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Mental Training and Childbirth

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00914082
First received: June 2, 2009
Last updated: March 15, 2013
Last verified: March 2013
  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 Blind (Caregiver, Investigator)
Primary Purpose: Treatment
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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by University of Aarhus

Additional 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
Study First Received: June 2, 2009
Last Updated: March 15, 2013
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

ClinicalTrials.gov processed this record on November 25, 2014