Reinhard 2012.
Methods | RCT comparing 2 interventions (clinical hypnosis or NLP) (a control group receiving no intervention was used as a historical comparison – data for this group have not been included in the review). Single‐centre, stratified by parity. | |
Participants | Control group. From January 1, 2009, to October 31, 2010, a control group were all ECVs, during which time neither hypnosis nor NLP was used. These data will not be included. Setting: a tertiary university hospital in Germany. Johann Wolfgang Goethe University Hospital in Frankfurt am Main. Inclusion criteria: pregnant women with a singleton fetus in a breech position at the scheduled date of the ECV at or after 370/7 (259 days) weeks' gestation, normal amniotic fluid index, with advanced level of German language. N = 80. Exclusion criteria: women in active labour (regular uterine contractions and rupture of membranes), contraindications for a vaginal birth (such as placenta praevia) and planned birth by caesarean section even if the fetus turned to a cephalic position. |
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Interventions |
Experimental intervention: hypnosis. 20‐Minute standardized clinical hypnosis intervention via head phones (Bose, QuietComfort 15) before ECV procedure was carried out. Hypnosis intervention was a voice recording of one of the trialists (a certified hypnotherapist who underwent training in the fundamentals of NLP). A relaxation induction was utilised, in which the therapist focused on breathing and concentrated on various parts of the body for trance deepening. N = 42. Control/Comparison intervention: neurolinguistic programming. 20‐Minute standardised NLP intervention via head phones (Bose, QuietComfort 15) before ECV procedure was carried out. Hypnosis intervention was a voice recording of 1 of the trialists (a certified hypnotherapist who underwent training in the fundamentals of NLP). N = 38. |
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Outcomes | ECV success; women’s views (results reported as means derived from Likert 6‐point scale). | |
Notes | We contacted the study author for more information re the NLP intervention and received additional information. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Off‐centre randomisation sequence based on block randomisation was calculated and assigned by the Institute of Biostatistics and Mathematical Modeling. |
Allocation concealment (selection bias) | Unclear risk | Allocation at the point of randomisation was not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Intervention was double‐blinded, that is, the participant and the clinician who carried out the ECV procedure did not know the kind of intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Intervention was double‐blinded, that is, the participant and the clinician who carried out the ECV procedure did not know the kind of intervention. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up evident after randomisation. |
Selective reporting (reporting bias) | Unclear risk | We did not assess trial protocol. |
Other bias | Low risk | Other bias not apparent. |