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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:

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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 6, 2021
Est. primary completion date March 6, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 42 Years
Eligibility 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 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)

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 — View Citation

Göncü Serhatlioglu S, Karahan N, Hollins Martin CJ, Martin CR. Construct and content validity of the Turkish Birth Satisfaction Scale - Revised (T-BSS-R). J Reprod Infant Psychol. 2018 Jul;36(3):235-245. doi: 10.1080/02646838.2018.1443322. Epub 2018 Mar 19. — View Citation

Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2013 Jul 15;7:CD003766. doi: 10.1002/14651858.CD003766.pub5. Review. Update in: Cochrane Database Syst Rev. 2017 Jul 06;7:CD003766. — View Citation

Hollins Martin CJ, Martin CR. Development and psychometric properties of the Birth Satisfaction Scale-Revised (BSS-R). Midwifery. 2014 Jun;30(6):610-9. doi: 10.1016/j.midw.2013.10.006. Epub 2013 Oct 24. — View Citation

Kobayashi S, Hanada N, Matsuzaki M, Takehara K, Ota E, Sasaki H, Nagata C, Mori R. Assessment and support during early labour for improving birth outcomes. Cochrane Database Syst Rev. 2017 Apr 20;4:CD011516. doi: 10.1002/14651858.CD011516.pub2. Review. — View Citation

Korukcu O, Kukulu K, Firat MZ. The reliability and validity of the Turkish version of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) with pregnant women. J Psychiatr Ment Health Nurs. 2012 Apr;19(3):193-202. doi: 10.1111/j.1365-2850.2011.01694.x. Epub 2012 Jan 20. — View Citation

Phillips-Moore J. HypnoBirthing. Aust J Holist Nurs. 2005 Apr;12(1):41-2. — View Citation

Saisto T, Halmesmäki E. Fear of childbirth: a neglected dilemma. Acta Obstet Gynecol Scand. 2003 Mar;82(3):201-8. Review. — View Citation

Serçekus P, Okumus H. Fears associated with childbirth among nulliparous women in Turkey. Midwifery. 2009 Apr;25(2):155-62. Epub 2007 Jun 27. — View Citation

Varner CA. Comparison of the Bradley Method and HypnoBirthing Childbirth Education Classes. J Perinat Educ. 2015;24(2):128-36. doi: 10.1891/1946-6560.24.2.128. — View 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. — View Citation

* Note: There are 11 references in allClick here to view all references

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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