Perception of Pain During Gender Affirming Hormone Therapy
NCT ID: NCT07148921
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2024-12-01
2026-03-31
Brief Summary
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People undergoing gender affirming therapy receive biologically opposite-sex hormones in order to adapt their external appearance as well as their voice, emotional life etc. to the desired gender. The aim of this study is to longitudinally record whether the intake of opposite-sex sex hormones leads to a change in pain and perception thresholds in this patient collective. To this end, potential study participants will be informed about the study and asked whether they would like to participate before the start of hormone therapy during their first visit to the transgender outpatient clinic.
If consent is given, a questionnaire on mental health (PHQ 9), a blood sample to determine the hormone status and the first QST (quantitative sensory testing) measurement are then carried out. The second measurement with blood sampling takes place 3-4 weeks after the first measurement. The 3rd and 4th measurements with blood sampling are taken 3 and 6 months respectively after the first measurement. The PHQ 9 is measured again at the time of the last measurement. Study participation ends after a total of 6 months. The blood samples, the PHQ 9 and the QST measurements have no influence on the treatment of the study participants.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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AFAB Group
Transgender men and transmasculine individuals
Quantitative Sensory Testing
Quantitative sensory testing (QST) is a psychophysical test procedure. With the help of calibrated stimuli and subjective sensory information, the functional state of the somatosensory system of a subject or patient is examined with regard to the expression of clinical signs.
The test includes:
* Cold detection threshold
* Warm detection threshold
* Paradoxical heat sensation
* Cold pain threshold
* Heat pain threshold
* Mechanical detection threshold
* Mechanical pain threshold
* Mechanical pain sensitivity
* Dynamic mechanical allodynia
* Wind-up phenomena
* Vibration threshold
* Pressure pain threshold
Patient Health Questionnaire 9
The Patient Health Questionnaire 9 (PHQ-9), a validated and internationally used health questionnaire, will also be completed twice at the first study day before the sex hormone therapy is initiated and during the last study day in month 6. The questionnaire consists of 9 items on the topic of mental well-being.
Hormone concentrations
Blood concentrations of the following laboratory parameters will be determined:
* Follicle stimulating hormone (FSH)
* Luteotropic hormone (LH)
* Prolactin (PRL)
* Oestradiol (E2)
* Sex hormone-binding globulin (SHBG)
* Testosterone
AMAB Group
Transgender women and transfeminine individuals
Quantitative Sensory Testing
Quantitative sensory testing (QST) is a psychophysical test procedure. With the help of calibrated stimuli and subjective sensory information, the functional state of the somatosensory system of a subject or patient is examined with regard to the expression of clinical signs.
The test includes:
* Cold detection threshold
* Warm detection threshold
* Paradoxical heat sensation
* Cold pain threshold
* Heat pain threshold
* Mechanical detection threshold
* Mechanical pain threshold
* Mechanical pain sensitivity
* Dynamic mechanical allodynia
* Wind-up phenomena
* Vibration threshold
* Pressure pain threshold
Patient Health Questionnaire 9
The Patient Health Questionnaire 9 (PHQ-9), a validated and internationally used health questionnaire, will also be completed twice at the first study day before the sex hormone therapy is initiated and during the last study day in month 6. The questionnaire consists of 9 items on the topic of mental well-being.
Hormone concentrations
Blood concentrations of the following laboratory parameters will be determined:
* Follicle stimulating hormone (FSH)
* Luteotropic hormone (LH)
* Prolactin (PRL)
* Oestradiol (E2)
* Sex hormone-binding globulin (SHBG)
* Testosterone
Interventions
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Quantitative Sensory Testing
Quantitative sensory testing (QST) is a psychophysical test procedure. With the help of calibrated stimuli and subjective sensory information, the functional state of the somatosensory system of a subject or patient is examined with regard to the expression of clinical signs.
The test includes:
* Cold detection threshold
* Warm detection threshold
* Paradoxical heat sensation
* Cold pain threshold
* Heat pain threshold
* Mechanical detection threshold
* Mechanical pain threshold
* Mechanical pain sensitivity
* Dynamic mechanical allodynia
* Wind-up phenomena
* Vibration threshold
* Pressure pain threshold
Patient Health Questionnaire 9
The Patient Health Questionnaire 9 (PHQ-9), a validated and internationally used health questionnaire, will also be completed twice at the first study day before the sex hormone therapy is initiated and during the last study day in month 6. The questionnaire consists of 9 items on the topic of mental well-being.
Hormone concentrations
Blood concentrations of the following laboratory parameters will be determined:
* Follicle stimulating hormone (FSH)
* Luteotropic hormone (LH)
* Prolactin (PRL)
* Oestradiol (E2)
* Sex hormone-binding globulin (SHBG)
* Testosterone
Eligibility Criteria
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Inclusion Criteria
* Assigned female at birth (AFAB)
* Diagnosed gender identity disorder/gender dysphoria and planned therapy with testosterone OR
* ≥ 18 years of age
* Assigned male at birth (AMAB)
* Diagnosed gender identity disorder/ gender dysphoria and planned therapy with estradiol
Exclusion Criteria
* Acute or chronic pain
* Polyneuropathy
* Diagnosis of alcohol or drug addiction
* BMI under 18 or over 35
* Pregnancy
* Breastfeeding
* Pharmacological analgesic therapy within the previous 7 days before each examination
* History of significant trauma or surgery to the hands with residual neurological deficit or pain.
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Oliver Kimberger
Univ. Prof. PD Dr.
Principal Investigators
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Oliver Kimberger, Prof.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna, Dept. of Anaesthesiology, Critical Care and Pain Medicine
Locations
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Mecial University of Vienna
Vienna, Vienna, Austria
Countries
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Central Contacts
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Facility Contacts
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Monika Dille, MA
Role: primary
Other Identifiers
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1103/2024
Identifier Type: -
Identifier Source: org_study_id