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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02502513
Other study ID # 480/2012
Secondary ID
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


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
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