Sexual HealthPANHISNCT07746297
The PANHIS Study: Sexual Health in Spanish-Speaking Adults - A Cross-Sectional Online Survey
An observational study of Sexual Health and Sexual Dysfunction, Physiological, run by Menoclinica by Palacios at 2 sites in Spain.
Trial summary
This cross-sectional observational study uses an online survey to describe the epidemiology of sexual health, sexual behaviour and sexual function in Spanish-speaking adults, and to estimate the prevalence and phenomenology of expanded (altered) states of consciousness associated with orgasm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexual Health, Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological
- How many people
- 15,000 participants
- Where
- 2 sitesSpain
- Study dates
- 30 Aug 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Spanish-speaking adults aged 18 years or older with internet access, recruited online through social media. Convenience sample, not intended to be nationally representative; post-stratification weighting is applied and selection bias is addressed in sensitivity analyses.
Who may be able to join
- Age ≥ 18 years (self-reported)
- Sufficient command of Spanish to understand and respond to the questionnaire
- Internet access and a device compatible with the digital survey form
- Explicit informed consent provided digitally before accessing the questionnaire
Who cannot join
- Refusal of informed consent
- Questionnaire completion rate below 70% (the threshold also required to access the participation incentive)
- Duplicate response, identified by exact email match (when provided) or by analysis of response patterns and technical fingerprint (timestamp, IP address, user agent)
- Implausible response patterns (e.g., age of sexual debut greater than current age, systematic straight-lining on reverse-coded scales, completion times below the first percentile of the pilot) - Aged under 18
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Not yet recruiting
Menoclínica S.L. (Collaborating Center for Online Study)
Madrid, Madrid, 28009
Silvia P Menoclínica, MD, PhD, MSc, +34 914 324 499, menoclinica@menoclinica.com
Menoclínica Research Office, +34 914 324 499, menoclinica@menoclinica.com
- Recruiting
Universidad Europea del Atlántico - Cátedra de Sexología y Salud (Coordinating Center for Online Study)
Santander, Cantabria, 39011
Silvia P González Rodríguez, MD, PhD, MSc, +34621192307, silviapgonzalez@menoclinica.com
Menoclínica Research Office, +34 914 324 499, menoclinica@menoclinica.com
About this study
Official title: PANHIS - Pan-Hispanic Adult Sexual Health International Study: a Cross-sectional Online Study of Sexual Health, Sexual Behaviour and Expanded States of Consciousness Associated With Orgasm in Spanish-speaking Adults
This cross-sectional observational study uses an online survey to describe the epidemiology of sexual health, sexual behaviour and sexual function in Spanish-speaking adults, and to estimate the prevalence and phenomenology of expanded (altered) states of consciousness associated with orgasm. The study has two prespecified aims, analysed and reported as two separate manuscripts:
- sexual health and behaviour epidemiology and associated factors; and
- expanded states of consciousness associated with orgasm. Recruitment is via social media with complementary channels. Sexual function is assessed with a brief study-developed instrument administered identically to all participants, enabling direct between-sex comparison. Survey weights are applied. Reporting follows STROBE and CHERRIES.
Read the detailed description
Background and rationale Sexual health is recognised by the World Health Organization (2006) as a state of physical, emotional, mental, and social well-being in relation to sexuality, beyond the absence of disease. Large-scale epidemiological surveys such as the National Survey of Sexual Attitudes and Lifestyles (Natsal) in the United Kingdom and the National Health and Social Life Survey (NHSLS) in the United States have provided fundamental evidence informing public health policy. No equivalent study currently exists for the Spanish-speaking world covering sexual health cross-nationally.
In addition, an emerging body of neuroscience literature has documented activation of brain networks compatible with trance and mystical experiences during orgasm (Komisaruk et al., 2004; Safron, 2016). The prevalence, associated factors, and subjective impact of such expanded states of consciousness in the general Spanish-speaking population have not been systematically studied.
Study design This is a multi-country, cross-sectional, observational, descriptive study. Data are collected through a single online questionnaire administered via a custom web application. Submissions are transmitted to a Google Form, which writes them automatically to a linked, EU-hosted spreadsheet; this architecture was chosen because it withstands high-concurrency traffic spikes following social media posts without silent loss of responses, which a direct-write backend would not reliably withstand. Data are processed in compliance with the GDPR. Participation is anonymous for participants who do not provide an email address, and pseudonymised for those who choose to provide one, which is used only for assistance with the study incentive and, subject to a separate and independent consent, for recontact regarding future studies.
