The Effect of Trauma Informed Care in Childbirth

Not Applicable

Completed

• Conditions: Psychological Well-being; Childbirth; Care Pattern, Maternal
• Interventions: Other: Standart care

• Registration Number: NCT05662176
• Lead Sponsor: Mersin University

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.

Study Timeline

• Study Start: 2022-07-31
• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-22
• Primary Completion: 2022-12-25
• Study Completion: 2022-12-25
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control: Standart care	Standart care	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 Measures

Name	Time	Method
Perceived control and support in birth (SCIB)	Postpartum 24th hours	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)	Postpartum 8 th week	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.
Labor pain	through delivery, an average of 24th hours	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)	through delivery, an average of 24th hours	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.

Trial Locations

Locations (1)

Gozde Gokce Isbir; 🇹🇷 Mersin, Turkey