ClinicalTrials.Veeva

Menu

Heart Rate Variability Biofeedback for Female Sexual Arousal Disorder

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Female Sexual Arousal Disorder

Treatments

Behavioral: Autogenic Training
Behavioral: HRV Biofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT02958176
2016-08-0074

Details and patient eligibility

About

Low resting heart rate variability (HRV) has been associated with sexual arousal problems and overall sexual dysfunction in women. Research has indicated that HRV biofeedback leads to increases in HRV as well as improvements in symptoms associated with several psychological disorders, some of which are comorbid with sexual arousal problems in women. Autogenic training also facilitates increases in HRV and was recently associated with acute increases in sexual arousal among sexually healthy women. The primary aim of the current study is to examine the efficacy of HRV biofeedback, with and without autogenic training, for the treatment of female sexual arousal disorder (FSAD).

Full description

Women who meet ICD-10-CM diagnostic criteria for FSAD will be recruited and randomized into one of three conditions, HRV biofeedback (n = 25), HRV biofeedback plus autogenic training (n = 25), or wait-list control (n = 15). All participants will complete a baseline assessment, during which their resting state HRV and vaginal pulse amplitude (VPA) will be measured. The participants in the two biofeedback conditions will receive training in HRV biofeedback from the experimenter, and they will be provided with the materials necessary to guide self-practice in HRV biofeedback at home. Participants in these two conditions will be instructed to engage in at-home HRV biofeedback (with or without autogenic training) at least 5 times over a period of two weeks, during which they will report levels of arousal in a sexual activity diary. Participants in the wait-list control condition will report levels of arousal in a sexual activity diary. After two weeks, participants in all three conditions will return to the laboratory, where their physiological and psychological sexual arousal will be measured. Over the next two weeks, participants in the two biofeedback conditions will be asked to complete 5 more self-guided biofeedback sessions along with the sexual activity diary. Participants in all three conditions will return to the lab for a final assessment to measure post-treatment HRV and VPA levels as well as psychological sexual arousal. To our knowledge, this study will be the first randomized controlled trial of HRV biofeedback in women with sexual arousal problems. If the intervention increases arousal in this population, this study may offer a promising cost-effective psychosocial treatment for women with sexual arousal problems.

Enrollment

65 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Premenopausal (18-40 years)
  • Fluent in English
  • Heterosexual or bisexual
  • Score of 26.55 or less on the Female Sexual Function Index (FSFI)
  • Current sexual arousal dysfunction
  • Ownership of an Elite HRV compatible device (recent iPhone, iPad, or Android)

Exclusion criteria

  • Pregnant or breastfeeding
  • History of or current sexually transmitted infections
  • History of major pelvic surgery
  • History of childhood sexual abuse
  • Currently taking androgens, estrogens, or other medical treatments to enhance sexual arousal
  • Current psychosis
  • If on antidepressants or antihypertensives, must be stabilized for at least 3 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

65 participants in 3 patient groups

HRV Biofeedback
Experimental group
Description:
At home HRV biofeedback using mobile device
Treatment:
Behavioral: HRV Biofeedback
HRV Biofeedback with Autogenic Training
Experimental group
Description:
At home HRV biofeedback using mobile device plus autogenic training recording
Treatment:
Behavioral: HRV Biofeedback
Behavioral: Autogenic Training
Wait List
No Intervention group
Description:
Wait list control

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems