Interindividual differences in stress sensitivity during MR-guided prostate biopsy

Interindividual differences in stress sensitivity during MR-guided prostate biopsy - Stress-biopsy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42574

Enrollment

Registered

2016-06-06

Start date

2016-09-01

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

prostate cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:;- 50 -70 years of age - PSA * 4.0 ng/mL and/or positive digital rectal examination - suspicious lesion (PIRADS 3 to 5) on diagnostic MR imaging examination - Signed MRI screening form (to search for metal device/foreign bodies/claustrophobia) - Signed IRB-approved informed consent form

Exclusion criteria

Exclusion criteria: - Patients unable to undergo MR imaging, including those with contra-indications - Contra-indications to MR-guided prostate biopsy - Impossibility to obtain a valid informed consent - History of psychiatric treatment or current psychiatric treatment as revealed by self report. - History of neurological treatment or current neurological treatment as revealed by self report. - History of endocrine treatment or current endocrine treatment as revealed by self report. - Claustrophobia.

Design outcomes

Primary

Measure	Time frame
The primary objective of our study is to measure individual stress reactivity by means of self-assessment and cortisol changes in patients during MR-guided prostate biopsy.	—

Secondary

Measure	Time frame
The subjective and physiological stress response while undergoing the diagnostic intervention will be associated to potential predictive markers in personality characteristics, habitual stress levels, coping abilities and stress-related brain connectivity patterns. Brain connectivity measures related to stress response, such as the interplay between the human salience and executive control networks [13], stress coping abilities, depression, anxiety, psychological burden and long term stress exposure may constitute vulnerability or resilience factors in relation to the peri-interventional stress response.	—

Measure

Time frame

The subjective and physiological stress response while undergoing the diagnostic intervention will be associated to potential predictive markers in personality characteristics, habitual stress levels, coping abilities and stress-related brain connectivity patterns. Brain connectivity measures related to stress response, such as the interplay between the human salience and executive control networks [13], stress coping abilities, depression, anxiety, psychological burden and long term stress exposure may constitute vulnerability or resilience factors in relation to the peri-interventional stress response.

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Countries

Netherlands

Outcome results