Primary objective: - What is the effect of haptotherapy on fear of childbirth (FOC) in pregnant women with severe FOC?Secondary objectives:- Is there a negative correlation between FOC and emotional bonding of mother and child during pregnancy and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Angst voor de bevalling tijdens de zwangerschap
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fear of childbirth as measured by the WDEQ-A
Secondary outcome
Distress as measured by the 4DSQ
Anxiety as measured by the 4DSQ
Depression as measured by the 4DSQ
Somatization as measured by the 4DSQ
Social support as measured by the SSQ
Anxiety as measured by the HADS
Depression as measured by the HADS
Emotional bond as measured by the PRAM
Trauma anxiety and PTSS as measured by the TES-B.
Pregnancy and childbirth complications as registered in the medical record
Duration of delivery and birth weight as measured by the evaluation
questionnaire
Customer satisfaction as measured by the evaluation questionnaire
Background summary
An identifiable group of pregnant women (6%) suffer from extreme fear of
childbirth (Areskog, Uddenberg and Kjessle 1981) (Saisto and Halmesmäk 2003).
Women with FOC are at increased risk of birth interventions and pre- and
postpartum complications, e.g., Post Traumatic Stress Disorder (Söderquist, et
al. 2009) preterm births (Dole, et al. 2002), emergency cesarean section
(Ryding, Wijma and Wijma 1998), and more caesarean section at the request of
the woman. Dutch figures are not available. Research from England, Sweden and
Finland shows that 7-22% of all caesarean sections are carried out because of
FOC (Ryding 1991) (Atiba, et al. 1993) (Graham, et al. 1999) (I. MacKenzie
1999). Currently no effective therapeutic intervention for reduction fear of
childbirth is scientifically analyzed. A Finnish study reported some positive
effects of psycho-education and relaxation (Saisto, Salmela*Aro, et al. 2011).
Study objective
Primary objective:
- What is the effect of haptotherapy on fear of childbirth (FOC) in pregnant
women with severe FOC?
Secondary objectives:
- Is there a negative correlation between FOC and emotional bonding of mother
and child during pregnancy and postpartum?
- Is there a negative correlation between haptotherapy and complications during
delivery?
Study design
This study is a randomized controlled trial (RCT). All participants will be
tested by the WDEQ-A for FOC and those with a score > 84 will be randomly
assign to the treatment group or control group 1 or control group 2, and
respectively receive haptotherapy, information, care as usual, according to the
protocol. Those women with a score < 85 will be allocated to the comparison
group and followed for the secondary objectives. All therapists involved in the
trial know which kind of intervention must be given to each participating
woman.
Intervention
The intervention group receives haptotherapy.
The control group 1 receives detailed information about pregnancy and
childbirth.
The control group 2 receives care as usual.
Study burden and risks
There are no additional risks associated with participation in the study (a)
since the treatment is a standard haptotherapeutical treatment already
practiced in the some clinics, and (b) those participants in the treatment
group have haptotherapy in addition to care as usual. Participants will
additionally answer questionnaires with in total 120 questions, each time
taking about 20 minutes. The research team has a long and extensive experience
with similar studies with pregnant women. These studies have shown that
participants have no problems to fill out such questionnaires without any
detriment.
Warandelaan 2
Tilburg 5037 AB
NL
Warandelaan 2
Tilburg 5037 AB
NL
Listed location countries
Age
Inclusion criteria
Pregnant women with a WDEQ-A score > 84
Exclusion criteria
Respondents who are already in treatment for haptotherapy and / or haptonomic pregnancy counseling and / or there for other reasons during the research.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL34900.008.11 |
| OMON | NL-OMON23323 |