Mental Training and Childbirth

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ClinicalTrials.gov Identifier: NCT00914082

Recruitment Status : Completed

First Posted : June 4, 2009

Last Update Posted : March 18, 2013

Sponsor:

Collaborator:

Aarhus University Hospital

Information provided by (Responsible Party):

University of Aarhus

Study Description

Brief Summary:

Labour pain is a challenge to the parturient woman. Pain relief methods during birth are limited and often associated with side effects. Several studies indicate that a mental trainings method, self hypnosis, has a positive impact on the labour pain and other birth outcomes.

The aim of this randomized controlled study is to examine the effect of a short antenatal course in self hypnosis on the use of epidural analgesia during birth and several other birth outcomes. Data collection includes questionnaires, register data, medical records and biological material.

Condition or disease	Intervention/treatment	Phase
Childbirth Pain	Behavioral: Self hypnosis	Not Applicable

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Detailed Description:

Background:

Experiencing labour pain is a challenge to the parturient woman and can possibly cause a traumatic birth experience, post traumatic stress syndrome, post partum depression, caesarean section or refraining from having more children.

Pharmacological pain relief methods to relieve birth pain are limited and often associated with side effects. Investigating new methods without adverse effects to relieve labour pain is therefore important.

Several studies indicate that a mental trainings method, self-hypnosis, has a positive impact on labour pain and several other birth outcomes. However, many of these studies were based on observational data with a limited amount of participants that may be prone to bias and confounding.

Aim:

The aim of this study is to examine the effect of a short antenatal course in self hypnosis on the use of epidural analgesia during childbirth.

Method:

The study is designed as an interventional single center study taking place at one of the largest birth departments in Denmark. It is a randomised, controlled, single blinded trial using a 3 arm group design.

The participants will be randomised by a voice respond program. The intervention group receives 3 antenatal classes in self hypnosis taught by midwives with qualified training in hypnosis. The course includes audio compact discs for homework in self hypnosis.

The active comparator group also receives 3 antenatal classes. The program is taught by the same midwives as in the intervention group and includes a mixture of training in different relaxation methods and mindfulness. This course also includes audio compact discs for homework.

The control group will only receive ordinary antenatal care and no additional interventions.

The data collection will be based on questionnaires, register data, medical records and biological material.

The endpoints are:

Primary:

The use of epidural analgesia during birth

Secondary:

Length of birth
Birth progression at arrival at birth department
Birth experience (pain, control, anxiety)
Medical interventions during birth including mode of delivery
Hemorrhage during birth
Saliva cortisol profile at birth and 6 weeks p.p.
Infection during birth and the first 6 weeks p.p. (mother and child)
Postnatal depression
Breastfeeding duration
Child's condition and wellbeing at birth and 6 months later
Future mode of delivery

At the start of the study, we performed our power calculations based on the fact that 44% of all primiparas at Aarhus University Hospital Skejby in 2007 had received epidural analgesia. We hypothesized that the observed frequency of epidural analgesia would be 25 % in the intervention group, 35 % in the placebo effect group and 40 % in the placebo group.

According to these power calculations, we should include 328 participants in the hypnosis group, 328 participants in the active comparator group and 152 participants in the control group to obtain a power of 80 % (α 0.05 (two sided)) in detecting a difference of 5 percentage points (relative risk (RR) 0.71) between the intervention and the active comparator group. By including 152 participants in the control group we would have a larger power to detect a difference of 15 percentage points (RR 0.63) in the use of epidural analgesia between the intervention and the control group.

Because we expected that some participants would develop medical conditions that required epidural analgesia during delivery, give birth prior to receiving their allocated intervention, or give birth by caesarean section, we decided to increase the sample size by 10% in all groups to a total of 890 participants.

In 2010, the study board experienced that in 2009 the general frequency of epidural analgesia in primiparas giving birth at Aarhus University Hospital Skejby had decreased to 34%.Therefore it was decided to adjust the sample size according to this new information.

When the sample size was adjusted we maintained the same sample ratios between the groups and hypothesized that the observed frequency of epidural analgesia would be 22 % in the intervention group, 30 % in the placebo effect group and 32 % in the placebo group. To obtain a power of 80 % (α 0.05 (two sided)) in detecting a difference of 8 percentage points (RR 0.73) between the intervention and the active comparator group in the use of epidural analgesia and a difference of 10 percentage points (RR 0.68) between the intervention and the control group we should include 446 participants in the hypnosis group, 446 participants in the active comparator group and 226 participants in the control group, in total 1097 participants. Again, we further increased the sample size with an extra 10% to account for those women that would not be able to comply with their allocated treatment because of obstetric conditions and reached a sample size in total of 1208.

