Pregnancy Related Clinical Trial
Official title:
Effect of Hypnobirthing Training on Fear, Pain, Satisfaction Related to Birth and, Birth Outcomes: A Randomized Controlled Trial
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 |
Verified date | May 2021 |
Source | Aydin Adnan Menderes University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Gonca Buran | Bursa |
Lead Sponsor | Collaborator |
---|---|
Aydin Adnan Menderes University |
Turkey,
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 all — Click here to view all references
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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