Supportive Care During Childbirth and Well-being

NCT05333653 | Completed DMC

• 1 other identifier: GIsbir
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Well-being; Childbirth; Care Pattern, Maternal

Keywords

Intrapartum supportive care; birth trauma; fear of childbirth; maternal attachment; perinatal well-being

Outcome Measures

Primary Outcomes (4)

• Fear of Childbirth (DFS)

  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.

  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 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.

  Postpartum 24th hours

• Birth Trauma (City BITS)

  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.

  Postpartum 8 th week

• Maternal Attachment (MAI)

  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.

  Postpartum 8 th week

Study Arms (2)

Continous Supportive 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 parameters recommended by The Royal College of Midwives (2012) were applied to the women in the ICSC group in line with their preferences.

Other: Continouse supportive care

Control

EXPERIMENTAL

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: routine care

Interventions

Continouse supportive 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 parameters recommended by The Royal College of Midwives (2012) were applied to the women in the ICSC group in line with their preferences. Participants in the control group, on the other hand, received routine care given in the hospital by other midwives in the clinic.

Continous Supportive Care

routine 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

Eligibility Criteria

• Age: 18 Years - 50 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 0-6 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.

You may not qualify if:

• 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

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 Officials

• Gozde Gokce Isbir

  Mersin University

  PRINCIPAL INVESTIGATOR

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: February 2, 2022
• First Posted: April 19, 2022
• Study Start: December 15, 2020
• Primary Completion: March 15, 2021
• Study Completion: June 27, 2021
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)