NCT04838340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

10 months

First QC Date

April 5, 2021

Last Update Submit

May 2, 2021

Conditions

Keywords

ChildbirthLabor PainFear of childbirthSatisfactionPrenatal educationHypnobirthing

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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 )

  • 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

  • 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

  • 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 Outcomes (1)

  • Women and baby interaction

    within eight hours after birth

Study Arms (2)

Standart care

ACTIVE COMPARATOR

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

Other: Standart care

Hypnobirthing group

EXPERIMENTAL

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

Interventions

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

Standart care

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.

Hypnobirthing group

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gonca Buran

Bursa, 16059, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

    PMID: 26957896BACKGROUND
  • 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.

    PMID: 9638601BACKGROUND
  • Saisto T, Halmesmaki E. Fear of childbirth: a neglected dilemma. Acta Obstet Gynecol Scand. 2003 Mar;82(3):201-8.

    PMID: 12694113BACKGROUND
  • 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.

    PMID: 22260727BACKGROUND
  • 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.

    PMID: 24252712BACKGROUND
  • Goncu 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.

    PMID: 29553295BACKGROUND
  • Sercekus P, Okumus H. Fears associated with childbirth among nulliparous women in Turkey. Midwifery. 2009 Apr;25(2):155-62. doi: 10.1016/j.midw.2007.02.005. Epub 2007 Jun 27.

    PMID: 17600599BACKGROUND
  • 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.

  • Phillips-Moore J. HypnoBirthing. Aust J Holist Nurs. 2005 Apr;12(1):41-2. No abstract available.

  • 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(4):CD011516. doi: 10.1002/14651858.CD011516.pub2.

  • 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.

MeSH Terms

Conditions

Labor PainPersonal Satisfaction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Gonca Buran, PhD

    Uludag Üniversity

    PRINCIPAL INVESTIGATOR
  • Hilmiye Aksu, Professor

    Adnan Menderes Üniversity

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 9, 2021

Study Start

May 4, 2019

Primary Completion

March 6, 2020

Study Completion

March 6, 2021

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

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

Locations