About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Menoclinica by Palacios
Lead sponsor
Universidad Europea del Atlántico
Collaborator