- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06325839
Effects of HypnoBirthing Training and Oxytocin Massage in Primiparous Pregnants
March 16, 2024 updated by: ezgi.sahin, Giresun University
Effects of HypnoBirthing Training and Oxytocin Massage on Delivery and Postpartum Period in Primiparous Pregnants: A Randomized Controlled Study
This study was conducted to determine the effects of hypnobirthing training and oxytocin massage on birth and postpartum period in primiparous pregnant women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hypnobirthing is a birth philosophy and method that prepares women physically and psychologically for giving birth.
It is important to break the fear-tension-pain cycle in HypnoBirthing training.
Because the continuity of the cycle increases the pain related to birth, and as the pain increases, the fear increases.
In this case, the duration of labor is prolonged, birth success, shape, preference, course and satisfaction are negatively affected.
Therefore, this training helps to reduce pain and fear related to labor and increase labor satisfaction.
Similarly, it has been determined in the literature that oxytocin (back massage) massage during pregnancy increases uterine contractions, reduces labor pain and duration of labor, accelerates postpartum uterine involution, significantly increases the amount of breast milk, and increases mother-baby attachment.
The pregnant education role of the health professional is an effective factor that shapes the birth experience of pregnant women.
For this purpose, health professionals in the world and in our country are actively involved in pregnancy education programs in which different methods are applied.
The most common ones are Lamaze, Bradly and HypnoBirthing.
These trainings also serve to reduce pain and fear related to childbirth, increase labor and postpartum satisfaction, and meet the need for professional support and education of pregnant women.
When the studies on HypnoBirthing training and oxytocin massage are examined in the literature, it is noteworthy that there is a very limited number of studies.
Therefore, there is a need for well-designed randomized controlled trials that can create a level of evidence for HypnoBirthing training and oxytocin massage.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Center
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Giresun, Center, Turkey, 28200
- Giresun Gynecology and Children's Diseases Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Pregnant women between the ages of 18 and 45,
- Able to communicate verbally,
- Being in the 36th week of pregnancy,
- Having a single fetus,
- Being nulliparous
Exclusion Criteria:
- Pregnant women at risk
- Multiparous pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HypnoBirthing training and oxytocin massage group
Pregnant women who received HypnoBirthing training and oxytocin massage constituted the experimental group.
|
HypnoBirthing training and oxytocin massage were applied for a total of 12 hours for 4 weeks with the experimental group.
|
No Intervention: The group without HypnoBirthing training and oxytocin massage
Pregnant women who did not receive HypnoBirthing training and oxytocin massage constituted the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wijma Birth Anticipation/Experience Scale A (W-DEQ-A)
Time Frame: five weeks
|
The WDEQ A is a six-point Likert-type scale consisting of 33 items, scored 0-5, with 0 being "completely" and 5 being "not at all".
The pregnant woman is asked to indicate a number between 0 and 5 that suits her.
W-DEQ-A scores were categorized into four subgroups.
These are women with a low degree of fear of childbirth (W-DEQ-A score ≤37), women with moderate fear of childbirth (W-DEQ-A score between 38-65), women with severe fear of childbirth (W-DEQ-A score 66-84) and women with clinical fear of childbirth (W-DEQ-A score ≥ 85).
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five weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wijma Birth Expectancy/Expectation Scale B (W-DEQ-B)
Time Frame: Five weeks
|
The scale consists of 33 items.
The responses in the scale are numbered from 0 to 5 and are in six-point Likert type.
0 means "completely" and 5 means "not at all".
The minimum score on the scale is 0, while the maximum score is 160.
As the score increases, the fear of childbirth experienced by women increases.
|
Five weeks
|
Postpartum Breastfeeding Self-Efficacy Scale - Short Form
Time Frame: 5 weeks
|
The scale consists of 14 items.
The scale is a 5-point Likert scale, ranging from never sure (1 point) to always sure (5 points).
The minimum score is 14 and the maximum score is 70.
The scale has no cut-off point and a higher score means higher breastfeeding self-efficacy.
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5 weeks
|
Mother-Infant Attachment Scale (MICS)
Time Frame: 5 weeks
|
This scale, consisting of 8 items, is designed to be applied from the first day after birth and allows the mother to express her feelings towards her baby with a single word.
It is a 4-point Likert scale.
Responses consisting of four options are scored between 0-3, the lowest score that can be obtained from the scale is 0 and the highest score is 24.
High scores indicate that mother-baby attachment is strong.
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5 weeks
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Birth satisfaction scale short form (BSS-SF)
Time Frame: 5 weeks
|
BSS-SF is a 10-item scale of 5-point Likert type.
The lowest score from the scale is "0" and the highest score is "40", and as the score obtained from the scale increases, the level of satisfaction increases.
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ezgi ŞAHİN, ph.D, Giresun University Faculty of Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Actual)
September 10, 2023
Study Completion (Actual)
September 10, 2023
Study Registration Dates
First Submitted
March 16, 2024
First Submitted That Met QC Criteria
March 16, 2024
First Posted (Actual)
March 22, 2024
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 16, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GRU-SBF-ES-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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