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The Neurobiological Basis of the Patient-Practitioner Interaction: A PET Proof of Principle Study

The Neurobiological Basis of the Patient-Practitioner Interaction: A PET Proof of Principle Study - PET study of the patient-practitioner interaction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37330
Enrollment
12
Registered
2012-04-26
Start date
2012-10-17
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

menstruation pain/period pains

Interventions

During a PET scan, participants will watch a video of a physician communicating in an empathic and positive way or watching a video of a physician communicating in an non-empathic way voicing uncert

Sponsors

NIVEL
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
Main outcome parameter is the change in binding potential of [11C]-raclopride in the nucleus accumbens (NAC) as an indication of endogenous dopamine release.

Secondary

MeasureTime frame
Secondary outcome parameters are affective (state anxiety, positive and negative affect states), cognitive (outcome expectations, illness perceptions) and physiological responses (skin conductance, heart rate).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)