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

January 27, 2016 updated by: Antje Horsch, Centre Hospitalier Universitaire Vaudois

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Centre Hôpital Universitaire Vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 week following the emergency cesarean section

Secondary Outcome Measures

Outcome Measure
Time Frame
Posttraumatic Stress Diagnostic Scale (PDS)
Time Frame: 1 month following the emergency cesarean section
1 month following the emergency cesarean section
Acute Stress Disorder Scale (ASDS)
Time Frame: 1 week following the emergency cesarean section
1 week following the emergency cesarean section
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 1 week and 1 month following the emergency cesarean section
1 week and 1 month following the emergency cesarean section

Other Outcome Measures

Outcome Measure
Time Frame
Acceptability of Intervention (rating scale)
Time Frame: 1 month following the emergency cesarean section
1 month following the emergency cesarean section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Collaborators

University of Lausanne Hospitals
Medical Research Council Cognition and Brain Sciences Unit

Investigators

  • Principal Investigator: Antje Horsch, DClinPsych, CHUV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (Estimate)

July 20, 2015

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 480/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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