Prevention of Intrusive Memories and Posttraumatic Stress Symptoms After Emergency Cesarean Section

Posttraumatic Stress Disorder Clinical Trial

Official title:

Can Playing Tetris Prevent the Development of Traumatic Intrusions in Mothers Following an Emergency Cesarean Section? A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502513
• Other study ID #: 480/2012
• Status: Completed
• Phase: N/A
• First received: July 16, 2015
• Last updated: January 27, 2016
• Start date: June 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

This pilot study aims to investigate the effects of a brief computerized intervention (the computer game "Tetris") on intrusive memories and other posttraumatic stress symptoms following an emergency cesarean section. Patients who have undergone an emergency cesarian section will be randomly allocated to either the brief computerized intervention or usual care within the first 6 hours following the operation. Participants will be followed up at one week and one month. It is predicted that participants given the brief computerized intervention will develop fewer intrusive memories and less severe clinical symptoms than those who are not. This will inform the potential future development of a simple computerized intervention to prevent distressing psychological symptoms after a traumatic event such as an emergency cesarean section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female, aged 18+ years

• Had emergency caesarean section within the past 6 hours

• Have given birth to a live baby at = 37 weeks gestation

Exclusion Criteria:

• Do not speak French sufficiently well to participate in assessments

• Have established intellectual disability or psychotic illness

• Baby was transferred to intensive care unit after the birth

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Stress Disorder
• Disease
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Stress Disorders, Traumatic, Acute

Intervention

Behavioral:
• Brief computerized intervention
Computer game "Tetris"

Locations

Country	Name	City	State
Switzerland	Centre Hôpital Universitaire Vaudois	Lausanne	Vaud

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	Medical Research Council Cognition and Brain Sciences Unit, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability of Intervention (rating scale)		1 month following the emergency cesarean section	No
Primary	Number of intrusive memories recorded by participants in an intrusive memory diary in the week after the emergency cesarean section		1 week following the emergency cesarean section	No
Secondary	Posttraumatic Stress Diagnostic Scale (PDS)		1 month following the emergency cesarean section	No
Secondary	Acute Stress Disorder Scale (ASDS)		1 week following the emergency cesarean section	No
Secondary	Hospital Anxiety and Depression Scale (HADS)		1 week and 1 month following the emergency cesarean section	No

External Links

•   Study investigating a related computerized intervention after a road traffic accident in a hospital Emergency Department