Mental Training and Childbirth

March 15, 2013 updated by: University of Aarhus

The Effect of Mental Training on Childbirth Measured on Pain Experience and Other Birth Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1222

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus N
      • Aarhus, Aarhus N, Denmark, 8200
        • Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Hypnosis
Other: 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 Names:
  • Hypnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The use of epidural analgesia during birth
Time Frame: At birth
At birth

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of birth
Time Frame: At Birth
At Birth
Birth progression at arrival at birth department
Time Frame: arrival at birth department
arrival at birth department
Birth experience (pain, control, anxiety)
Time Frame: 6 weeks p.p.
6 weeks p.p.
Medical interventions during birth including mode of delivery
Time Frame: At birth
At birth
Hemorrhage during birth
Time Frame: At birth
At birth
Saliva cortisol profile at birth and 6 weeks p.p.
Time Frame: at birth and 6 weeks p.p.
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.
at birth and during the first 6 weeks p.p.
Postnatal depression
Time Frame: 6 weeks and 6 month p.p.
6 weeks and 6 month p.p.
Breastfeeding duration
Time Frame: 6 weeks and 6 month p.p.
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.
At birth and 6 month p.p.
Future mode of delivery
Time Frame: 6 month p.p.
6 month p.p.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

March 18, 2013

Last Update Submitted That Met QC Criteria

March 15, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M-20080200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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