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Mental Training and Childbirth

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ClinicalTrials.gov Identifier: NCT00914082
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : March 18, 2013
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE June 2, 2009
First Posted Date  ICMJE June 4, 2009
Last Update Posted Date March 18, 2013
Study Start Date  ICMJE April 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
The use of epidural analgesia during birth [ Time Frame: At birth ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mental Training and Childbirth
Official Title  ICMJE The Effect of Mental Training on Childbirth Measured on Pain Experience and Other Birth Outcomes
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.

Detailed Description

Background:

Experiencing labour pain is a challenge to the parturient woman and can possibly cause a traumatic birth experience, post traumatic stress syndrome, post partum depression, caesarean section or refraining from having more children.

Pharmacological pain relief methods to relieve birth pain are limited and often associated with side effects. Investigating new methods without adverse effects to relieve labour pain is therefore important.

Several studies indicate that a mental trainings method, self-hypnosis, has a positive impact on labour pain and several other birth outcomes. However, many of these studies were based on observational data with a limited amount of participants that may be prone to bias and confounding.

Aim:

The aim of this study is to examine the effect of a short antenatal course in self hypnosis on the use of epidural analgesia during childbirth.

Method:

The study is designed as an interventional single center study taking place at one of the largest birth departments in Denmark. It is a randomised, controlled, single blinded trial using a 3 arm group design.

The participants will be randomised by a voice respond program. The intervention group receives 3 antenatal classes in self hypnosis taught by midwives with qualified training in hypnosis. The course includes audio compact discs for homework in self hypnosis.

The active comparator group also receives 3 antenatal classes. The program is taught by the same midwives as in the intervention group and includes a mixture of training in different relaxation methods and mindfulness. This course also includes audio compact discs for homework.

The control group will only receive ordinary antenatal care and no additional interventions.

The data collection will be based on questionnaires, register data, medical records and biological material.

The endpoints are:

Primary:

  • The use of epidural analgesia during birth

Secondary:

  • Length of birth
  • Birth progression at arrival at birth department
  • Birth experience (pain, control, anxiety)
  • Medical interventions during birth including mode of delivery
  • Hemorrhage during birth
  • Saliva cortisol profile at birth and 6 weeks p.p.
  • Infection during birth and the first 6 weeks p.p. (mother and child)
  • Postnatal depression
  • Breastfeeding duration
  • Child's condition and wellbeing at birth and 6 months later
  • Future mode of delivery

At the start of the study, we performed our power calculations based on the fact that 44% of all primiparas at Aarhus University Hospital Skejby in 2007 had received epidural analgesia. We hypothesized that the observed frequency of epidural analgesia would be 25 % in the intervention group, 35 % in the placebo effect group and 40 % in the placebo group.

According to these power calculations, we should include 328 participants in the hypnosis group, 328 participants in the active comparator group and 152 participants in the control group to obtain a power of 80 % (α 0.05 (two sided)) in detecting a difference of 5 percentage points (relative risk (RR) 0.71) between the intervention and the active comparator group. By including 152 participants in the control group we would have a larger power to detect a difference of 15 percentage points (RR 0.63) in the use of epidural analgesia between the intervention and the control group.

Because we expected that some participants would develop medical conditions that required epidural analgesia during delivery, give birth prior to receiving their allocated intervention, or give birth by caesarean section, we decided to increase the sample size by 10% in all groups to a total of 890 participants.

In 2010, the study board experienced that in 2009 the general frequency of epidural analgesia in primiparas giving birth at Aarhus University Hospital Skejby had decreased to 34%.Therefore it was decided to adjust the sample size according to this new information.

When the sample size was adjusted we maintained the same sample ratios between the groups and hypothesized that the observed frequency of epidural analgesia would be 22 % in the intervention group, 30 % in the placebo effect group and 32 % in the placebo group. To obtain a power of 80 % (α 0.05 (two sided)) in detecting a difference of 8 percentage points (RR 0.73) between the intervention and the active comparator group in the use of epidural analgesia and a difference of 10 percentage points (RR 0.68) between the intervention and the control group we should include 446 participants in the hypnosis group, 446 participants in the active comparator group and 226 participants in the control group, in total 1097 participants. Again, we further increased the sample size with an extra 10% to account for those women that would not be able to comply with their allocated treatment because of obstetric conditions and reached a sample size in total of 1208.

Analyses will primarily be performed as "intended to treat". Secondary analyses according to "as treated" and preplanned subgroup analysis will also be performed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Childbirth
  • Pain
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Self 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.
    Intervention: Behavioral: Self hypnosis
  • Control
    Only receive ordinary antenatal care and no additional interventions
    Intervention: Behavioral: Self hypnosis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2012)
1222
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2009)
890
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Poor understanding of Danish
  • Psychological and psychiatric problems
  • Medical disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00914082
Other Study ID Numbers  ICMJE M-20080200
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Aarhus University Hospital
Investigators  ICMJE
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
PRS Account University of Aarhus
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP