Effect of Hypnobirthing Training on Fear, Pain, Satisfaction and, Birth Outcomes

May 2, 2021 updated by: Gonca Buran, Aydin Adnan Menderes University

Effect of Hypnobirthing Training on Fear, Pain, Satisfaction Related to Birth and, Birth Outcomes: A Randomized Controlled Trial

Background and Purpose: Hypnobirthing is childbirth education model. This model aims for women to have a painless, calm and more comfortable birth. In this study is aimed to determine the effect of Hypnobirthing training on fear of childbirth, birth pain, birth satisfaction and birth outcomes.

Materials and Methods: This randomized controlled experimental study was performed in Maternity Hospital (Bursa, Turkey) . The minimum required sample size to be included in the study will calculated with G* power. The simple randomization method was use in the assignment of healthy and nulliparous pregnant women at 28-32 weeks of gestation to the groups. The assignment of the participants to the experimental group or control group was carried out with a computer-aided program. The nulliparous women was divided into two groups as the control group contained women who received the hospital's usual care, and the experimental group contained women who received the hypnobirthing training intervention. The fear of birth was measured with the Wijma Birth Expectancy/Experience Scale A and B (W-DEQ); labor pain was measured with Visual Analogue Scale (VAS); birth satisfaction was measured with Short Form of Birth Satisfaction Scale (BSS-R); birth outcomes will measure with postpartum Information form. The Statistical Package for the Social Sciences program (version 25.00) was use in data analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fear of childbirth and labor pain are big problem that needs to be resolved as a priority since this situation continues by starting the vicious cycle of fear-anxiety-pain during childbirth. The persistence of the cycle increases the fear and pain related to childbirth, and thus delivery may result in emergency cesarean or elective cesarean. According to the data of Economic Development and Cooperation (OECD), the cesarean section rate in Turkey is 53.1% and so higher than the recommended rate, even Turkey has the highest rate among the OECD countries . High cesarean rates are an important problem that negatively affects maternal and infant health and increase health expenditures and costs. Therefore, the pregnant women education programs aimed at lowering the rate of cesarean section are still important in Turkey as in other countries. While the childbirth education programs for pregnant women are not widely practiced in Turkey, the Turkish Ministry of Health (TMOH) started to provide childbirth preparation courses to reduce the rate of cesarean section in recent years. In the circular issued by the TMOH in 2018, it was determined that these programs should be managed by physicians, obstetrics nurses, and midwives. Nurses are actively involved in pregnancy training programs where different methods are applied in Turkey as well as all over the world. The most common training methods applied in other countries are Lamaze Method, Bradly Method, and Hypnobirthing.

Hypnobirthing is a childbirth preparation method that aims to prepare pregnant women for delivery mentally and physically and to give birth in a less painful, conscious, and fear-free way. This method was developed based on the fear-stress-pain cycle. The persistence of this cycle exacerbates stress and pain, prolongs the birth period, and negatively affects the success, way, preference, course, and satisfaction of the birth. Thus, the birth does not proceed properly and results in an emergency or elective cesarean section. Hypnobirthing can prepare women for childbirth to eliminate all these negativities.

Hypnobirthing training can be considered as a new technique for Turkey and therefore we conducted this study to determine its effects on the pain, fear, satisfaction related to childbirth and childbirth outcomes.

Study Type

Interventional

Enrollment (Actual)

80

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

  • Turkey
      • Bursa, Turkey, 16059
        • Gonca Buran

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 to 42 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Primiparas
  • Ages between 18-42
  • In gestational week 28-32
  • Being literate in Turkish
  • Pregnant with a single child
  • Minimum a primary school graduate (since the questionnaires would be filled out by self-reporting)

Exclusion Criteria:

  • High-risk pregnancy (on the basis of the criteria of the Ministry of Health)
  • Attended other prenatal training sessions (pregnancy pilates and yoga)
  • High-risk pregnancy

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standart care
Standart care group will leave in the hospital's usual care and no intervention will be applied.
Other: Standart care
This group will leave in the hospital's usual care and no intervention will be applied.
Experimental: Hypnobirthing group
Hypnobirthig training intervention will be applied to the Hypnobirthing group for 4 weeks and 3 hours a week and usual care will be provided by healthcare professionals.
Behavioral: Hypnobirthig training

Hypnobirthing training of the Hypnobirthing group will carry out with its partner. Hypnobirthig training will be given in small groups of 5 or 6 couples for 4 weeks and 3 hours a week. In addition, the usual care will be provided by healthcare professionals to this group.

Breathing, relaxation exercises, birth stories and birth videos will be used to reduce fears of chlildbirt women.

Deepening and endorphin massage techniques will be given for labor pain. After the endorphin massage technique will be applied individually by the researcher, it will be applied by the couples and they will ask for repeating all exercises at home.

In the last week of the training, there will be a birth rehearsal with Hynobirthing methods with the partners.

The second meeting will take place when labor begins and after labor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preinterventional Scores on the W-DEQ-A (the minimum values:0, maximum:165)
Time Frame: When the control and experimental groups were Enrollment in the study
Distribution of the scores of pregnant women on the W-DEQ-A before the intervention to the experimental and control groups. Higher scores are worse outcome.
When the control and experimental groups were Enrollment in the study
The VAS scores of the experimental and control groups (the minimum values:0, maximum=10)
Time Frame: in the process of labor (the first stage of labor: latent, active and transitional phases )
Distribution of the women on the VAS in the first stage of labor according to the experimental and control groups. Higher scores are worse outcome.
in the process of labor (the first stage of labor: latent, active and transitional phases )
W-DEQ-B Scores (the minimum values:0, maximum:160)
Time Frame: within eight hours after birth
Distribution of the scores of the women on the whole W-DEQ-B according to the control and experimental groups. Higher scores are worse outcome.
within eight hours after birth
The chilbirth scores of the experimental and control groups (questionnaire)
Time Frame: within eight hours after birth
Information about the childbirth of the experimental and control groups ( childbirth position, Intervention at birth, way of delivery, duration of delivery)
within eight hours after birth
BSS-R scores of experimental and control groups (the minimum values:0, maximum:40) • Low level of satisfaction ˂13 points, • Medium satisfaction level 14-27 points, • High satisfaction level ≥28
Time Frame: within eight hours after birth
Postpartum scores of the control and experimental groups on the BSS-R. Higher scores are better outcome.
within eight hours after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Women and baby interaction
Time Frame: within eight hours after birth
The first skin to skin contact time and the first breastfeeding time of the women in the control and experimental groups
within eight hours after birth

Collaborators and Investigators

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

Sponsor

Aydin Adnan Menderes University

Investigators

  • Study Director: Hilmiye Aksu, Professor, Adnan Menderes University

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 (Actual)

May 4, 2019

Primary Completion (Actual)

March 6, 2020

Study Completion (Actual)

March 6, 2021

Study Registration Dates

First Submitted

April 5, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 2, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/GB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

there is no a plan to make individual participant data (IPD) available to other researcher on Clinical Trails.cov.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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