|- candidate number||11272|
|- NTR Number||NTR3339|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-mrt-2012|
|- Secondary IDs||NL34900.008.11 METC Elisabeth Ziekenhuis Tilburg|
|- Public Title||Wetenschappelijk Onderzoek Bevallingsbeleving.|
|- Scientific Title||Treatment of severe fear of childbirth with haptotherapy.|
|- hypothesis||1. In the TrG "Fear Of Childbirth" (FOC) will decrease from Time 1-3;|
2. In the ContrG1 FOC will decrease from Time 1-3;
3. The decrease of FOC from Time 1-3 will be larger in the TrG than in the ContrG1 and ContrG2;
4. At Time 4 the mean scores of FOC will be TrG < ContrG1 < ContrG2;
5. FOC and bonding with their child during pregnancy and postpartum will correlate negatively;
6. Women in the TrG have less birth complications than women in the control groups (ContrG1 and ContrG2).
|- Healt Condition(s) or Problem(s) studied||Delivering women, Labour, Anxiety, Haptotherapy|
|- Inclusion criteria||1. Pregnant women;|
2. WDEQ-A score > 84;
3. Age > 17.
|- Exclusion criteria||1. Multiparity;|
2. Pregnant women who recently or in the past have experienced a psychotic episode;
3. Medical illnesses, which would severely interfere with haptotherapy.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2012|
|- planned closingdate||31-dec-2015|
|- Target number of participants||192|
|- Interventions||The study has three groups:
1. Therapy group;|
2. Control group with information;
3. Control group with Care as Usual.
The therapy group will receive haptotherapy. The control group with information will receive detailed information about pregnancy and delivery. The control group Care as Usual will receive the care usually given in the concerned practice.
Haptotherapy for pregnant women with FOC is a combination of skills, learned in eight sessions of one hour between week 16 and 35 of the gestation.
|- Primary outcome||Fear of childbirth as measured by the WDEQ-A.|
|- Secondary outcome||1. Distress as measured by the 4DSQ;|
2. Anxiety as measured by the 4DSQ;
3. Depression as measured by the 4DSQ;
4. Somatization as measured by the 4DSQ;
5. Social support as measured by the SSQ;
6. Anxiety as measured by the HADS;
7. Depression as measured by the HADS;
8. Emotional bond as measured by the PRAM;
9. Trauma anxiety and PTSS as measured by the TES-B;
10. Pregnancy and childbirth complications as registered in the medical record;
11. Duration of delivery and birth weight as measured by the evaluation questionnaire;
12. Customer satisfaction as measured by the evaluation questionnaire.
|- Timepoints||1. Admission to the study in week 20-24 of gestation;|
2. In week 36 of gestation;
3. Six weeks postpartum;
4. Six months postpartum.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| G.A. Klabbers|
|- CONTACT for SCIENTIFIC QUERIES|| G.A. Klabbers|
|- Sponsor/Initiator ||Tilburg University|
(Source(s) of Monetary or Material Support)
|- Brief summary||An identifiable group of pregnant women (6%) suffer from FOC (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 caesarean section at the request of the woman. Dutch prevalence 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 FOC is scientifically analyzed. A Finnish study reported some positive effects of psycho-education and relaxation (Saisto, Salmela‐Aro, et al. 2011). The present 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 assigned to the treatment group or control group 1 or control group 2, and respectively receive haptotherapy (TrG), information (ContrG1), care as usual (ContrG2), according to the protocol. Those women with a score < 85 will be allocated to a 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.|
|- Main changes (audit trail)|
|- RECORD||4-mrt-2012 - 25-okt-2014|