The Fear F8ctor Study - Does Fear Induce a Blood Curdling State?
FF8
2 other identifiers
interventional
24
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 10, 2015
CompletedMarch 5, 2025
March 1, 2025
2 months
November 5, 2015
March 4, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Change in Factor VIII:C (mean change before and after movie) between movies
The mean change in FVIII:C (in IU/dL) levels after seeing a scary movie (ie from timepoint 0 to 1 in study arm I and from timepoint 2 to timepoint 3 for treatment arm II will be compared to the mean change after seeing a dull movie. A paired student t-test is used to compare the two mean changes in coagulation markers.
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.
Change in D-dimer (mean change before and after movie) between movies
The mean change in D-dimer(in ng/mL) levels after seeing a scary movie (ie from timepoint 0 to 1 in study arm I and from timepoint 2 to timepoint 3 for treatment arm II will be compared to the mean change after seeing a dull movie. A paired student t-test is used to compare the two mean changes in coagulation markers.
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.
Change in Thrombin and Antithrombin complexes (TATc) (mean change before and after movie) between movies
The mean change in TATc (in mcg/L) levels after seeing a scary movie (ie from timepoint 0 to 1 in study arm I and from timepoint 2 to timepoint 3 for treatment arm II will be compared to the mean change after seeing a dull movie. A paired student t-test is used to compare the two mean changes in coagulation markers.
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.
Change in Prothrombin fragments 1+2 (F1+2) (mean change before and after movie) between movies
The mean change in F1+2 (in umol/dL) levels after seeing a scary movie (ie from timepoint 0 to 1 in study arm I and from timepoint 2 to timepoint 3 for treatment arm II will be compared to the mean change after seeing a dull movie. A paired student t-test is used to compare the two mean changes in coagulation markers.
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 (2)
Difference of Heart Rate (peaks in heart rate) between movies
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.
Difference of the Visual Analogue Scale on Fear between movies
VAS scale, directly after dull movie [90 minutes] and directly after scary movie [90 minutes] for each individual
Study Arms (2)
Dull (boring) movie
ACTIVE COMPARATORParticipants will be exposed to a dull (i.e. boring) movie followed by a scary (i.e. horrifying) movie.
Scary (horrifying) movie
EXPERIMENTALParticipants will be exposed to a scary (i.e. horrifying) movie followed by a to a dull (i.e. boring) movie.
Interventions
A dull movie (duration approximately 90 minutes)
A scary movie (duration approximately 90 minutes)
Heart rate measurement using a actiheart device
Eligibility Criteria
You may qualify if:
- Healthy volunteers between 18 and 30 years old
- No medication and otherwise healthy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 26673787DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Banne Nemeth, MD
Leiden University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 5, 2015
First Posted
November 10, 2015
Study Start
June 1, 2015
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
March 5, 2025
Record last verified: 2025-03