Female Orgasmic DisorderNCT06187246
Avatar-based Therapy for Female Orgasmic Disorder
A study testing Avatar-based intervention and Individual informative talks in people with Female Orgasmic Disorder, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
A randomized controlled trial was conducted for testing the efficacy of a novel avatar-based intervention (IG), that was compared with a control group (CG) for women with female orgasmic disorder (FOD). Participants were 31 women who were randomly assigned to the intervention or the control conditions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Orgasmic Disorder
- What is being tested?
- Avatar-based intervention and Individual informative talks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present the characteristics to diagnose female orgasm disorder after a clinic assessment (considering natural characteristics of the women's sexual response cycle (Conn \& Hodges, 2022) based on the DSM-5 criteria.
- Provide a medical check to prove the absence of physical factors that may be the cause of the orgasm dysfunction, as this is the first part to diagnose FOD.
- Be at least 18 years old (adult).
- Have access to a computer with the characteristics to run Second Life and internet connection.
Who cannot join
- Present a diagnosis of a physical condition that may be the cause of the orgasm dysfunction (e.g., genital lesions, systemic and hormonal factors, vulvovaginal atrophy).
- Presence of other psychological pathology (e.g., depression, trauma) that may be the cause of the orgasm dysfunction.
- Have alcohol dependence (i.e., evaluated during the clinical assessment, according to the diagnostic criteria from the DSM-5, to determine if the individual meets the criteria for an alcohol use disorder diagnosis).
- Drug use, including medication that is known to cause sexual difficulties (e.g., selective serotonin reuptake inhibitors (SSRIs), that are a particularly common drug cause of sexual dysfunction.
- Have participated in a previous psychological intervention in the last year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Avatar-based Intervention in Second Life for Female Orgasmic Disorder: A Randomized Control Trial
A randomized controlled trial was conducted for testing the efficacy of a novel avatar-based intervention (IG), that was compared with a control group (CG) for women with female orgasmic disorder (FOD). Participants were 31 women who were randomly assigned to the intervention or the control conditions. Intervention was based on the cognitive behavioral therapy approach (treatment with the most empirical evidence) and previous literature about FOD. It consisted of 12 weekly online individual sessions and aimed at improving the FOD diagnosis, sexual variables, and variables that are known to affect orgasm consecution. Control group was based on minimum therapeutic contact. Changes over time in the assessed variables were analyzed using linear mixed models, considering treatment group, measurement time point, and group-by-time interactions as fixed effects. Effect sizes were computed (Cohen's d; number needed to treat - NNT; reliable change index - RCI).
- Conditions
- Female Orgasmic Disorder
- Being tested
- Avatar-based intervention, Individual informative talks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avatar-based interventionBehavioural
Intervention was aimed at improving sexual variables (sexual satisfaction, sexual function, and initiative and sexual communication), and variables that are known to affect orgasm consecution (sexual self-esteem, sex-guilt, and sexual anxiety). To achieve this objective, it focused on fostering participants' abilities to increase their levels of sexual stimulation, and the engagement in personal values, along with identifying and modifying dysfunctional thoughts about sexuality. The techniques used included psychosexual education, cognitive restructuring, virtual exposure, sexual stimulation, and engagement in personal values from the acceptance and commitment therapy (ACT) perspective.
It was delivered via a metaverse: Second Life.
Individual informative talksOther
Participants were provided with information about female orgasm (e.g., what is an orgasm, neuronal orgasm, factors that may influence consecution, sexual response), masturbatory techniques (e.g., key elements to achieve pleasure, anatomy of the female genitalia, pleasure areas) and techniques to focus attention on one's body (i.e., an important factor to pleasure). Participants received three individual sessions once a month, and had a duration of one hour.
| Study group | Role | What they receive |
|---|---|---|
| Avatar-based Intervention Group | Experimental | Treatment was based on the CBT approach and previous literature about FOD. It consisted of 12 weekly online individual sessions, which were administered once a week (total duration = 3 months) and lasted about 60 minutes each. Receives: Behavioral: Avatar-based intervention |
| Minimal support control group | Active comparator | It consisted in individual informative talks, during which they were provided with information about female orgasm (e.g., what is an orgasm, neuronal orgasm, factors that may influence consecution, sexual response), masturbatory techniques (e.g., key elements to achieve pleasure, anatomy of the female genitalia, pleasure areas) and techniques to focus attention on one's body (i.e., an important factor to pleasure). Participants received three individual sessions once a month, and had a duration of one hour. Receives: Other: Individual informative talks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual satisfaction assessed by the Golombok Rust Inventory of Sexual Satisfaction
Sexual satisfaction is the feeling of pleasure that one has when the sexual desire has been fulfilled.
