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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • Center
      • Giresun, Center, Turkey, 28200
        • Giresun Gynecology and Children's Diseases Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HypnoBirthing training and oxytocin massage group
Pregnant women who received HypnoBirthing training and oxytocin massage constituted the experimental group.
Other: HypnoBirthing training and oxytocin massage 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
five weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
5 weeks
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Giresun University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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