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Mental Training and Childbirth

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00914082
First Posted: June 4, 2009
Last Update Posted: March 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
  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: 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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

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. ]

Enrollment: 1222
Study Start Date: April 2009
Study Completion Date: March 2013
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00914082     History of Changes
Other Study ID Numbers: M-20080200
First Submitted: June 2, 2009
First Posted: June 4, 2009
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