The Golombok Rust Inventory of Sexual Satisfaction has minimum-maximum values of 0-112; higher scores mean a worse outcome. The cut-off for determining significant levels of Sexual Satisfaction is 60 (scores equal to or above 60 indicate the existence of a sexual problem).
Measured: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Sexual functionassessed by the Female Sexual Function Index
Sexual function refers to the capacity of having a satisfactory sexual life. The Female Sexual Function Index has minimum-maximum values of 19-95; higher scores mean a better outcome. The cut-off for determining significant levels of this variable is 55 (scores equal to or below 55 indicate poor Sexual Function).
Measured: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Initiative and Sexual Communication assessed by the Female Sexual Function Questionnaire
Initiative and Sexual Communication is the proactive and consensual expression of one's sexual desires, interests, and intentions within the context of a sexual relationship or encounter.
The Female Sexual Function Questionnaire has minimum-maximum values of 14-70; higher scores mean a better outcome. The cut-off for determining significantly low levels of this variable are scores equal to or lower than 25.
Measured: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Secondary outcomes (3)
Sexual self-esteem assessed by the Rosenberg Self-Esteem Scale
Self-esteem related to sexuality; may influence on the consecution of orgasms. The Rosenberg Self-Esteem Scale has minimum-maximum values of 10-40; higher scores mean a better outcome. The cut-off for clinical low self-esteem is a score equal to or lower than 25.
Measured: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Sex-guilt assessed by the Brief Mosher Sex-Guilt Scale
Sex-guilt related to sexuality; may influence on the consecution of orgasms. The Brief Mosher Sex-Guilt Scale has minimum-maximum values of 10-60; higher scores mean a worse outcome (higher scores indicate higher levels of guilt).
Measured: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Sexual anxiety by the Sexual Anxiety scale of the Expanded Sexual Arousability Inventory
Sexual anxiety related to sexualiaty; may influence on the consecution of orgasms.
TheSexual Anxiety scale of the Expanded Sexual Arousability Inventory has minimum-maximum values of 0-168; higher scores mean a worse outcome (higher scores indicate higher levels of sexual anxiety).
Measured: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Jan 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Orgasmic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ariana Vila, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187246
- Sponsor's protocol ID
- UniversidadRJC 2005202114121
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Avatar-based Intervention in Second Life for Female Orgasmic Disorder: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06187246
- Acronym / sponsor ID
- UniversidadRJC 2005202114121
- Conditions
- Female Orgasmic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial was conducted for testing the efficacy of a novel avatar-based intervention (IG), that was compared with a control group (CG) for women with female orgasmic disorder (FOD). Participants were 31 women who were randomly assigned to the intervention or the control conditions. Intervention was based on the cognitive behavioral therapy approach (treatment with the most empirical evidence) and previous literature about FOD. It consisted of 12 weekly online individual sessions and aimed at improving the FOD diagnosis, sexual variables, and variables that are known to affect orgasm consecution. Control group was based on minimum therapeutic contact. Changes over time in the assessed variables were analyzed using linear mixed models, considering treatment group, measurement time point, and group-by-time interactions as fixed effects. Effect sizes were computed (Cohen's d; number needed to treat - NNT; reliable change index - RCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Avatar-based Intervention Group | Experimental | Behavioral: Avatar-based interventionTreatment was based on the CBT approach and previous literature about FOD. It consisted of 12 weekly online individual sessions, which were administered once a week (total duration = 3 months) and lasted about 60 minutes each. |
| Minimal support control group | Active comparator | Other: Individual informative talksIt consisted in individual informative talks, during which they were provided with information about female orgasm (e.g., what is an orgasm, neuronal orgasm, factors that may influence consecution, sexual response), masturbatory techniques (e.g., key elements to achieve pleasure, anatomy of the female genitalia, pleasure areas) and techniques to focus attention on one's body (i.e., an important factor to pleasure). Participants received three individual sessions once a month, and had a duration of one hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Present the characteristics to diagnose female orgasm disorder after a clinic assessment (considering natural characteristics of the women's sexual response cycle (Conn \& Hodges, 2022) based on the DSM-5 criteria.
