Clinical trial NCT00914082: Mental Training and Childbirth
Official title: The Effect of Mental Training on Childbirth Measured on Pain Experience and Other Birth Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childbirth
Pain
Keywords: Self hypnosis
Hypnosis
mental training
antenatal training
pregnancy
pain control
Childbirth
Analgesia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2009-06-04
Enrollment: 1222
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The use of epidural analgesia during birth
timeFrame: At birth
Secondary outcomes:
measure: Length of birth
timeFrame: At Birth
measure: Birth progression at arrival at birth department
timeFrame: arrival at birth department
measure: Birth experience (pain, control, anxiety)
timeFrame: 6 weeks p.p.
measure: Medical interventions during birth including mode of delivery
timeFrame: At birth
measure: Hemorrhage during birth
timeFrame: At birth
measure: Saliva cortisol profile at birth and 6 weeks p.p.
timeFrame: at birth and 6 weeks p.p.
measure: Infection during birth and the first 6 weeks p.p. (mother and child)
timeFrame: at birth and during the first 6 weeks p.p.
measure: Postnatal depression
timeFrame: 6 weeks and 6 month p.p.
measure: Breastfeeding duration
timeFrame: 6 weeks and 6 month p.p.
measure: Childs condition and wellbeing at birth and 6 months later
timeFrame: At birth and 6 month p.p.
measure: Future mode of delivery
timeFrame: 6 month p.p.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby
state: Aarhus N
Study officials:
affiliation: Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby
name: Anette Werner, Ms of healthsc, Ph.Dstudent
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby
name: Niels Uldbjerg, MD, Professor
role: STUDY_CHAIR
affiliation: University of Aarhus, Department of Epidemiology
name: Ellen A Nøhr, ass. professor
role: STUDY_CHAIR
affiliation: Aarhus University Hospital, Psychooncology Research Unit
name: Bobby Zachariae, MD, Professor
role: STUDY_CHAIR
affiliation: National Research Center for the Working Enviroment
name: Aase M Hansen, senior researcher
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.