Sexual Desire DisorderNCT03720743
Effect of Biodanza on Desire, Excitation and Sexual Inhibition
A study testing Biodanza in people with Sexual Desire Disorder and Sexual Arousal Disorder, run by Universidad de Almeria at 1 site in Spain.
Trial summary
the objective of this study was to examine the effects of a 10 weeks biodanza program on the sexual desire and inhibition/arousal of a sample of healthy young adults. A randomized clinical study was carried out, involving a total of 86 young adults divided into Intervention Group (BG) and Control Group (CG), carrying… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Desire Disorder, Sexual Arousal Disorder, Sexual Inhibition
- What is being tested?
- Biodanza
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2018to 1 Jun 2018
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 18 years old
- having correctly completed the online questionnaire.
- to attend a minimum of eight Biodanza sessions.
Who cannot join
- exceed 30 years old.
- the presence of some type of physical or mental disability that could prevent their participation in the therapy or the completion of the questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Biodanza Program on Desire, Excitation and Sexual Inhibition in Young Adults. A Randomized Pilot Study
the objective of this study was to examine the effects of a 10 weeks biodanza program on the sexual desire and inhibition/arousal of a sample of healthy young adults.
A randomized clinical study was carried out, involving a total of 86 young adults divided into Intervention Group (BG) and Control Group (CG), carrying out biodanza sessions during 10 weeks. The Sexual Desire Inventory (SDI) and the Sexual Inhibition/Sexual Arousal-Short Form Scale (SIS/SES-SF) were completed before and after the intervention.
- Being tested
- Biodanza
- Keywords
- Biodanza, libido, sexual excitement, sexual inhibition, young adults, dance therapy, complementary therapies
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodanzaOther
Also called Dance
Intervention group received a total of 10 sessions, once a week, over the course of two months. Each session lasted 60 minutes. All sessions began with a 10-minute warm-up period combining music and low-intensity movements as a welcome round, followed individual exercises, in pairs and/or groups, which included dance combined with exercises based on the five lines of Biodanza (vitality, sexuality, creativity, affectivity and transcendence). Finally, a celebration and farewell round of 10 minutes was held. At the end of each session, the participants were asked to share their experiences with the rest of the group.
| Study group | Role | What they receive |
|---|---|---|
| Biodanza | Experimental | Intervention group received a total of 10 sessions, once a week, over the course of two months. Each session lasted 60 minutes. All sessions began with a 10-minute warm-up period combining music and low-intensity movements as a welcome round, followed individual exercises, in pairs and/or groups, which included dance combined with exercises based on the five lines of Biodanza (vitality, sexuality, creativity, affectivity and transcendence). Finally, a celebration and farewell round of 10 minutes was held. At the end of each session, the participants were asked to share their experiences with the rest of the group. Receives: Other: Biodanza |
| Control Group | No intervention | The study allowed control group subjects to participate in Biodanza sessions after the follow-up period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual desire
Sexual Desire Inventory (SDI) formed by 13 items, divided into dyadic sexual desire (Dyadic SD) (items 1-9) and solitary sexual desire (Solitary SD) (items 10-13), and valued by a Likert scale according to frequency (0 = never, and 7 = more than once a day), and intensity (0 = not desire, and 8 = strong desire), in a total range between 0 and 101 points, being higher the desire the greater the response result.
Measured: 3 months
Sexual excitement/sexual inhibition
Sexual Inhibition/Sexual Excitement Scales - Short Form consists of 14 items with responses assessed using a Likert scale 1-4 (1 = completely agree; 4 = completely disagree) that measure three sub-scales: Sexual Excitation Scale (SES) (items 1, 3, 8, 10, 11, 14) with a score range between 4 and 16; Sexual Inhibition Scale 1 (SIS1) (items 4, 9, 12, 13) related to distraction/concentration in sexual performance, with a range between 4 and 16, and Sexual Inhibition Scale 2 (SIS2) (items 2, 5, 6, 7) related to the fear to be discovered or to contract some type of sexually transmitted infection (STI), with a range between 4 and 16.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start15 Jan 2018
- Primary completion1 Mar 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Desire 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
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María del Mar Lopez-Rodriguez, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720743
- Sponsor's protocol ID
- amuelle
- Status last verified
- Oct 2018
- First submitted
- 24 Oct 2018
- Last updated
- 29 Oct 2018
- 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 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Biodanza Program on Desire, Excitation and Sexual Inhibition in Young Adults. A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03720743
- Acronym / sponsor ID
- amuelle
- Keywords
- Biodanza, libido, sexual excitement, sexual inhibition, young adults, dance therapy, complementary therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 25 Oct 2018 (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.
