The Neurobiological Basis of the Patient-Practitioner Interaction: A PET Proof of Principle Study
- Conditions
- menstruation pain/period pains10013326
- Registration Number
- NL-OMON37330
- Lead Sponsor
- IVE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Women between 18 and 45 years of age, who have experienced sufficient menstrual pain (>=40% of maximum imaginable pain on a VAS intensity of pain scale) within the last six months.
Have regular menstrual cycles
Highest empathic scores from the screening and recruitment process (i.e. in highest tertile)
Inability to have an unaided conversation in Dutch
Any neurological disorder
Claustrophobia
Metal objects in or around the body (braces, pacemaker, metal fragments)
Pregnancy, or possibility that the volunteer could be pregnant
Any earlier exposure to radiation in a study as a healthy volunteer leading to cumulative dose of 10 mSv or more.
Pharmacological treatment with dopamine antagonists
Smokers (exclusion from the PET scan section)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main outcome parameter is the change in binding potential of [11C]-raclopride<br /><br>in the nucleus accumbens (NAC) as an indication of endogenous dopamine release. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome parameters are affective (state anxiety, positive and<br /><br>negative affect states), cognitive (outcome expectations, illness perceptions)<br /><br>and physiological responses (skin conductance, heart rate).</p><br>