Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02502513
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : January 28, 2016
Sponsor:
Collaborators:
University of Lausanne Hospitals
Medical Research Council Cognition and Brain Sciences Unit
Information provided by (Responsible Party):
Antje Horsch, Centre Hospitalier Universitaire Vaudois

Brief 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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Acute Stress Disorder Behavioral: Brief computerized intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Can Playing Tetris Prevent the Development of Traumatic Intrusions in Mothers Following an Emergency Cesarean Section? A Pilot Study
Study Start Date : June 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Brief computerized intervention (computer game "Tetris") plus usual care in the maternity department and completion of intrusive memory diary
Behavioral: Brief computerized intervention
Computer game "Tetris"

No Intervention: Control
Usual care in the maternity department plus completion of intrusive memory diary



Primary Outcome Measures :
  1. Number of intrusive memories recorded by participants in an intrusive memory diary in the week after the emergency cesarean section [ Time Frame: 1 week following the emergency cesarean section ]

Secondary Outcome Measures :
  1. Posttraumatic Stress Diagnostic Scale (PDS) [ Time Frame: 1 month following the emergency cesarean section ]
  2. Acute Stress Disorder Scale (ASDS) [ Time Frame: 1 week following the emergency cesarean section ]
  3. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 1 week and 1 month following the emergency cesarean section ]

Other Outcome Measures:
  1. Acceptability of Intervention (rating scale) [ Time Frame: 1 month following the emergency cesarean section ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02502513


Locations
Layout table for location information
Switzerland
Centre Hôpital Universitaire Vaudois
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
University of Lausanne Hospitals
Medical Research Council Cognition and Brain Sciences Unit
Investigators
Layout table for investigator information
Principal Investigator: Antje Horsch, DClinPsych CHUV

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Antje Horsch, Research psychologist, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02502513     History of Changes
Other Study ID Numbers: 480/2012
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Emergencies
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic, Acute
Pathologic Processes
Disease Attributes
Trauma and Stressor Related Disorders
Mental Disorders