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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04838340
Other study ID # 01/GB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 4, 2019
Est. completion date March 6, 2021

Study information

Verified date May 2021
Source Aydin Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Gonca Buran Bursa

Sponsors (1)

Lead Sponsor Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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. When the control and experimental groups were Enrollment in the study
Primary 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. in the process of labor (the first stage of labor: latent, active and transitional phases )
Primary 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. within eight hours after birth
Primary 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) within eight hours after birth
Primary 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. within eight hours after birth
Secondary 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 within eight hours after birth
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