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

Primary Purpose

Prenatal Education, Pregnancy Related, Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Standart care
Hypnobirthig training
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prenatal Education focused on measuring Childbirth, Labor Pain, Fear of childbirth, Satisfaction, Prenatal education, Hypnobirthing

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Gonca Buran

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standart care

Hypnobirthing group

Arm Description

Standart care group will leave in the hospital's usual care and no intervention will be applied.

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.

Outcomes

Primary Outcome Measures

Preinterventional Scores on the W-DEQ-A (the minimum values:0, maximum:165)
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.
The VAS scores of the experimental and control groups (the minimum values:0, maximum=10)
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.
W-DEQ-B Scores (the minimum values:0, maximum:160)
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.
The chilbirth scores of the experimental and control groups (questionnaire)
Information about the childbirth of the experimental and control groups ( childbirth position, Intervention at birth, way of delivery, duration of delivery)
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
Postpartum scores of the control and experimental groups on the BSS-R. Higher scores are better outcome.

Secondary Outcome Measures

Women and baby interaction
The first skin to skin contact time and the first breastfeeding time of the women in the control and experimental groups

Full Information

First Posted
April 5, 2021
Last Updated
May 2, 2021
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT04838340
Brief Title
Effect of Hypnobirthing Training on Fear, Pain, Satisfaction and, Birth Outcomes
Official Title
Effect of Hypnobirthing Training on Fear, Pain, Satisfaction Related to Birth and, Birth Outcomes: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 4, 2019 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prenatal Education, Pregnancy Related, Labor Pain
Keywords
Childbirth, Labor Pain, Fear of childbirth, Satisfaction, Prenatal education, Hypnobirthing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standart care
Arm Type
Active Comparator
Arm Description
Standart care group will leave in the hospital's usual care and no intervention will be applied.
Arm Title
Hypnobirthing group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standart care
Intervention Description
This group will leave in the hospital's usual care and no intervention will be applied.
Intervention Type
Behavioral
Intervention Name(s)
Hypnobirthig training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preinterventional Scores on the W-DEQ-A (the minimum values:0, maximum:165)
Description
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.
Time Frame
When the control and experimental groups were Enrollment in the study
Title
The VAS scores of the experimental and control groups (the minimum values:0, maximum=10)
Description
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.
Time Frame
in the process of labor (the first stage of labor: latent, active and transitional phases )
Title
W-DEQ-B Scores (the minimum values:0, maximum:160)
Description
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.
Time Frame
within eight hours after birth
Title
The chilbirth scores of the experimental and control groups (questionnaire)
Description
Information about the childbirth of the experimental and control groups ( childbirth position, Intervention at birth, way of delivery, duration of delivery)
Time Frame
within eight hours after birth
Title
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
Description
Postpartum scores of the control and experimental groups on the BSS-R. Higher scores are better outcome.
Time Frame
within eight hours after birth
Secondary Outcome Measure Information:
Title
Women and baby interaction
Description
The first skin to skin contact time and the first breastfeeding time of the women in the control and experimental groups
Time Frame
within eight hours after birth

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gonca Buran, PhD
Organizational Affiliation
Uludag Üniversity
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hilmiye Aksu, Professor
Organizational Affiliation
Adnan Menderes Üniversity
Official's Role
Study Director
Facility Information:
Facility Name
Gonca Buran
City
Bursa
ZIP/Postal Code
16059
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
there is no a plan to make individual participant data (IPD) available to other researcher on Clinical Trails.cov.
Citations:
PubMed Identifier
26957896
Citation
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Results Reference
background
PubMed Identifier
9638601
Citation
Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998 Jun;19(2):84-97. doi: 10.3109/01674829809048501.
Results Reference
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PubMed Identifier
12694113
Citation
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PubMed Identifier
22260727
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
background
PubMed Identifier
29553295
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
Fenwick J, Toohill J, Gamble J, Creedy DK, Buist A, Turkstra E, Sneddon A, Scuffham PA, Ryding EL. Effects of a midwife psycho-education intervention to reduce childbirth fear on women's birth outcomes and postpartum psychological wellbeing. BMC Pregnancy Childbirth. 2015 Oct 30;15:284. doi: 10.1186/s12884-015-0721-y.
Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
result

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

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