Population and recruitment The target population comprises adults (≥18 years) who are Spanish-speaking and have internet access. Sampling is non-probabilistic, by convenience, primarily through the Instagram account @mamacasquet (~2.5 million followers) with a video introduction and a direct link to the survey. Complementary recruitment is conducted via Facebook, X, allied social media accounts, and professional sexology associations to diversify the sample by age and country.
Eligibility for participation is detailed under Eligibility Criteria. In addition to those criteria, the following data-quality rules are applied at analysis: completion rate below 70% of the questionnaire, which is enforced by the survey platform itself and prevents submission; duplicate responses (detected by exact email match where provided, or by response pattern and technical fingerprint); and implausible response patterns (for example, age of sexual debut greater than current age, systematic straight-lining on reverse-coded items, or completion time below the first percentile of the pilot distribution). Except for the 70% threshold, records failing these checks are retained in the dataset and flagged for sensitivity analysis rather than excluded outright.
Sample size justification To estimate prevalences in the general population, assuming the most conservative scenario (p = 0.5), 95% confidence level, and ±1.4 percentage point margin of error, the minimum sample size required is approximately 5,000 complete responses. For country-stratified analyses (assuming 8-10 countries with sufficient representation and prevalences around 30%), 500 responses per stratum yield precision of ±4 percentage points. For multivariable logistic regression models with 15-20 predictors, applying the rule of thumb of 10-20 events per variable (Peduzzi et al., 1996), the minimum sample size is comfortably met assuming event prevalences ≥ 5%. Given the audience of the principal collaborator (~2.5 million followers) and expected response rates of 0.5-1%, the anticipated final sample size is 15,000 to 30,000 complete responses.
Measures Sexual function and satisfaction are assessed with a brief instrument developed by the research team (the PANHIS Sexual Function Index, PSFI): 11 items administered identically to all participants, with a common 4-week recall period and a common 0-4 response scale, covering frequency of sexual activity, desire, subjective arousal, genital physical response, orgasm, pain during receptive penetration, sexual satisfaction, associated distress, global self-rated sexual function, sexual self-esteem, and communication with partner(s).
Rationale for a study-developed instrument. The protocol originally approved by the Research Ethics Committee specified the Female Sexual Function Index short version (FSFI-6) for participants with female sexual response and the International Index of Erectile Function (IIEF-5) for participants with male sexual response. Licence applications for academic use of both instruments, submitted through Mapi Research Trust, received no response and no timeframe could be established; this change was notified to the Committee before data collection began. Beyond availability, administering different instruments to men and women confounds between-sex differences with differences between the instruments themselves, since the FSFI-6 and IIEF-5 differ in recall period, item count, domain structure and cut-off calibration. An identical item set with an identical recall period and response scale permits direct and interpretable between-sex comparison. In addition, the PSFI treats absence of sexual activity during the recall period as not applicable rather than as a zero score, avoiding the overestimation artefact documented for instruments that assign null scores to sexual inactivity.
The phenomenological module on expanded states of consciousness during orgasm is conceptually informed by domains described in the Mystical Experience Questionnaire (MEQ-30; MacLean et al., 2012) and in the broader literature on non-ordinary states of consciousness, but does not constitute a formal application of the MEQ-30 or of any other standardised instrument; these items are of original wording and are prespecified as exploratory. The remaining items (sociodemographics, general health, sexual behaviour, education, psychosocial factors) are ad hoc and were developed by the research team.
Data quality is additionally supported by two embedded attention/validity items, distributed at separated points in the questionnaire, and by age verification enforced at three points in the questionnaire flow. Participants failing the attention items are retained in the dataset and flagged for sensitivity analysis rather than excluded.
Measurement properties of the study-developed index will also be examined in this sample, including internal consistency, dimensionality (exploratory factor analysis in a randomly selected half of the sample and confirmatory factor analysis in the other half, with a fixed random seed recorded in the analysis code), convergent validity against a global self-rated anchor item, floor and ceiling effects, and measurement invariance across sex, age group and country where sample size permits. These analyses provide preliminary psychometric evidence and do not constitute a complete validation study: the cross-sectional design precludes assessment of test-retest reliability and responsiveness, and no criterion measure is administered.
