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Completed

NCT Number: NCT05662176

The Effect of Trauma Informed Care in Childbirth

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.

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Key information

Conditions

Psychological Well-being Behavior Birth Injuries Care Pattern, Maternal Childbirth Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Personal Satisfaction Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gozde Gokce Isbir

Mersin, 33180, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Labor pain

    Time frame: 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.

  2. Fear of Childbirth (DFS)

    Time frame: 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.

  3. Perceived control and support in birth (SCIB)

    Time frame: 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.

  4. Birth Trauma (City BITS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 22, 2022
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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