Clinical trial NCT02601053: The Fear F8ctor Study - Does Fear Induce a Blood Curdling State?
Official title: The Fear F8ctor Study - Does Fear Induce a Blood Curdling State? The Origin Behind the Phrase Unravelled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Coagulation Disorder
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: For centuries the term "blood curling" has been used to describe extreme frightening situations. However, the origin of this ancient theory has never been studied and it remains unknown if fear induces the coagulation system.The objective was to explore the effects of acute fear on the coagulation system while sitting still. In a crossover study design healthy subjects will be exposed to a horrifying e.g. scary movie followed by a dull e.g. flat movie which is shown at least 1 week after the first movie on the same day of the week at the same time of the day. Participants will be recruited among students from the Leiden University Medical Center. Blood will be drawn from the cubital vein 10 minutes before the first movie, directly after the first movie. The same will be done 10 minutes before and directly after the second movie. Blood is drawn by using a needle puncture.

Individual markers of coagulation activity will be determined from the blood samples. Pulse rates will be measured and an anxiety/fear score will be collected from each student for both movies.

Detailed description: Rationale: For centuries the term "blood curling" has been used to describe extreme frightening situations. The term dates back to the medieval physiology, it was believed that the human body contained four chief fluids, blood, phlegm, bile and black bile. It was thought that fear or horror would 'run the blood cold' or 'curdle' (solidify). To date large parts of the complex mechanism of the coagulation cascade have been unravelled and many risk factors for clotting, i.e., thrombosis have been identified. However, the origin of this ancient theory has never been studied and it remains unknown if fear induces the coagulation system.

Objective: To explore the effects of acute fear on the coagulation system while sitting still.

The investigators will compare systemic coagulation markers before and after both movies in each subject: 13 subjects will be exposed to the horrifying movie first, followed by the dull movie (at least 1 week later). Both movies will be shown on the same day of the week, at the same time of the day and will last approximately 90 minutes. One group of 13 will first view the horrifying movie, followed by the dull move the next week (Group I) and 13 subjects will be exposed to the dull movie first, followed by the horrifying movie (Group II). Spacious seats will be used to avoid the effect of immobilisation due to tight cinema seats. Blood is drawn at four time points (TP); (0) before the first movie (baseline), after the first movie (1), before the second movie (2) and after the second movie (3). A needle puncture is used to collect 12 ml of blood at each time point.

Individual markers of coagulation activity will be determined from the blood samples. Pulse rates will be measured and an anxiety/fear score will be collected from each student for both movies.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between 18 and 30 years old
* No medication and otherwise healthy

Exclusion Criteria:

* Any coagulation disorder
* Hormonal anticonception (excluding intrauterine devices)
* Pregnancy or puerperium
* History of Venous thrombosis
* Major surgery or cast immobilisation in the past two months
* Neoplasm or inflammatory disease

Primary outcomes:
measure: Change in Factor VIII:C (mean change before and after movie) between movies
timeFrame: Four time points (TP); (0) before the first movie (baseline), after the first movie [90 minutes](1), before the second movie (baseline, 2) and after the second movie [90 minutes](3). All blood will be drawn within 15 minutes before or after the movie.
measure: Change in D-dimer (mean change before and after movie) between movies
timeFrame: Four time points (TP); (0) before the first movie (baseline), after the first movie [90 minutes](1), before the second movie (baseline, 2) and after the second movie [90 minutes](3). All blood will be drawn within 15 minutes before or after the movie.
measure: Change in Thrombin and Antithrombin complexes (TATc) (mean change before and after movie) between movies
timeFrame: Four time points (TP); (0) before the first movie (baseline), after the first movie [90 minutes](1), before the second movie (baseline, 2) and after the second movie [90 minutes](3). All blood will be drawn within 15 minutes before or after the movie.
measure: Change in Prothrombin fragments 1+2 (F1+2) (mean change before and after movie) between movies
timeFrame: Four time points (TP); (0) before the first movie (baseline), after the first movie [90 minutes](1), before the second movie (baseline, 2) and after the second movie [90 minutes](3). All blood will be drawn within 15 minutes before or after the movie.
Secondary outcomes:
measure: Difference of Heart Rate (peaks in heart rate) between movies
timeFrame: During the entire movie the heart rate is recorded [up to 90 minutes]. Heart rate peaks (above average) will be compared between movies in one individual.
measure: Difference of the Visual Analogue Scale on Fear between movies
timeFrame: VAS scale, directly after dull movie [90 minutes] and directly after scary movie [90 minutes] for each individual
Other outcomes:
Locations:
Study officials:
affiliation: Leiden University Medical Center
name: Banne Nemeth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nemeth B, Scheres LJ, Lijfering WM, Rosendaal FR. Bloodcurdling movies and measures of coagulation: Fear Factor crossover trial. BMJ. 2015 Dec 16;351:h6367. doi: 10.1136/bmj.h6367.