Statistical analysis plan Descriptive analyses (frequencies, means, medians, standard deviations). Bivariate analyses (chi-square, t-tests, ANOVA, Spearman correlations). Multivariable logistic regression for factors associated with self-reported sexual difficulty with associated distress and with expanded states of consciousness, adjusting for prespecified confounders (age, sex recorded at birth, sexual identity, sexual orientation, country, education level, relationship status, physical and mental health comorbidities, alcohol and substance use). Post-stratification weighting by age and sex according to national census data. The false discovery rate is controlled using the Benjamini-Hochberg procedure within each axis's hypothesis family. Sensitivity analyses assess the impact of selection bias, weighting, attention-item failure, and completion-time outliers. Quantitative variables are analysed both as continuous and as categorised according to prespecified cut-offs. Missing data: complete-case analysis as primary; multiple imputation by chained equations (MICE, 20 imputations, Rubin's rules) as sensitivity analysis if missingness exceeds 5% on key variables, except for "not applicable" responses (for example, absence of sexual activity), which are never imputed. Software: R (v4.x) and/or SPSS (v28+).
Reporting and data sharing The study will be reported in accordance with the STROBE guidelines (von Elm et al., 2007) for cross-sectional observational studies and the CHERRIES guidelines for internet-based surveys. After publication of the main manuscript, anonymised data (without the email column) and analysis code will be deposited in a public repository (Zenodo or equivalent) under an open licence, subject to data protection requirements.
- Conditions
- Sexual Health, Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Dyspareunia, Orgasm, Sexual Behavior
- Keywords
- sexual health, Spanish-speaking populations, Hispanic / Latino, epidemiology, online survey, expanded states of consciousness, orgasm, cross-sectional study, sexual function, cross-cultural comparison, patient-reported outcome
- Medical subject headings
- Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Dyspareunia, Orgasm, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Adult Spanish-speaking individuals (≥18 years) recruited online via social media (primarily Instagram, complemented by Facebook, X, and professional sexology associations) who provide explicit informed consent and complete the cross-sectional online survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with self-reported sexual difficulty with associated distress
Percentage of participants meeting the prespecified definition of self-reported sexual difficulty with associated distress, assessed using the PANHIS Sexual Function Index (PSFI), a study-developed 11-item self-report questionnaire. Participants meet the definition when they score 0 or 1 on at least one of the five PSFI function domains (desire, subjective arousal, genital physical response, orgasm, and pain during receptive penetration; each domain scored 0 to 4, where higher scores indicate better sexual function) and simultaneously score 2 or 3 on the PSFI associated-distress item (scored 0 to 3, where higher scores indicate greater distress). Responses of "not applicable" are treated as not applicable and are not scored as zero. PSFI items refer to the 4 weeks preceding survey completion. Reported as a weighted percentage of participants. This outcome is reported as self-reported sexual difficulty with associated distress and does not constitute a diagnosis of sexual dysfunction.
Measured: Baseline
Percentage of participants reporting expanded states of consciousness associated with orgasm
Percentage of participants reporting expanded or altered states of consciousness associated with orgasm, identified by a single study-developed screening item asking whether they have ever experienced, during a sexual experience, changes in bodily perception or intense or unusual sensations. The item has three response options: yes; not sure; no. The primary estimate is the percentage answering "yes". The combined percentage answering "yes" or "not sure" is reported alongside it as a prespecified upper-bound estimate. Both the "yes" and the "not sure" groups are shown the characterisation module and are described separately. Lifetime recall. Unit of measure: percentage of participants.
Measured: Baseline
Secondary outcomes (12)
PANHIS Sexual Function Index (PSFI) total score
Mean total score on the PANHIS Sexual Function Index (PSFI), a study-developed self-report instrument. The total score is the sum of five function domains (desire, subjective arousal, genital physical response, orgasm, and pain during receptive penetration), each scored 0 to 4. Total score range 0 to 20, where higher scores indicate better sexual function. Computed only for participants with at least 4 of the 5 domains applicable, using prorating. Items refer to the 4 weeks preceding survey completion. Reported overall and by sex recorded at birth, sexual identity and country. Unit of measure: units on a scale.
