NCT06754111

Brief Summary

The aim of this study was to investigate whether the ideal birth environment is related to fear of childbirth, labor pain, duration of labor, and mode of delivery. on the impact of the study. The main questions it aims to answer are Does the ideal birth environment reduce fear of childbirth? Does the ideal birth environment reduce labor pain? does the ideal birth environment affect the duration of labor? In order to evaluate the effect of the ideal birth environment on fear, pain and duration of labor, the researchers will compare the standard delivery room and women who will give birth in a room customized for women, where they have their own sheets, pillows, items that make them feel special, where medical devices are reduced, in a room where they have photos with their partner, in a room where they listen to the music they want, where they have freedom of movement. both in the experimental and control groups: In the last trimester, the Wijma birth experience A version will be applied and in the postpartum period, the Wijma B Birth experience scale will be applied again and the fear of childbirth will be evaluated. Pain in labor will also be assessed using VAS (Visceral Visual Analgesic Scale) during the latent and active phase of labor.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

October 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 10, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

labor painideal birth environmentfear of childbirth

Outcome Measures

Primary Outcomes (3)

  • Wijma Birth Expectancy/Expectation Questionnaire (W-DEQ) A Version

    Wijma Birth Expectancy/Expectation Scale A Version (W-DEQ A), W-DEQ consists of 33 items and is a six-point Likert-type scale. Item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all". is expressed. The minimum score is 0 and the maximum score is 165. The cut-off value is 85 points and a score of 85 and above is expressed as clinical fear. is also analyzed. The higher the total score of the scale, the higher the degree of fear experienced. is high. * W-DEQ score? 37 mild, * W-DEQ score = 38-65 moderate, * W-DEQ score = 66-84 in severe degree, * A W-DEQ score of ? 85 indicates a clinical degree of fear. Scale 2, Questions 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 are negatively loaded and there is no agreement in the measurement. The alpha value of the scale is calculated by inverting the scale in the opposite direction. Cronbach's alpha value of the scale 0.89 (Korukcu et al., 2012) Wijma Birth Anticipation/Experience Sc

    28-36 weeks of gestation

  • VASA Pain Assessment Scale

    Quantitative pain rating scale (QPRS) is used to assess the severity of pain. is used. On a numerical rating scale, pain ranges from 0 (no pain) to 10 (unbearable pain) score (Price et al., 1983).

    during the latent phase of labor when the cervical opening is 1-3 cm and during the active phase of labor when the cervical opening is 5-7 cm

  • WIJMA BIRTH EXPECTANCY/EXPERIENCE SCALE B VERSION

    he W-DEQ consists of 33 items and is a six-point Likert-type questionnaire. Item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all". is expressed. The minimum score is 0 and the maximum score is 165. The cut-off value is 85 points and a score of 85 and above is expressed as clinical fear. is also analyzed. The higher the total score of the scale, the higher the degree of fear experienced. is high. * W-DEQ score? 37 mild, * W-DEQ score = 38-65 moderate, * W-DEQ score = 66-84 in severe degree, * A W-DEQ score of ? 85 indicates a clinical degree of fear. Scale 2, Questions 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 are negatively loaded and there is no agreement in the measurement. is calculated by inverting it in the opposite direction in order to provide Translated with www.DeepL.com/Translator (free version)

    up to the first 12 hours after birth

Study Arms (2)

control group

NO INTERVENTION

will receive standard care, no intervention will be performed

ideal birth environment

ACTIVE COMPARATOR

ideal birth room While designing a single room without unnecessary medical equipment, your own bed linen, bed linen, It will be a pillow case, a photo frame, he will be able to listen to the music he wants, he will be able to make a photo of his own choice. There will be a companion, a birthing ball and chair, and the room will allow freedom of movement. It will be designed to allow

Behavioral: ideal birth environment

Interventions

ideal birth room While designing a single room without unnecessary medical equipment, your own bed linen, bed linen, It will be a pillow case, a photo frame, he will be able to listen to the music he wants, he will be able to make a photo of his own choice. There will be a companion, a birthing ball and chair, and the room will allow freedom of movement. It will be designed to allow

ideal birth environment

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old pregnant primiparous literate

You may not qualify if:

  • Medium and high-risk pregnant women (oligohydramnios, pre-eclampsia, heart disease, diabetes, placenta previa)
  • Psychiatric illness such as anxiety and depression
  • Communication barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmet Akif Ersoy Üniversitesi

Burdur, Bucak, 15300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 31, 2024

Study Start

October 1, 2024

Primary Completion

April 1, 2025

Study Completion

July 1, 2025

Last Updated

December 31, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations