NCT06325839

Brief Summary

This study was conducted to determine the effects of hypnobirthing training and oxytocin massage on birth and postpartum period in primiparous pregnant women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

March 16, 2024

Last Update Submit

March 16, 2024

Conditions

Keywords

PregnancyBirthoxytocinpostpartumhypno-birthing

Outcome Measures

Primary Outcomes (1)

  • Wijma Birth Anticipation/Experience Scale A (W-DEQ-A)

    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 Outcomes (4)

  • Wijma Birth Expectancy/Expectation Scale B (W-DEQ-B)

    Five weeks

  • Postpartum Breastfeeding Self-Efficacy Scale - Short Form

    5 weeks

  • Mother-Infant Attachment Scale (MICS)

    5 weeks

  • Birth satisfaction scale short form (BSS-SF)

    5 weeks

Study Arms (2)

HypnoBirthing training and oxytocin massage group

EXPERIMENTAL

Pregnant women who received HypnoBirthing training and oxytocin massage constituted the experimental group.

Other: HypnoBirthing training and oxytocin massage group

The group without HypnoBirthing training and oxytocin massage

NO INTERVENTION

Pregnant women who did not receive HypnoBirthing training and oxytocin massage constituted the control group.

Interventions

HypnoBirthing training and oxytocin massage were applied for a total of 12 hours for 4 weeks with the experimental group.

HypnoBirthing training and oxytocin massage group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant women at risk
  • Multiparous pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giresun Gynecology and Children's Diseases Hospital

Giresun, Center, 28200, Turkey (Türkiye)

Location

Study Officials

  • Ezgi ŞAHİN, ph.D

    Giresun University Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Pregnant women included in the study were randomly divided into two groups using the sealed envelope method.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research is an experimental study with a randomized control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assıstant Professor

Study Record Dates

First Submitted

March 16, 2024

First Posted

March 22, 2024

Study Start

April 1, 2023

Primary Completion

September 10, 2023

Study Completion

September 10, 2023

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations