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The Effect of Trauma Informed Care in Childbirth

Primary Purpose

Psychological Well-being, Childbirth, Care Pattern, Maternal

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Experimental: Supportive Care based on trauma informed care
Standart care
Sponsored by
Mersin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychological Well-being focused on measuring Intrapartum supportive care, Trauma Informed Care, birth trauma, fear of childbirth, perinatal well-being

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: The ages of 18-40 women, At least primary school graduate, Mother tongue Turkish, Single fetus, Term, Spontaneous birth, Cervical dilatation between 0-5 cm (latent phase) and without a condition that could prevent vaginal delivery. Primiparous women Not have any disease or complication and agreed to participate in the study were included. Exclusion Criteria: Women who developed a complication with the fetus or themselves during delivery, Not be reached during follow-ups by telephone, Wanted to withdraw from the study

Sites / Locations

  • Gozde Gokce Isbir

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental: Supportive Care based on trauma informed care

Control: Standart care

Arm Description

Participants were provided care in different rooms, blinded to the differences in practice used between the two groups. In the same clinic, a room was designed as a positive delivery room by the researchers and a relaxing environment was created. In this room, supportive care based on trauma informed care was provided to the experimental group during birth.

Participants in the control group, on the other hand, received the routine care given in the hospital by other midwives in the clinic, and there was a change of caregiver midwife during shift changes. The care provided in the hospital during delivery is mostly focused on low level of physical comfort and high level of follow-up.

Outcomes

Primary Outcome Measures

Labor pain
Women's labor pain at the time of birth were evaluated with the Visual Analogue Scale (DFS). The individual evaluates pain between "0-10 points. 0- I don't have any pain", "10- I have so much pain that I can't stand it". The higher the pain, the higher the score.
Fear of Childbirth (DFS)
Women's fears at the time of birth were evaluated with the Delivery fear scale (DFS). This scale was developed for fear during delivery. The Turkish validity and reliability of the scale were performed. This scale consisting of 10 items is a 10-point Likert-type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 10 to 100. The scale has no cutoff score, and high scores indicated higher fear.
Perceived control and support in birth (SCIB)
Women's perceptions of support and control at the time of birth were evaluated with the Perceived control and support in birth scale. SCIB was developed to measure perceived support and control in birth. The Turkish validity and reliability of the scale were performed. This scale consisting of 33 items is a 5-pointLikert-type (5 = agree completely to 1 = disagree completely). Ten items are scored in reverse order. The scores ranged from 33 to 165. SCIB subscales include internal control, external control, and support. The scale has no cutoff score, higher scores are associated with a higher degree of perceived support and of control during birth. The Cronbach's alpha for the original scale was measured as .95 and Turkish version was measured as 0.84. In this study, this scale was administered within 24 hours postpartum.
Birth Trauma (City BITS)
Birth trauma of women were evaluated with the City Birth Trauma Scale. City BiTS was developed to measure birth trauma. The Turkish validity and reliability of the scale were performed. The scale is a fourpoint Likert-type instrument composed of 29 items. Higher scores reflect greater risk for Post-traumatic Stress Disorder (PTSD). The Cronbach's alpha for the original scale was measured as .92 and Turkish version was measured as 0.91. In this study, 6-8 days after birth to determine whether they meet the criteria for birth trauma and birth-related PTSD.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2022
Last Updated
March 13, 2023
Sponsor
Mersin University
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1. Study Identification

Unique Protocol Identification Number
NCT05662176
Brief Title
The Effect of Trauma Informed Care in Childbirth
Official Title
The Effect of Supportive Care Based on Trauma Informed Care at Childbirth on Perinatal Mental Health Outcomes: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 31, 2022 (Actual)
Primary Completion Date
December 25, 2022 (Actual)
Study Completion Date
December 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to determine the effect of supportive care based on trauma informed care during childbirth on perinatal mental health outcomes.
Detailed Description
This is a randomized control experimental study. Data were collected from 100 women who attended supportive care based on trauma informed care or standart care from Turkey between July 2022 and September 2022. Participants who met the inclusion criteria were informed about the purpose of the study and the procedures to be performed, informed consent was obtained from those who agreed to participate, and women were assigned to the groups in line with a computer-based randomization program with an allocation ratio of 1:1. Block randomization could not be performed because of the different and long delivery processes. Data were collected in both groups at birth (latent phase, active phase, and transitional phase), within 24 hours of birth, and 6th-8th postpartum days after hospital admission and at least one hour of care. collected by the first author. The CONSORT directive was followed in the planning, implementation and writing of the research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Well-being, Childbirth, Care Pattern, Maternal
Keywords
Intrapartum supportive care, Trauma Informed Care, birth trauma, fear of childbirth, perinatal well-being

