Mental Training and Childbirth

NCT00914082 | Completed

• 1 other identifier: M-20080200
• Study Type: interventional
• Target: 1,222
• Locations: 1 country
• Sites: 1

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.

Conditions

Childbirth; Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The use of epidural analgesia during birth

  At birth

Secondary Outcomes (11)

• Length of birth

  At Birth

• Birth progression at arrival at birth department

  arrival at birth department

• Birth experience (pain, control, anxiety)

  6 weeks p.p.

• Medical interventions during birth including mode of delivery

  At birth

• Hemorrhage during birth

  At birth

Study Arms (3)

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

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

Control

OTHER

Only receive ordinary antenatal care and no additional interventions

Behavioral: Self hypnosis

Interventions

Self hypnosis BEHAVIORAL

3 antenatal classes of 1 hour. 3 audio compact discs for reenforcement. 1 audio compact discs for support at birth

Also known as: Hypnosis

Control; antenatal classes in self hypnosis; relaxation and awareness

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancy
• Nulliparous
• Planning a normal and vaginal birth

You may not qualify if:

• Poor understanding of Danish
• Psychological and psychiatric problems
• Medical disorders

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby

Aarhus, Aarhus N, 8200, Denmark

Location

Related Publications (4)

• O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.

  PMID: 34231203 DERIVED

• 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.

  PMID: 24344708 DERIVED

• 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.

  PMID: 23550694 DERIVED

• 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.

  PMID: 23190251 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anette Werner, Ms of healthsc, Ph.Dstudent

  Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 4, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: March 1, 2013
• Last Updated: March 18, 2013

Record last verified: 2013-03

Locations

DK (1)