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The PANHIS Study: Sexual Health in Spanish-Speaking Adults - A Cross-Sectional Online Survey (PANHIS)

30. srpna 2026 aktualizováno: Menoclinica by Palacios

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.

Přehled studie

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

15000

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

    • Cantabria
      • Santander, Cantabria, Španělsko, 39011
        • Nábor
        • Universidad Europea del Atlántico - Cátedra de Sexología y Salud (Coordinating Center for Online Study)
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Silvia P. González Rodríguez, MD, PhD, MSc
    • Madrid
      • Madrid, Madrid, Španělsko, 28009
        • Zatím nenabíráme
        • Menoclínica S.L. (Collaborating Center for Online Study)
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Silvia P. González Rodríguez, MD, PhD, MSc
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of participants with self-reported sexual difficulty with associated distress
Časové okno: 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.
Baseline
Percentage of participants reporting expanded states of consciousness associated with orgasm
Časové okno: 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.
Baseline

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
PANHIS Sexual Function Index (PSFI) total score
Časové okno: Baseline
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.
Baseline
Sexual satisfaction score
Časové okno: Baseline
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.
Baseline
Sexual self-esteem score
Časové okno: Baseline
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.
Baseline
Percentage of participants in each category of formal sexual education received
Časové okno: Baseline
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.
Baseline
Percentage of participants in each frequency category of expanded states of consciousness
Časové okno: Baseline
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.
Baseline
Percentage of participants reporting each context of occurrence of expanded states of consciousness
Časové okno: Baseline
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.
Baseline
Subjective intensity of expanded states of consciousness
Časové okno: Baseline
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.
Baseline
Self-reported impact of expanded states of consciousness on emotional or spiritual well-being
Časové okno: Baseline
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.
Baseline
Age at first sexual intercourse
Časové okno: Baseline
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.
Baseline
Number of sexual partners in the preceding 12 months
Časové okno: Baseline
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.
Baseline
Percentage of participants reporting a previous sexually transmitted infection
Časové okno: Baseline
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.
Baseline
Percentage of participants reporting each category of expanded state of consciousness
Časové okno: Baseline
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.
Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Silvia P. González Rodríguez, MD, PhD, MSc, Universidad Europea del Atlántico

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

30. srpna 2026

Primární dokončení (Odhadovaný)

1. října 2026

Dokončení studie (Odhadovaný)

1. prosince 2026

Termíny zápisu do studia

První předloženo

28. července 2026

První předloženo, které splnilo kritéria kontroly kvality

31. července 2026

První zveřejněno (Aktuální)

5. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

Data will become available within 12 months after publication of the main manuscript, with no fixed end date.

Kritéria přístupu pro sdílení IPD

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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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