Measured: Baseline
Sexual satisfaction score
Mean score on a single study-developed item asking participants to rate their satisfaction with their sex life over the preceding 4 weeks on an 11-point numeric rating scale from 0 to 10, where 0 indicates completely dissatisfied and 10 indicates completely satisfied. Higher scores indicate a better outcome. Unit of measure: units on a scale.
Measured: Baseline
Sexual self-esteem score
Mean score on a single study-developed item asking participants to rate their sexual self-esteem on an 11-point numeric rating scale from 0 to 10, where 0 indicates very negative and 10 indicates very positive. Higher scores indicate a better outcome. Unit of measure: units on a scale.
Measured: Baseline
Percentage of participants in each category of formal sexual education received
Percentage of participants in each response category of a single study-developed item on formal sexual education received, with four ordered categories (none; yes, very basic; yes, fairly complete; yes, very complete). Reported overall and by country. Unit of measure: percentage of participants.
Measured: Baseline
Percentage of participants reporting each category of expanded state of consciousness
Among participants reporting expanded states of consciousness associated with orgasm, percentage endorsing each of seven prespecified categories presented as a study-developed multiple-response item, each accompanied by illustrative examples: losing track of time or of one's surroundings; entering a state of trance or deep absorption; changes in the perception of one's body; waves, vibrations, currents or intense involuntary bodily movements; a sense of very deep connection or unity; a momentary change in or disappearance of the sense of self; and perceiving things differently or especially vividly. A free-text "other" option is also provided. Lifetime recall. Unit of measure: percentage of participants.
Measured: Baseline
Percentage of participants in each frequency category of expanded states of consciousness
Among participants reporting expanded states of consciousness associated with orgasm, percentage in each response category of a single study-developed item on frequency of occurrence, with five ordered categories (only once; very rarely; occasionally; frequently; almost always). Lifetime recall. Unit of measure: percentage of participants.
Measured: Baseline
Percentage of participants reporting each context of occurrence of expanded states of consciousness
Among participants reporting expanded states of consciousness associated with orgasm, percentage endorsing each prespecified context of occurrence presented as a study-developed multiple-response item: masturbation; with a regular partner; with new partners; following substance use; during tantric or breathing practices; in BDSM contexts; and no clear pattern. Lifetime recall. Unit of measure: percentage of participants.
Measured: Baseline
Subjective intensity of expanded states of consciousness
Among participants reporting expanded states of consciousness associated with orgasm, mean score on a single study-developed item rating the subjective intensity of those experiences on a 10-point numeric rating scale from 1 to 10, where 1 indicates very mild and 10 indicates transformative. Higher scores indicate greater intensity. Unit of measure: units on a scale.
Measured: Baseline
Self-reported impact of expanded states of consciousness on emotional or spiritual well-being
Among participants reporting expanded states of consciousness associated with orgasm, mean score on a single study-developed item rating the impact of those experiences on emotional or spiritual well-being, on an 11-point numeric rating scale from -5 to +5, where -5 indicates a very negative impact, 0 indicates no impact and +5 indicates a very positive impact. Higher scores indicate a more positive impact. Unit of measure: units on a scale.
Measured: Baseline
Age at first sexual intercourse
Mean self-reported age, in years, at which participants first had sexual intercourse with another person. Participants who have not had sexual intercourse are recorded as not applicable and excluded from this outcome. Unit of measure: years.
Measured: Baseline
Number of sexual partners in the preceding 12 months
Mean self-reported number of people with whom participants had sexual relations during the 12 months preceding survey completion. Unit of measure: number of partners.
Measured: Baseline
Percentage of participants reporting a previous sexually transmitted infection
Percentage of participants reporting one or more previous sexually transmitted infections, from a study-developed multiple-response item listing human papillomavirus, chlamydia, gonorrhoea, syphilis, genital herpes and human immunodeficiency virus, together with options for none, other, and do not know. Lifetime recall. Unit of measure: percentage of participants.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start30 Aug 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sexual HealthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoclinica by Palacios
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Europea del Atlántico
- Responsible party
- Sponsor
- Investigators
- Silvia P. González Rodríguez, MD, PhD, MSc, Principal investigator, Universidad Europea del Atlántico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746297
- Sponsor's protocol ID
- PANHIS-2026-001
- Other IDs
- PANHIS-2026-001, 10.17605/OSF.IO/56BZE
- Acronym
- PANHIS
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant-level data will be made publicly available following publication of the primary results. The dataset will include all variables collected through the online questionnaire, excluding directly identifying information: the email address column, which is optional and used only for assistance with the study incentive and, subject to a separate and independent consent, for recontact regarding future studies, will be removed entirely. The full codebook and the analysis code (R and/or SPSS syntax) will be shared alongside the dataset, via a public repository, to enable replication.
Publications
von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008.
PubMed 18313558von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
PubMed 18064739Mitchell KR, Mercer CH, Ploubidis GB, Jones KG, Datta J, Field N, Copas AJ, Tanton C, Erens B, Sonnenberg P, Clifton S, Macdowall W, Phelps A, Johnson AM, Wellings K. Sexual function in Britain: findings from the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3). Lancet. 2013 Nov 30;382(9907):1817-29. doi: 10.1016/S0140-6736(13)62366-1. Epub 2013 Nov 26.
PubMed 24286787Safron A. What is orgasm? A model of sexual trance and climax via rhythmic entrainment. Socioaffect Neurosci Psychol. 2016 Oct 25;6:31763. doi: 10.3402/snp.v6.31763. eCollection 2016.
PubMed 27799079Maclean KA, Leoutsakos JM, Johnson MW, Griffiths RR. Factor Analysis of the Mystical Experience Questionnaire: A Study of Experiences Occasioned by the Hallucinogen Psilocybin. J Sci Study Relig. 2012 Dec;51(4):721-737. doi: 10.1111/j.1468-5906.2012.01685.x.
PubMed 23316089Komisaruk BR, Whipple B, Crawford A, Liu WC, Kalnin A, Mosier K. Brain activation during vaginocervical self-stimulation and orgasm in women with complete spinal cord injury: fMRI evidence of mediation by the vagus nerves. Brain Res. 2004 Oct 22;1024(1-2):77-88. doi: 10.1016/j.brainres.2004.07.029.
PubMed 15451368Perez-Lopez FR, Fernandez-Alonso AM, Trabalon-Pastor M, Vara C, Chedraui P; MenopAuse RIsk Assessment (MARIA) Research Group. Assessment of sexual function and related factors in mid-aged sexually active Spanish women with the six-item Female Sex Function Index. Menopause. 2012 Nov;19(11):1224-30. doi: 10.1097/gme.0b013e3182546242.
PubMed 22781787
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PANHIS - Pan-Hispanic Adult Sexual Health International Study: a Cross-sectional Online Study of Sexual Health, Sexual Behaviour and Expanded States of Consciousness Associated With Orgasm in Spanish-speaking Adults
- ClinicalTrials.gov ID
- NCT07746297
- Acronym / sponsor ID
- PANHIS / PANHIS-2026-001
- Conditions
- Sexual Health, Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Dyspareunia, Orgasm, Sexual Behavior
- Keywords
- sexual health, Spanish-speaking populations, Hispanic / Latino, epidemiology, online survey, expanded states of consciousness, orgasm, cross-sectional study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Menoclinica by PalaciosUniversity, hospital or other
- Collaborators
- Universidad Europea del Atlántico
- Study start
- 30 Aug 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Aug 2026 (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.
This cross-sectional observational study uses an online survey to describe the epidemiology of sexual health, sexual behaviour and sexual function in Spanish-speaking adults, and to estimate the prevalence and phenomenology of expanded (altered) states of consciousness associated with orgasm. The study has two prespecified aims, analysed and reported as two separate manuscripts:
- sexual health and behaviour epidemiology and associated factors; and
- expanded states of consciousness associated with orgasm. Recruitment is via social media with complementary channels. Sexual function is assessed with a brief study-developed instrument administered identically to all participants, enabling direct between-sex comparison. Survey weights are applied. Reporting follows STROBE and CHERRIES.
Detailed description
Background and rationale Sexual health is recognised by the World Health Organization (2006) as a state of physical, emotional, mental, and social well-being in relation to sexuality, beyond the absence of disease. Large-scale epidemiological surveys such as the National Survey of Sexual Attitudes and Lifestyles (Natsal) in the United Kingdom and the National Health and Social Life Survey (NHSLS) in the United States have provided fundamental evidence informing public health policy. No equivalent study currently exists for the Spanish-speaking world covering sexual health cross-nationally.