- Provide a medical check to prove the absence of physical factors that may be the cause of the orgasm dysfunction, as this is the first part to diagnose FOD.
- Be at least 18 years old (adult).
- Have access to a computer with the characteristics to run Second Life and internet connection.
Key exclusion criteria (5 listed)
- Present a diagnosis of a physical condition that may be the cause of the orgasm dysfunction (e.g., genital lesions, systemic and hormonal factors, vulvovaginal atrophy).
- Presence of other psychological pathology (e.g., depression, trauma) that may be the cause of the orgasm dysfunction.
- Have alcohol dependence (i.e., evaluated during the clinical assessment, according to the diagnostic criteria from the DSM-5, to determine if the individual meets the criteria for an alcohol use disorder diagnosis).
- Drug use, including medication that is known to cause sexual difficulties (e.g., selective serotonin reuptake inhibitors (SSRIs), that are a particularly common drug cause of sexual dysfunction.
- Have participated in a previous psychological intervention in the last year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avatar-based interventionIntervention was aimed at improving sexual variables (sexual satisfaction, sexual function, and initiative and sexual communication), and variables that are known to affect orgasm consecution (sexual self-esteem, sex-guilt, and sexual anxiety). To achieve this objective, it focused on fostering participants' abilities to increase their levels of sexual stimulation, and the engagement in personal values, along with identifying and modifying dysfunctional thoughts about sexuality. The techniques used included psychosexual education, cognitive restructuring, virtual exposure, sexual stimulation, and engagement in personal values from the acceptance and commitment therapy (ACT) perspective. It was delivered via a metaverse: Second Life. | Behavioural | Avatar-based Intervention Group |
| Individual informative talksParticipants were provided with information about female orgasm (e.g., what is an orgasm, neuronal orgasm, factors that may influence consecution, sexual response), masturbatory techniques (e.g., key elements to achieve pleasure, anatomy of the female genitalia, pleasure areas) and techniques to focus attention on one's body (i.e., an important factor to pleasure). Participants received three individual sessions once a month, and had a duration of one hour. | Other | Minimal support control group |
Primary outcome
Sexual satisfaction assessed by the Golombok Rust Inventory of Sexual Satisfaction
Time frame: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Sexual satisfaction is the feeling of pleasure that one has when the sexual desire has been fulfilled. The Golombok Rust Inventory of Sexual Satisfaction has minimum-maximum values of 0-112; higher scores mean a worse outcome. The cut-off for determining significant levels of Sexual Satisfaction is 60 (scores equal to or above 60 indicate the existence of a sexual problem).
Sexual functionassessed by the Female Sexual Function Index
Time frame: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Sexual function refers to the capacity of having a satisfactory sexual life. The Female Sexual Function Index has minimum-maximum values of 19-95; higher scores mean a better outcome. The cut-off for determining significant levels of this variable is 55 (scores equal to or below 55 indicate poor Sexual Function).
Initiative and Sexual Communication assessed by the Female Sexual Function Questionnaire
Time frame: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Initiative and Sexual Communication is the proactive and consensual expression of one's sexual desires, interests, and intentions within the context of a sexual relationship or encounter. The Female Sexual Function Questionnaire has minimum-maximum values of 14-70; higher scores mean a better outcome. The cut-off for determining significantly low levels of this variable are scores equal to or lower than 25.
3 secondary outcomes
Sexual self-esteem assessed by the Rosenberg Self-Esteem Scale
Time frame: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Sex-guilt assessed by the Brief Mosher Sex-Guilt Scale
Time frame: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Sexual anxiety by the Sexual Anxiety scale of the Expanded Sexual Arousability Inventory
Time frame: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Female Orgasmic Disorder
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
RecruitingObservational study
The PANHIS Study: Sexual Health in Spanish-Speaking Adults - A Cross-Sectional Online Survey
Sexual Health, Sexual Dysfunction, Physiological
Enrolling by invitation
Effect of Two Cognitive-Behavioral Interventions on Cervical Cancer Patients
Cervical Cancer, Psychological Distress
Not yet recruitingPhase 2
Study of S1B-408 in Women With Orgasmic Dysfunction
Orgasmic Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avatar-based intervention and Individual informative talks in people with Female Orgasmic Disorder, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual satisfaction assessed by the Golombok Rust Inventory of Sexual Satisfaction (time frame: From baseline to the end of the treatment at 12 weeks + 1 month-follow-up and 3 month-follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.