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

Blood Coagulation Disorder Clinical Trial

— FF8  

Official title:

The Fear F8ctor Study - Does Fear Induce a Blood Curdling State? The Origin Behind the Phrase Unravelled

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601053
• Other study ID #: P15.146
• Secondary ID: NL53805.058.15
• Status: Completed
• Phase: N/A
• First received: November 5, 2015
• Last updated: November 6, 2015
• Start date: June 2015
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Blood Coagulation Disorder
• Blood Coagulation Disorders
• Hemostatic Disorders

Intervention

Other:
• Dull movie
A dull movie (duration approximately 90 minutes)
• Scary (horrifying) movie
A scary movie (duration approximately 90 minutes)
• Heart rate measurement
Heart rate measurement using a actiheart device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Secondary	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.	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.	No
Secondary	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.	VAS scale, directly after dull movie [90 minutes] and directly after scary movie [90 minutes] for each individual	No