An observational study in Sexual Health, Sexual Dysfunction, Physiological and Sexual Dysfunctions, Psychological, sponsored by Menoclinica by Palacios. Recruiting at 2 sites in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Menoclinica by Palacios · Observational
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:
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.
"A secondary, non-confirmatory analysis of menopausal stage (premenopause, menopausal transition, postmenopause; women aged 40-60) and sexual difficulty with associated distress was registered on OSF (10.17605/OSF.IO/7DRSM) on 3 November 2026, after inspection of interim data, and is declared as such."
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's planned enrollment of 15,000 is above the median of 165 across 30 observational studies indexed under Dyspareunia.
Browse Dyspareunia studies →Menoclinica by Palacios is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Compared within Dyspareunia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sexual Dysfunction, Physiological. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Refusal of
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: Baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Association between menopausal stage and self-reported sexual difficulty with associated distress (women aged 40-60)
Prevalence of sexual difficulty with associated distress (any PSFI domain score 0-1 and distress item ≥2) by menopausal stage (premenopause: regular cycles; menopausal transition: irregular cycles in the last year or 3-11 months of amenorrhea; postmenopause: ≥12 months of amenorrhea), with age-adjusted and recruitment-source-adjusted estimates. Secondary, non-confirmatory analysis added after interim data inspection; registered on OSF (10.17605/OSF.IO/7DRSM)
Time frame: Single assessment at survey completion (cross-sectional; data collection from 30 August 2026 to closing date)
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will become available within 12 months after publication of the main manuscript, with no fixed end date.
Access criteria: Data and analytic code will be openly accessible under a Creative Commons license (CC BY 4.0 or equivalent) through a public repository, with no application or approval process required. Users are expected to cite the original publication and the dataset DOI.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2026, 4 months after the start.
Primary completion moved once since we started tracking on Sep 25, 2026: Oct 2026 → Dec 2026, on Nov 9, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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