We want to evaluatie wether or not support and assistance in processing this trauma through the use of EMDR, a proven therapy for PTSD, could be of use for women without an official diagnosis, but with significant residual complaints.
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Psychological complaints.
Has there been psychiatric treatment? If yes, which institute, diagnosis and
duration of treatment.
Secondary outcome
Scores on the questionnaires
Time off work.
Background summary
Around 10-15% of women who give birth in the Netherlands each year (which is
around 170.000 women in total) recall their birth as a traumatic experience.
Only 1-3% of the entire group fulfills the criteria for a Post Traumatic Stress
Disorder (PTSD). The others do not qualify for an official psychiatric
diagnosis, but frequently have complaints, like flashbacks, nightmares,
hyperarousal (fear), postponing a new pregnancy, being unable to view photos of
the birth, etc. Except for the standard pospartum check-up, there is no
aftercare for these women.
If these women are not provided with help in processing this birth trauma, this
may lead to other psychological issues, such as disorders of fear and
depression, but also to problems bonding with the child, being unable to resume
work (burn-out), and problems with the relationship with the partner.
Study objective
We want to evaluatie wether or not support and assistance in processing this
trauma through the use of EMDR, a proven therapy for PTSD, could be of use for
women without an official diagnosis, but with significant residual complaints.
Study design
This study concerns women who, during a check-up by telephone after 3 weeks
(and/or a check-up in person after 6 weeks), indicate that they experienced the
birth as unpleasant or traumatic. Both check-ups are already part of standard
practice. These women are asked if they are willing to get information about a
study in the Radboudumc bij there gynaecologist. The gynaecologist will inform
the patient and gives the patient the informend consent. If they agree, they
will receive a call from Nicole van Voorst, to make an appointment and tot fill
in the 2 questionnaires (see earlier) with them.
If the women fall into the category suitable for this study, they will, , be
randomised allocated to either the EMDR group or the control group.
All women will be asked to fill out several questionnaires screening for the
problems mentioned above at times T=0, 3 months, 6 months and 12 months. This
concerns a explorative study, for which we will include women during one year
in a single center (the Radboudumc).
Intervention
EMDR (1-3 sessions).
Study burden and risks
Because there is no treatment for these women in the regular situation, there
is no risk in not getting the treatment if they end up in the control group.
There is even a benefit, because the will be followed for over a year and we
will give them medical and psychological advise if necesecarry over the year.
We also will inform the family doctor that the patient is in this trail. An
EMDR treatment can cause short term emotions during the EMDR session, however,
without treatment those emotions will also be present because you work with the
subjective unit of distress (SUD) in the present time. Not treated, the
emotions will stay longer and probably be much stronger. At the end of an EMDR
session the SUD is lower then at the start, as a result of the effect of the
EMDR. This means that there will be a direct relief of tension after the EMDR
session. The most common side effect of EMDR is tiredness in the first 24 hours
after treatment. After 24 hours there will be contact with the psychologist, by
email to check how the first day went. If there is a reason to contact the
patient by phone, or to make an appointment this will be done and adequate
interventions will be made.
Since there is currently no treatment offered to these women, the treatment
group is certainly no worse off, and possibly better, than the control group.
It will take participants 4 times approximately 20 minutes to fìll out the
questionnaires and 2 hours of interview,
Geert Grooteplein Zuid 10
Nijmegen 6525 DA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 DA
NL
Listed location countries
Age
Inclusion criteria
A traumatic childbirth experience, and a score on the PCL-5 questionnaire of
<33, and on the PPQ questionnaire of >/<=19.
A sufficient knowledge of the Dutch language.
Age >/<= 18 years.
Exclusion criteria
No traumatic childbirth experience, of a traumatic childbirth experience, but a
score on the PCL-5 questionnaire of >33, or on the PPQ questionnaire of <19.
Insufficient knowledge of the Dutch language.
Age < 18 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL69127.091.19 |