In addition, an emerging body of neuroscience literature has documented activation of brain networks compatible with trance and mystical experiences during orgasm (Komisaruk et al., 2004; Safron, 2016). The prevalence, associated factors, and subjective impact of such expanded states of consciousness in the general Spanish-speaking population have not been systematically studied.
Study design This is a multi-country, cross-sectional, observational, descriptive study. Data are collected through a single online questionnaire administered via a custom web application. Submissions are transmitted to a Google Form, which writes them automatically to a linked, EU-hosted spreadsheet; this architecture was chosen because it withstands high-concurrency traffic spikes following social media posts without silent loss of responses, which a direct-write backend would not reliably withstand. Data are processed in compliance with the GDPR. Participation is anonymous for participants who do not provide an email address, and pseudonymised for those who choose to provide one, which is used only for assistance with the study incentive and, subject to a separate and independent consent, for recontact regarding future studies.
Population and recruitment The target population comprises adults (≥18 years) who are Spanish-speaking and have internet access. Sampling is non-probabilistic, by convenience, primarily through the Instagram account @mamacasquet (~2.5 million followers) with a video introduction and a direct link to the survey. Complementary recruitment is conducted via Facebook, X, allied social media accounts, and professional sexology associations to diversify the sample by age and country.
Eligibility for participation is detailed under Eligibility Criteria. In addition to those criteria, the following data-quality rules are applied at analysis: completion rate below 70% of the questionnaire, which is enforced by the survey platform itself and prevents submission; duplicate responses (detected by exact email match where provided, or by response pattern and technical fingerprint); and implausible response patterns (for example, age of sexual debut greater than current age, systematic straight-lining on reverse-coded items, or completion time below the first percentile of the pilot distribution). Except for the 70% threshold, records failing these checks are retained in the dataset and flagged for sensitivity analysis rather than excluded outright.
Sample size justification To estimate prevalences in the general population, assuming the most conservative scenario (p = 0.5), 95% confidence level, and ±1.4 percentage point margin of error, the minimum sample size required is approximately 5,000 complete responses. For country-stratified analyses (assuming 8-10 countries with sufficient representation and prevalences around 30%), 500 responses per stratum yield precision of ±4 percentage points. For multivariable logistic regression models with 15-20 predictors, applying the rule of thumb of 10-20 events per variable (Peduzzi et al., 1996), the minimum sample size is comfortably met assuming event prevalences ≥ 5%. Given the audience of the principal collaborator (~2.5 million followers) and expected response rates of 0.5-1%, the anticipated final sample size is 15,000 to 30,000 complete responses.
Measures Sexual function and satisfaction are assessed with a brief instrument developed by the research team (the PANHIS Sexual Function Index, PSFI): 11 items administered identically to all participants, with a common 4-week recall period and a common 0-4 response scale, covering frequency of sexual activity, desire, subjective arousal, genital physical response, orgasm, pain during receptive penetration, sexual satisfaction, associated distress, global self-rated sexual function, sexual self-esteem, and communication with partner(s).
Rationale for a study-developed instrument. The protocol originally approved by the Research Ethics Committee specified the Female Sexual Function Index short version (FSFI-6) for participants with female sexual response and the International Index of Erectile Function (IIEF-5) for participants with male sexual response. Licence applications for academic use of both instruments, submitted through Mapi Research Trust, received no response and no timeframe could be established; this change was notified to the Committee before data collection began. Beyond availability, administering different instruments to men and women confounds between-sex differences with differences between the instruments themselves, since the FSFI-6 and IIEF-5 differ in recall period, item count, domain structure and cut-off calibration. An identical item set with an identical recall period and response scale permits direct and interpretable between-sex comparison. In addition, the PSFI treats absence of sexual activity during the recall period as not applicable rather than as a zero score, avoiding the overestimation artefact documented for instruments that assign null scores to sexual inactivity.
