Perception of Pain During Gender Affirming Hormone Therapy

Summary

It is known from the literature that women and men differ in their perception of pain. Why this is the case has not been conclusively clarified. Sex hormones could have a significant influence on this. The study team suspects that the classic hormone status of women is responsible for the lower pain threshold compared to men.

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.

Conditions

• Transgender Persons
• Pain Threshold
• Perception of Pain
• Sex Hormones

Interventions

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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

Sponsors & Collaborators

• Medical University of Vienna

  lead OTHER

Principal Investigators

• Oliver Kimberger, Prof. · Medical University of Vienna, Dept. of Anaesthesiology, Critical Care and Pain Medicine

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-01

Primary Completion

2025-12-31

Completion

2026-03-31

Countries

• Austria

Study Locations