Analyses will primarily be performed as "intended to treat". Secondary analyses according to "as treated" and preplanned subgroup analysis will also be performed.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1222 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	The Effect of Mental Training on Childbirth Measured on Pain Experience and Other Birth Outcomes
Study Start Date :	April 2009
Actual Primary Completion Date :	August 2011
Actual Study Completion Date :	March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: antenatal classes in self hypnosis 3 antenatal classes in self hypnosis. 3 audio compact discs for homework in self hypnosis and 1 audio compact disc for birth	Behavioral: Self hypnosis 3 antenatal classes of 1 hour. 3 audio compact discs for reenforcement. 1 audio compact discs for support at birth Other Name: Hypnosis
Active Comparator: relaxation and awareness 3 antenatal classes including training in relaxation methods and mindfulness.3 audio compact discs for homework and 1 for birth.	Behavioral: Self hypnosis 3 antenatal classes of 1 hour. 3 audio compact discs for reenforcement. 1 audio compact discs for support at birth Other Name: Hypnosis
Control Only receive ordinary antenatal care and no additional interventions	Behavioral: Self hypnosis 3 antenatal classes of 1 hour. 3 audio compact discs for reenforcement. 1 audio compact discs for support at birth Other Name: Hypnosis

Outcome Measures

Primary Outcome Measures :

The use of epidural analgesia during birth [ Time Frame: At birth ]

Secondary Outcome Measures :

Length of birth [ Time Frame: At Birth ]
Birth progression at arrival at birth department [ Time Frame: arrival at birth department ]
Birth experience (pain, control, anxiety) [ Time Frame: 6 weeks p.p. ]
Medical interventions during birth including mode of delivery [ Time Frame: At birth ]
Hemorrhage during birth [ Time Frame: At birth ]
Saliva cortisol profile at birth and 6 weeks p.p. [ Time Frame: at birth and 6 weeks p.p. ]
Infection during birth and the first 6 weeks p.p. (mother and child) [ Time Frame: at birth and during the first 6 weeks p.p. ]
Postnatal depression [ Time Frame: 6 weeks and 6 month p.p. ]
Breastfeeding duration [ Time Frame: 6 weeks and 6 month p.p. ]
Childs condition and wellbeing at birth and 6 months later [ Time Frame: At birth and 6 month p.p. ]
Future mode of delivery [ Time Frame: 6 month p.p. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Singleton pregnancy
Nulliparous
Planning a normal and vaginal birth

Exclusion Criteria:

Poor understanding of Danish
Psychological and psychiatric problems
Medical disorders

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914082

Locations

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Denmark
Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby
Aarhus, Aarhus N, Denmark, 8200

Sponsors and Collaborators

University of Aarhus

Aarhus University Hospital

Investigators

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Principal Investigator:	Anette Werner, Ms of healthsc, Ph.Dstudent	Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby
Study Chair:	Niels Uldbjerg, MD, Professor	Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby
Study Chair:	Ellen A Nøhr, ass. professor	University of Aarhus, Department of Epidemiology
Study Chair:	Bobby Zachariae, MD, Professor	Aarhus University Hospital, Psychooncology Research Unit
Study Chair:	Aase M Hansen, senior researcher	National Research Center for the Working Enviroment

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Werner A, Uldbjerg N, Zachariae R, Wu CS, Nohr EA. Antenatal hypnosis training and childbirth experience: a randomized controlled trial. Birth. 2013 Dec;40(4):272-80. doi: 10.1111/birt.12071.

Werner A, Uldbjerg N, Zachariae R, Nohr EA. Effect of self-hypnosis on duration of labor and maternal and neonatal outcomes: a randomized controlled trial. Acta Obstet Gynecol Scand. 2013 Jul;92(7):816-23. doi: 10.1111/aogs.12141. Epub 2013 Apr 22.

Werner A, Uldbjerg N, Zachariae R, Rosen G, Nohr EA. Self-hypnosis for coping with labour pain: a randomised controlled trial. BJOG. 2013 Feb;120(3):346-53. doi: 10.1111/1471-0528.12087. Epub 2012 Nov 27.

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Responsible Party:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00914082
Other Study ID Numbers:	M-20080200
First Posted:	June 4, 2009 Key Record Dates
Last Update Posted:	March 18, 2013
Last Verified:	March 2013

Keywords provided by University of Aarhus:


Self hypnosis Hypnosis mental training antenatal training	pregnancy pain control Childbirth Analgesia

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