Blood Coagulation DisorderFF8NCT02601053
The Fear F8ctor Study - Does Fear Induce a Blood Curdling State?
A study testing Dull movie, Scary (horrifying) movie and Heart rate measurement in people with Blood Coagulation Disorder, run by Leiden University Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Coagulation Disorder
- What is being tested?
- Dull movie, Scary (horrifying) movie and Heart rate measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers between 18 and 30 years old
- No medication and otherwise healthy
Who cannot join
- 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
About this study
Official title: The Fear F8ctor Study - Does Fear Induce a Blood Curdling State? The Origin Behind the Phrase Unravelled
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.
Read the 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.
- Conditions
- Blood Coagulation Disorder
- Being tested
- Dull movie, Scary (horrifying) movie, Heart rate measurement
- Medical subject headings
- Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dull movieOther
A dull movie (duration approximately 90 minutes)
Scary (horrifying) movieOther
A scary movie (duration approximately 90 minutes)
Heart rate measurementOther
Heart rate measurement using a actiheart device
| Study group | Role | What they receive |
|---|---|---|
| Dull (boring) movie | Active comparator | Participants will be exposed to a dull (i.e. boring) movie followed by a scary (i.e. horrifying) movie. Receives: Other: Dull movie; Other: Scary (horrifying) movie; Other: Heart rate measurement |
| Scary (horrifying) movie | Experimental | Participants will be exposed to a scary (i.e. horrifying) movie followed by a to a dull (i.e. boring) movie. Receives: Other: Dull movie; Other: Scary (horrifying) movie; Other: Heart rate measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Heart rates will be measures in beats per minute during the entire movie, using an actiheart device that monitores the heart rate every 15 seconds.
Measured: 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
A VAS (0-10 points) on fear is recorded from every participant after they have seen the dull and scary movie.
Measured: VAS scale, directly after dull movie [90 minutes] and directly after scary movie [90 minutes] for each individual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Coagulation DisorderStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, B.Nemeth, Leiden University Medical Center
- Investigators
- Banne Nemeth, MD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601053
- Sponsor's protocol ID
- P15.146
- Other IDs
- NL53805.058.15
- Acronym
- FF8
- Status last verified
- Mar 2025
- First submitted
- 5 Nov 2015
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26673787
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fear F8ctor Study - Does Fear Induce a Blood Curdling State? The Origin Behind the Phrase Unravelled
- ClinicalTrials.gov ID
- NCT02601053
- Acronym / sponsor ID
- FF8 / P15.146
- Conditions
- Blood Coagulation Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dull (boring) movie | Active comparator | Other: Dull movie, Other: Scary (horrifying) movie, Other: Heart rate measurementParticipants will be exposed to a dull (i.e. boring) movie followed by a scary (i.e. horrifying) movie. |
| Scary (horrifying) movie | Experimental | Other: Dull movie, Other: Scary (horrifying) movie, Other: Heart rate measurementParticipants will be exposed to a scary (i.e. horrifying) movie followed by a to a dull (i.e. boring) movie. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers between 18 and 30 years old
- No medication and otherwise healthy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dull movieA dull movie (duration approximately 90 minutes) | Other | Dull (boring) movie, Scary (horrifying) movie |
| Scary (horrifying) movieA scary movie (duration approximately 90 minutes) | Other | Dull (boring) movie, Scary (horrifying) movie |
| Heart rate measurementHeart rate measurement using a actiheart device | Other | Dull (boring) movie, Scary (horrifying) movie |
Primary outcome
Change in Factor VIII:C (mean change before and after movie) between movies
Time frame: 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.
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.
Change in D-dimer (mean change before and after movie) between movies
Time frame: 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.
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.
Change in Thrombin and Antithrombin complexes (TATc) (mean change before and after movie) between movies
Time frame: 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.
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.
Change in Prothrombin fragments 1+2 (F1+2) (mean change before and after movie) between movies
Time frame: 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.
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.
2 secondary outcomes
Difference of Heart Rate (peaks in heart rate) between movies
Time frame: 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
Time frame: VAS scale, directly after dull movie [90 minutes] and directly after scary movie [90 minutes] for each individual
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Derived from this study: PubMed 26673787Nemeth 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.
Related trials for Blood Coagulation Disorder
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Banne Nemeth, MD principal investigator
Leiden University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Dull movie, Scary (horrifying) movie and Heart rate measurement in people with Blood Coagulation Disorder, run by Leiden University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Factor VIII:C (mean change before and after movie) between movies (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02601053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.