The phenomenological module on expanded states of consciousness during orgasm is conceptually informed by domains described in the Mystical Experience Questionnaire (MEQ-30; MacLean et al., 2012) and in the broader literature on non-ordinary states of consciousness, but does not constitute a formal application of the MEQ-30 or of any other standardised instrument; these items are of original wording and are prespecified as exploratory. The remaining items (sociodemographics, general health, sexual behaviour, education, psychosocial factors) are ad hoc and were developed by the research team.
Data quality is additionally supported by two embedded attention/validity items, distributed at separated points in the questionnaire, and by age verification enforced at three points in the questionnaire flow. Participants failing the attention items are retained in the dataset and flagged for sensitivity analysis rather than excluded.
Measurement properties of the study-developed index will also be examined in this sample, including internal consistency, dimensionality (exploratory factor analysis in a randomly selected half of the sample and confirmatory factor analysis in the other half, with a fixed random seed recorded in the analysis code), convergent validity against a global self-rated anchor item, floor and ceiling effects, and measurement invariance across sex, age group and country where sample size permits. These analyses provide preliminary psychometric evidence and do not constitute a complete validation study: the cross-sectional design precludes assessment of test-retest reliability and responsiveness, and no criterion measure is administered.
Statistical analysis plan Descriptive analyses (frequencies, means, medians, standard deviations). Bivariate analyses (chi-square, t-tests, ANOVA, Spearman correlations). Multivariable logistic regression for factors associated with self-reported sexual difficulty with associated distress and with expanded states of consciousness, adjusting for prespecified confounders (age, sex recorded at birth, sexual identity, sexual orientation, country, education level, relationship status, physical and mental health comorbidities, alcohol and substance use). Post-stratification weighting by age and sex according to national census data. The false discovery rate is controlled using the Benjamini-Hochberg procedure within each axis's hypothesis family. Sensitivity analyses assess the impact of selection bias, weighting, attention-item failure, and completion-time outliers. Quantitative variables are analysed both as continuous and as categorised according to prespecified cut-offs. Missing data: complete-case analysis as primary; multiple imputation by chained equations (MICE, 20 imputations, Rubin's rules) as sensitivity analysis if missingness exceeds 5% on key variables, except for "not applicable" responses (for example, absence of sexual activity), which are never imputed. Software: R (v4.x) and/or SPSS (v28+).
Reporting and data sharing The study will be reported in accordance with the STROBE guidelines (von Elm et al., 2007) for cross-sectional observational studies and the CHERRIES guidelines for internet-based surveys. After publication of the main manuscript, anonymised data (without the email column) and analysis code will be deposited in a public repository (Zenodo or equivalent) under an open licence, subject to data protection requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | –Adult Spanish-speaking individuals (≥18 years) recruited online via social media (primarily Instagram, complemented by Facebook, X, and professional sexology associations) who provide explicit informed consent and complete the cross-sectional online survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Spanish-speaking adults aged 18 years or older with internet access, recruited online through social media. Convenience sample, not intended to be nationally representative; post-stratification weighting is applied and selection bias is addressed in sensitivity analyses.
Key inclusion criteria (4 listed)
- Age ≥ 18 years (self-reported)
- Sufficient command of Spanish to understand and respond to the questionnaire
- Internet access and a device compatible with the digital survey form
- Explicit informed consent provided digitally before accessing the questionnaire
Key exclusion criteria (4 listed)
- Refusal of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants with self-reported sexual difficulty with associated distress
Time frame: Baseline
Percentage of participants meeting the prespecified definition of self-reported sexual difficulty with associated distress, assessed using the PANHIS Sexual Function Index (PSFI), a study-developed 11-item self-report questionnaire. Participants meet the definition when they score 0 or 1 on at least one of the five PSFI function domains (desire, subjective arousal, genital physical response, orgasm, and pain during receptive penetration; each domain scored 0 to 4, where higher scores indicate better sexual function) and simultaneously score 2 or 3 on the PSFI associated-distress item (scored 0 to 3, where higher scores indicate greater distress). Responses of "not applicable" are treated as not applicable and are not scored as zero. PSFI items refer to the 4 weeks preceding survey completion. Reported as a weighted percentage of participants. This outcome is reported as self-reported sexual difficulty with associated distress and does not constitute a diagnosis of sexual dysfunction.
