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Completed

NCT Number: NCT02502513

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hôpital Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief computerized intervention

Behavioral

Computer game "Tetris"

Primary outcomes

  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 outcomes

  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 outcomes

  1. Acceptability of Intervention (rating scale)

    Time frame: 1 month following the emergency cesarean section

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 20, 2015
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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