The Effect of Trauma Informed Care in Childbirth

Sponsor

Mersin University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05662176

Collaborator

(none)

Enrollment

Location

Arms

4.8

Anticipated Duration (Months)

18.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psychological Well-being Childbirth Care Pattern, Maternal	Other: Experimental: Supportive Care based on trauma informed care Other: Standart care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Supportive Care Based on Trauma Informed Care at Childbirth on Perinatal Mental Health Outcomes: a Randomized Controlled Study

Actual Study Start Date :

Jul 31, 2022

Actual Primary Completion Date :

Sep 15, 2022

Anticipated Study Completion Date :

Dec 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Supportive Care based on trauma informed care 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 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: Control: 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.	Other: 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.

Arm

Intervention/Treatment

Experimental: Experimental: Supportive Care based on trauma informed care

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

Other: Control: 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.

Other: Standart care

Outcome Measures

Primary Outcome Measures

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).
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 by Wijma et al (2002) for fear during delivery. The Turkish validity and reliability of the scale were performed by Sercekus et al. (2017). 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) [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 by Ford et al., (2009) to measure perceived support and control in birth. The Turkish validity and reliability of the scale were performed by Inci et al. (2015). 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 (Ford et al., 2009) and Turkish version was measured as 0.84 (Inci et al.,2015). 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 by Ayers et al., (2018) to measure birth trauma. The Turkish validity and reliability of the scale were performed by Bayrı Bingöl et al. (2021). 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 (Ayers et al.,2018) and Turkish version was measured as 0.91 (Bayrı Bingöl et al., 2021). In this study, 6-8 days after birth to determine whether they meet the criteria for birth trauma and birth-related PTSD.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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