Percentage of participants reporting expanded states of consciousness associated with orgasm
Time frame: Baseline
Percentage of participants reporting expanded or altered states of consciousness associated with orgasm, identified by a single study-developed screening item asking whether they have ever experienced, during a sexual experience, changes in bodily perception or intense or unusual sensations. The item has three response options: yes; not sure; no. The primary estimate is the percentage answering "yes". The combined percentage answering "yes" or "not sure" is reported alongside it as a prespecified upper-bound estimate. Both the "yes" and the "not sure" groups are shown the characterisation module and are described separately. Lifetime recall. Unit of measure: percentage of participants.
12 secondary outcomes
PANHIS Sexual Function Index (PSFI) total score
Time frame: Baseline
Sexual satisfaction score
Time frame: Baseline
Sexual self-esteem score
Time frame: Baseline
Percentage of participants in each category of formal sexual education received
Time frame: Baseline
Percentage of participants reporting each category of expanded state of consciousness
Time frame: Baseline
Percentage of participants in each frequency category of expanded states of consciousness
Time frame: Baseline
Percentage of participants reporting each context of occurrence of expanded states of consciousness
Time frame: Baseline
Subjective intensity of expanded states of consciousness
Time frame: Baseline
Self-reported impact of expanded states of consciousness on emotional or spiritual well-being
Time frame: Baseline
Age at first sexual intercourse
Time frame: Baseline
Number of sexual partners in the preceding 12 months
Time frame: Baseline
Percentage of participants reporting a previous sexually transmitted infection
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 18313558von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008.
- Background: PubMed 18064739von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
- Background: PubMed 24286787Mitchell KR, Mercer CH, Ploubidis GB, Jones KG, Datta J, Field N, Copas AJ, Tanton C, Erens B, Sonnenberg P, Clifton S, Macdowall W, Phelps A, Johnson AM, Wellings K. Sexual function in Britain: findings from the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3). Lancet. 2013 Nov 30;382(9907):1817-29. doi: 10.1016/S0140-6736(13)62366-1. Epub 2013 Nov 26.
- Background: PubMed 27799079Safron A. What is orgasm? A model of sexual trance and climax via rhythmic entrainment. Socioaffect Neurosci Psychol. 2016 Oct 25;6:31763. doi: 10.3402/snp.v6.31763. eCollection 2016.
- Background: PubMed 23316089Maclean KA, Leoutsakos JM, Johnson MW, Griffiths RR. Factor Analysis of the Mystical Experience Questionnaire: A Study of Experiences Occasioned by the Hallucinogen Psilocybin. J Sci Study Relig. 2012 Dec;51(4):721-737. doi: 10.1111/j.1468-5906.2012.01685.x.
- Background: PubMed 15451368Komisaruk BR, Whipple B, Crawford A, Liu WC, Kalnin A, Mosier K. Brain activation during vaginocervical self-stimulation and orgasm in women with complete spinal cord injury: fMRI evidence of mediation by the vagus nerves. Brain Res. 2004 Oct 22;1024(1-2):77-88. doi: 10.1016/j.brainres.2004.07.029.
- Background: PubMed 22781787Perez-Lopez FR, Fernandez-Alonso AM, Trabalon-Pastor M, Vara C, Chedraui P; MenopAuse RIsk Assessment (MARIA) Research Group. Assessment of sexual function and related factors in mid-aged sexually active Spanish women with the six-item Female Sex Function Index. Menopause. 2012 Nov;19(11):1224-30. doi: 10.1097/gme.0b013e3182546242.
- Preregistration protocol and statistical analysis plan (Open Science Framework)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual de-identified participant-level data will be made publicly available following publication of the primary results. The dataset will include all variables collected through the online questionnaire, excluding directly identifying information: the email address column, which is optional and used only for assistance with the study incentive and, subject to a separate and independent consent, for recontact regarding future studies, will be removed entirely. The full codebook and the analysis code (R and/or SPSS syntax) will be shared alongside the dataset, via a public repository, to enable replication.
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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.
Silvia P. González Rodríguez, MD, PhD, MSc principal investigator
Universidad Europea del Atlántico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Health and Sexual Dysfunction, Physiological, run by Menoclinica by Palacios at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia P González Rodríguez, MD, PhD, MSc (+34621192307, silviapgonzalez@menoclinica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with self-reported sexual difficulty with associated distress (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT07746297, which also lists 7 linked publications.
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 1 Sep 2026.