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Two-Arm Mixed-Methods Feasibility Study on the Use of a Mobile Application for Individuals Affected by Endometriosis and Sexual Dysfunction

Two-Arm Mixed-Methods Feasibility Study on the Use of a Mobile Application for Individuals Affected by Endometriosis and Sexual Dysfunction - GYDE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034351
Enrollment
60
Registered
2024-06-07
Start date
2024-07-18
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N80 F52

Interventions

Group 1: Intervention Group: Participants in the intervention group will be given access to the digital intervention after enrollment. This intervention consists of 8 modules that participants can com

Sponsors

Institut für Sexualwissenschaft und Sexualmedizin
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • (Suspected) diagnosis of endometriosis with a report • Sexual distress due to sexual dysfunction

Exclusion criteria

Exclusion criteria: • Major depression • Severe anxiety disorder • Suicidal ideation in the past 5 years • Current post-traumatic stress disorder • Substance dependence in the past 2 years • Acute psychosis • Current pregnancy

Design outcomes

Primary

MeasureTime frame
The aim is to investigate feasibility using a mixed methods approach in terms of acceptability, adherence, and safety. Exploratory changes will be measured on the following scales: • Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS) (t1, t2, t3, t4) • Female Sexual Function Index (FSFI-d) (t1, t2, t3, t4) • Sexual Self-Esteem Inventory (SSEI-d) (t1, t2, t3, t4) • Inventory of Sexuality Functions (3D) (t1, t2, t3, t4) • Questionnaire on Resources in Sexuality and Partnership (RSP) (t1, t2, t3, t4) • Partnership Questionnaire (PFB) (t1, t3, t4) • Patient-Reported Outcome Measurement Information System (PROMIS-29) (t1, t2, t3, t4) • EUROHIS-QOL (t1, t3, t4) • Fear of Sexuality Questionnaire (FSQ) (t1, t2, t3, t4) • Vaginal Penetration Cognition Questionnaire (VPCQ) (t1, t2, t3, t4) • Central Sensitization Inventory German Version (CSI-GE) (t1, t2, t3, t4) • International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) (t1, t2, t3, t4) • Perceived Stress Scale (PSS-10) (t1, t2, t3, t4) • Beck Depression Inventory (BDI-II) (t1, t3) • Generalized Anxiety Disorder Questionnaire (GAD-7) (t1, t3) • Brief Symptom Inventory (BSI) (t1, t3) • Perceived Services in the Healthcare System (t1, t3, t4) Additional for Intervention Group: • Satisfaction with the intervention on a visual analog scale (1-10) (t3) • Client Satisfaction Questionnaire with Internet Interventions (CSWIQ-8) (t2, t3) • mHealth App Usability Questionnaire (G-MAUQ) (t2, t3) • Inventory for the Assessment of Negative Effects in Psychotherapy (INEP) (t3, t4) • Serious Adverse Events (SAE) (t1-t3) • Dropout (t1-t4)

Countries

Austria, Germany, Switzerland

Contacts

Public ContactSelina Kronthaler

Institut für Sexualwissenschaft und Sexualmedizin

gyde-research@charite.de+49 30 450 529 302

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 20, 2026