Hypnosis Antenatal Training for Childbirth (HATCh): a Randomised Controlled Trial

NCT00282204 | Completed Phase 2 DMC

• 1 other identifier: ACTRN012605000018617
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 1

Brief Summary

Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy.

Conditions

Pregnancy; Labor

Keywords

Hypnosis; Hypnotherapy; Childbirth; Analgesia

Outcome Measures

Primary Outcomes (1)

• The use of pharmacological analgesia during labour and childbirth will be collected from the birth register where all analgesia is documented by the attending midwife

  Within 24 hours of the birth

Secondary Outcomes (13)

• 1. Maternal rating of the overall pain experienced during labour and childbirth

  Usually within 48 hours or before discharge from hospital

• 2. Mode of delivery

  Within 24 hours of the birth

• 3. Use of oxytocics

  Within 24 hours of the birth

• 4. Postnatal depression

  At 6 weeks and 6 months postnatal

• 5. Maternal anxiety

  At 6 weeks and 6 months postnatal

Study Arms (3)

Control

NO INTERVENTION

Usual care control

Hypnosis + CD

EXPERIMENTAL

Hypnosis plus audio cd on hypnosis

Behavioral: antenatal hypnosis + audio compact disc on hypnosis

Audio CD on Hypnosis

ACTIVE COMPARATOR

Audio CD on hypnosis sessions weekly on three occasions after 34 weeks gestation

Behavioral: Audio compact disc on hypnosis

Interventions

antenatal hypnosis + audio compact disc on hypnosis BEHAVIORAL

Hypnosis + CD

Audio compact disc on hypnosis BEHAVIORAL

Audio CD on Hypnosis

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• women \> 34 \< 39 weeks gestation; singleton, viable fetus, vertex presentation, who are not in active labour (active labour is defined as cervical effacement and dilatation associated with regular uterine contractions) and who are planning a vaginal birth.

You may not qualify if:

• Previous hypnosis preparation for childbirth;
• poor understanding of English requiring translator;
• women who are already enrolled in another pregnancy trial where analgesia requirements are an outcome measure;
• active psychological or psychiatric problems such as: active depression requiring treatment by a psychiatrist;
• schizophrenia;
• prior psychosis;
• severe intellectual disability.
• Women with pain caused by specific pathological entities such as: congenital neuromuscular disorders; spina bifida; metastatic disease; osteoporosis; rheumatoid arthritis; fractures,are also excluded

Sponsors & Collaborators

• Women's and Children's Hospital, Australia: lead

Study Sites (1)

Women's and Children's Hospital

Adelaide, South Australia, 5006, Australia

Location

Related Publications (1)

• Cyna AM, Andrew MI, Robinson JS, Crowther CA, Baghurst P, Turnbull D, Wicks G, Whittle C. Hypnosis Antenatal Training for Childbirth (HATCh): a randomised controlled trial [NCT00282204]. BMC Pregnancy Childbirth. 2006 Mar 5;6:5. doi: 10.1186/1471-2393-6-5.

  PMID: 16515709 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

• Marion I Andrew, FANZCA

  Women's and Children's Hospital, Australia

  PRINCIPAL INVESTIGATOR

• Allan M Cyna, FRCA

  Women's and Children's Hospital, Australia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: December 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 29, 2012

Record last verified: 2010-12

Locations

AU (1)