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
40.34
± 11.10
Vulvovaginal Atrophy (VVA), Moisturizer Only
41.48
± 7.78
PROMIS Lubrication Baseline
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
32.68
± 7.11
Vulvovaginal Atrophy (VVA), Moisturizer Only
34.28
± 6.23
PROMIS Lubrication Week 8
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
45.65
± 9.74
Vulvovaginal Atrophy (VVA), Moisturizer Only
46.11
± 8.63
PROMIS Satisfaction Baseline
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
38.23
± 5.49
Vulvovaginal Atrophy (VVA), Moisturizer Only
39.80
± 4.19
PROMIS Satisfaction Week 8
Group
Value
95% CI
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
44.37
± 8.14
Vulvovaginal Atrophy (VVA), Moisturizer Only
47.16
± 8.26
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were monitored every 2 weeks from week 1 to week 8..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Hypnotic Relaxation Intervention (HRI), Moisturizer and Self Hypnosis
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by The University of Tennessee, Knoxville
Last refreshed: 19 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05692960.