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

• Sponsor: Centre Hospitalier Universitaire Vaudois (Other)
• Overall Status: Completed
• CT.gov ID: NCT02502513
• Collaborator: University of Lausanne Hospitals (Other), Medical Research Council Cognition and Brain Sciences Unit (Other)
• Enrollment: 56
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jun 1, 2013
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. Posttraumatic Stress Diagnostic Scale (PDS) [1 month following the emergency cesarean section]

2. Acute Stress Disorder Scale (ASDS) [1 week following the emergency cesarean section]

3. Hospital Anxiety and Depression Scale (HADS) [1 week and 1 month following the emergency cesarean section]

Other Outcome Measures

1. Acceptability of Intervention (rating scale) [1 month following the emergency cesarean section]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Antje Horsch, DClinPsych, CHUV

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Antje Horsch, Research psychologist, Centre Hospitalier Universitaire Vaudois
• ClinicalTrials.gov Identifier: NCT02502513
• Other Study ID Numbers: 480/2012
• First Posted: Jul 20, 2015
• Last Update Posted: Jan 28, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Disease; Emergencies; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute

Study Results

No Results Posted as of Jan 28, 2016