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Supportive Care based on trauma informed care
Arm Type
Experimental
Arm Description
Participants were provided care in different rooms, blinded to the differences in practice used between the two groups. In the same clinic, a room was designed as a positive delivery room by the researchers and a relaxing environment was created. In this room, supportive care based on trauma informed care was provided to the experimental group during birth.
Arm Title
Control: Standart care
Arm Type
Other
Arm Description
Participants in the control group, on the other hand, received the routine care given in the hospital by other midwives in the clinic, and there was a change of caregiver midwife during shift changes. The care provided in the hospital during delivery is mostly focused on low level of physical comfort and high level of follow-up.
Intervention Type
Other
Intervention Name(s)
Experimental: Supportive Care based on trauma informed care
Intervention Description
Participants were provided care in different rooms, blinded to the differences in practice used between the two groups. In the same clinic, a room was designed as a positive delivery room by the researchers and a relaxing environment was created. In this room, supportive care based on trauma informed care was provided to the experimental group during birth.
Intervention Type
Other
Intervention Name(s)
Standart care
Intervention Description
Participants in the control group, on the other hand, received the routine care given in the hospital by other midwives in the clinic, and there was a change of caregiver midwife during shift changes. The care provided in the hospital during delivery is mostly focused on low level of physical comfort and high level of follow-up.
Primary Outcome Measure Information:
Title
Labor pain
Description
Women's labor pain at the time of birth were evaluated with the Visual Analogue Scale (DFS). The individual evaluates pain between "0-10 points. 0- I don't have any pain", "10- I have so much pain that I can't stand it". The higher the pain, the higher the score.
Time Frame
through delivery, an average of 24th hours
Title
Fear of Childbirth (DFS)
Description
Women's fears at the time of birth were evaluated with the Delivery fear scale (DFS). This scale was developed for fear during delivery. The Turkish validity and reliability of the scale were performed. This scale consisting of 10 items is a 10-point Likert-type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 10 to 100. The scale has no cutoff score, and high scores indicated higher fear.
Time Frame
through delivery, an average of 24th hours
Title
Perceived control and support in birth (SCIB)
Description
Women's perceptions of support and control at the time of birth were evaluated with the Perceived control and support in birth scale. SCIB was developed to measure perceived support and control in birth. The Turkish validity and reliability of the scale were performed. This scale consisting of 33 items is a 5-pointLikert-type (5 = agree completely to 1 = disagree completely). Ten items are scored in reverse order. The scores ranged from 33 to 165. SCIB subscales include internal control, external control, and support. The scale has no cutoff score, higher scores are associated with a higher degree of perceived support and of control during birth. The Cronbach's alpha for the original scale was measured as .95 and Turkish version was measured as 0.84. In this study, this scale was administered within 24 hours postpartum.
Time Frame
Postpartum 24th hours
Title
Birth Trauma (City BITS)
Description
Birth trauma of women were evaluated with the City Birth Trauma Scale. City BiTS was developed to measure birth trauma. The Turkish validity and reliability of the scale were performed. The scale is a fourpoint Likert-type instrument composed of 29 items. Higher scores reflect greater risk for Post-traumatic Stress Disorder (PTSD). The Cronbach's alpha for the original scale was measured as .92 and Turkish version was measured as 0.91. In this study, 6-8 days after birth to determine whether they meet the criteria for birth trauma and birth-related PTSD.
Time Frame
Postpartum 8 th week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The ages of 18-40 women, At least primary school graduate, Mother tongue Turkish, Single fetus, Term, Spontaneous birth, Cervical dilatation between 0-5 cm (latent phase) and without a condition that could prevent vaginal delivery. Primiparous women Not have any disease or complication and agreed to participate in the study were included. Exclusion Criteria: Women who developed a complication with the fetus or themselves during delivery, Not be reached during follow-ups by telephone, Wanted to withdraw from the study
Facility Information:
Facility Name
Gozde Gokce Isbir
City
Mersin
ZIP/Postal Code
33180
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Trauma Informed Care in Childbirth

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