Supportive Care During Childbirth and Well-being

Not Applicable

Completed

• Conditions: Care Pattern, Maternal; Childbirth; Psychological Well-being

• Registration Number: NCT05333653
• Lead Sponsor: Mersin University

Brief Summary

The aim of this study is to evaluate the effects of continuous supportive care (ICSC) at birth on some parameters of maternal psychological well-being.

Detailed Description

This is a single-blind randomized controlled trial. Data were collected from 80 women who gave birth in the obstetrics clinic of a state hospital in the south of Turkey between December 2020 and June 2021. 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: 2020-12-15
• Primary Completion: 2021-03-15
• Study Completion: 2021-06-27
• Study First Submitted: 2022-02-02
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-18
• Last Update Submitted: 2022-04-18
• Study First Posted: 2022-04-19
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

Inclusion Criteria

• The ages of 18-40 women,
• At least primary school graduate,
• Mother tongue Turkish,
• Single fetus,
• Term,
• Spontaneous birth,
• Cervical dilatation between 0-6 cm (latent phase) and without a condition that could prevent vaginal delivery.
• Primiparous and multiparous 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,
• Underwent emergency cesarean section,
• Not be reached during follow-ups by telephone,
• Wanted to withdraw from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 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.
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.
Maternal Attachment (MAI)	Postpartum 8 th week	Maternal attachment of women was evaluated with the Maternal Attachment Inventory.; MAI, was developed by Muller (1994) to measure maternal attachment. The Turkish validity and reliability of the scale were performed by Kavlak et al. (2009). This scale consisting of 26 items is a 4-point Likert-type (4 = every time to 1 = any time). The scores ranged from 26 to 104 and high scores indicated higher maternal attachment. The Cronbach's alpha for the original scale was measured as .76 - .85 at different time (Muller, 1994) and Turkish version was measured as 0.77 (Kavlak et al., 2009). In this study, 6th to 8th postnatal days were used to measure maternal attachment.

Trial Locations

Locations (1)

Gozde Gokce Isbir; 🇹🇷 Mersin, Turkey