The Effect of Trauma Informed Care in Childbirth

NCT05662176 | Completed

• 1 other identifier: DND
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Well-being; Childbirth; Care Pattern, Maternal

Keywords

Intrapartum supportive care; Trauma Informed Care; birth trauma; fear of childbirth; perinatal well-being

Outcome Measures

Primary Outcomes (4)

• 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.

  through delivery, an average of 24th hours

• 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.

  through delivery, an average of 24th hours

• 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.

  Postpartum 24th hours

• 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.

  Postpartum 8 th week

Study Arms (2)

Experimental: Supportive Care based on trauma informed care

EXPERIMENTAL

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.

Other: Experimental: Supportive Care based on trauma informed care

Control: Standart care

OTHER

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.

Other: Standart care

Interventions

Experimental: Supportive Care based on trauma informed care OTHER

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.

Experimental: Supportive Care based on trauma informed care

Standart care OTHER

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.

Control: Standart care

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Gozde Gokce Isbir

Mersin, 33180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychological Well-Being; Birth Injuries

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 22, 2022
• Study Start: July 31, 2022
• Primary Completion: December 25, 2022
• Study Completion: December 25, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)