Mental Training and Childbirth - Full Text View

Sponsors and Collaborators:	University of Aarhus Aarhus University Hospital
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00914082

Purpose

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	Intervention
Childbirth Pain	Behavioral: Self hypnosis

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Caregiver, Investigator), Active Control, Parallel Assignment
Official Title:	The Effect of Mental Training on Childbirth Measured on Pain Experience and Other Birth Outcomes

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

The use of epidural analgesia during birth [ Time Frame: At birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Length of birth [ Time Frame: At Birth ] [ Designated as safety issue: No ]
Birth progression at arrival at birth department [ Time Frame: arrival at birth department ] [ Designated as safety issue: No ]
Birth experience (pain, control, anxiety) [ Time Frame: 6 weeks p.p. ] [ Designated as safety issue: No ]
Medical interventions during birth including mode of delivery [ Time Frame: At birth ] [ Designated as safety issue: No ]
Hemorrhage during birth [ Time Frame: At birth ] [ Designated as safety issue: No ]
Saliva cortisol profile at birth and 6 weeks p.p. [ Time Frame: at birth and 6 weeks p.p. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
Postnatal depression [ Time Frame: 6 weeks and 6 month p.p. ] [ Designated as safety issue: No ]
Breastfeeding duration [ Time Frame: 6 weeks and 6 month p.p. ] [ Designated as safety issue: No ]
Childs condition and wellbeing at birth and 6 months later [ Time Frame: At birth and 6 month p.p. ] [ Designated as safety issue: No ]
Future mode of delivery [ Time Frame: 6 month p.p. ] [ Designated as safety issue: No ]

Estimated Enrollment:	890
Study Start Date:	April 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
antenatal classes in self hypnosis: Experimental 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
relaxation and awareness: Active Comparator 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
Control: No Intervention 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

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914082

Contacts

Contact: Anette Werner, Ms of healthsc, Ph.D student	+45 40195755	anette.werner@soci.au.dk
Contact: Niels Uldbjerg, MD, Professor	+45 89496315	uldbjerg@ki.au.dk

Locations

Denmark, Aarhus N
Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby	Recruiting
Aarhus, Aarhus N, Denmark, 8200
Contact: Anette Werner, Ms of healthscience, Ph.D stud +45 8949 6383 anette.werner@soci.au.dk
Principal Investigator: Anette Werner, Ms of healthsc, Ph.D student

Sponsors and Collaborators

University of Aarhus

Aarhus University Hospital

Investigators

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

Additional Information:

Project homepage This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Department of Obstetrics and Gynecology, Aarhus University Hospital, Skejby, Denmark. ( Niels Uldbjerg, MD, Professor )
Study ID Numbers:	M-20080200
Study First Received:	June 2, 2009
Last Updated:	August 24, 2009
ClinicalTrials.gov Identifier:	NCT00914082 History of Changes
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:

Self hypnosis
Hypnosis
mental training
antenatal training

pregnancy
pain control
Childbirth
Analgesia

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on September 03, 2009