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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Silvia P González Rodríguez, MD, PhD, MSc contact

+34621192307

silviapgonzalez@menoclinica.com

Menoclínica Research Office contact

+34 914 324 499

menoclinica@menoclinica.com

Spain2 sites, 2 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

    Not yet 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

    Recruiting

Other trials in Spain

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:

  1. sexual health and behaviour epidemiology and associated factors; and
  2. 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.

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 groups in NCT07746297
Study groupRoleWhat they receive
All participantsAdult 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted5 Aug 2026
  2. Study start30 Aug 2026
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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)
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 18313558
  • 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. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.

    PubMed 18064739
  • Mitchell 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 24286787
  • Safron 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 27799079
  • Maclean 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 23316089
  • Komisaruk 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 15451368
  • Perez-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

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.

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