the objective of this study was to examine the effects of a 10 weeks biodanza program on the sexual desire and inhibition/arousal of a sample of healthy young adults.
A randomized clinical study was carried out, involving a total of 86 young adults divided into Intervention Group (BG) and Control Group (CG), carrying out biodanza sessions during 10 weeks. The Sexual Desire Inventory (SDI) and the Sexual Inhibition/Sexual Arousal-Short Form Scale (SIS/SES-SF) were completed before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodanza | Experimental | Other: BiodanzaIntervention group received a total of 10 sessions, once a week, over the course of two months. Each session lasted 60 minutes. All sessions began with a 10-minute warm-up period combining music and low-intensity movements as a welcome round, followed individual exercises, in pairs and/or groups, which included dance combined with exercises based on the five lines of Biodanza (vitality, sexuality, creativity, affectivity and transcendence). Finally, a celebration and farewell round of 10 minutes was held. At the end of each session, the participants were asked to share their experiences with the rest of the group. |
| Control Group | No intervention | –The study allowed control group subjects to participate in Biodanza sessions after the follow-up period. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- at least 18 years old
- having correctly completed the online questionnaire.
- to attend a minimum of eight Biodanza sessions.
Key exclusion criteria (2 listed)
- exceed 30 years old.
- the presence of some type of physical or mental disability that could prevent their participation in the therapy or the completion of the questionnaires.
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 |
|---|---|---|
| BiodanzaAlso: DanceIntervention group received a total of 10 sessions, once a week, over the course of two months. Each session lasted 60 minutes. All sessions began with a 10-minute warm-up period combining music and low-intensity movements as a welcome round, followed individual exercises, in pairs and/or groups, which included dance combined with exercises based on the five lines of Biodanza (vitality, sexuality, creativity, affectivity and transcendence). Finally, a celebration and farewell round of 10 minutes was held. At the end of each session, the participants were asked to share their experiences with the rest of the group. | Other | Biodanza |
Primary outcome
Sexual desire
Time frame: 3 months
Sexual Desire Inventory (SDI) formed by 13 items, divided into dyadic sexual desire (Dyadic SD) (items 1-9) and solitary sexual desire (Solitary SD) (items 10-13), and valued by a Likert scale according to frequency (0 = never, and 7 = more than once a day), and intensity (0 = not desire, and 8 = strong desire), in a total range between 0 and 101 points, being higher the desire the greater the response result.
Sexual excitement/sexual inhibition
Time frame: 3 months
Sexual Inhibition/Sexual Excitement Scales - Short Form consists of 14 items with responses assessed using a Likert scale 1-4 (1 = completely agree; 4 = completely disagree) that measure three sub-scales: Sexual Excitation Scale (SES) (items 1, 3, 8, 10, 11, 14) with a score range between 4 and 16; Sexual Inhibition Scale 1 (SIS1) (items 4, 9, 12, 13) related to distraction/concentration in sexual performance, with a range between 4 and 16, and Sexual Inhibition Scale 2 (SIS2) (items 2, 5, 6, 7) related to the fear to be discovered or to contract some type of sexually transmitted infection (STI), with a range between 4 and 16.
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 29 Oct 2018.
- Individual participant dataSharing planned: No
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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 Biodanza in people with Sexual Desire Disorder and Sexual Arousal Disorder, run by Universidad de Almeria 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 3 inclusion and 2 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 29 Oct 2018. 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 desire (time frame: 3 months). The study lists 2 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 29 Oct 2018.