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The Fear F8ctor Study - Does Fear Induce a Blood Curdling State? (FF8)

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ClinicalTrials.gov Identifier: NCT02601053
Recruitment Status : Completed
First Posted : November 10, 2015
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
B.Nemeth, Leiden University Medical Center

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.


Condition or disease Intervention/treatment Phase
Blood Coagulation Disorder Other: Dull movie Other: Scary (horrifying) movie Other: Heart rate measurement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: The Fear F8ctor Study - Does Fear Induce a Blood Curdling State? The Origin Behind the Phrase Unravelled
Study Start Date : June 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dull (boring) movie
Participants will be exposed to a dull (i.e. boring) movie followed by a scary (i.e. horrifying) movie.
Other: Dull movie
A dull movie (duration approximately 90 minutes)

Other: Scary (horrifying) movie
A scary movie (duration approximately 90 minutes)

Other: Heart rate measurement
Heart rate measurement using a actiheart device

Experimental: Scary (horrifying) movie
Participants will be exposed to a scary (i.e. horrifying) movie followed by a to a dull (i.e. boring) movie.
Other: Dull movie
A dull movie (duration approximately 90 minutes)

Other: Scary (horrifying) movie
A scary movie (duration approximately 90 minutes)

Other: Heart rate measurement
Heart rate measurement using a actiheart device




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. 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 ]
    A VAS (0-10 points) on fear is recorded from every participant after they have seen the dull and scary movie.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601053


Sponsors and Collaborators
Leiden University Medical Center
Investigators
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Principal Investigator: Banne Nemeth, MD Leiden University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: B.Nemeth, MD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02601053    
Other Study ID Numbers: P15.146
NL53805.058.15 ( Other Identifier: Central Committee on Research Involving Human Subjects )
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders