Supportive Care During Childbirth and Well-being

NCT ID: NCT05333653

Last Updated: 2022-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2021-06-27

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.

Conditions

Psychological Well-being; Childbirth; Care Pattern, Maternal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Continouse supportive care

Intervention Type: 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.

Control

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.

Group Type: EXPERIMENTAL

routine care

Intervention Type: 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.

Interventions

Continouse supportive 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 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.

Intervention Type: OTHER

routine 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Gozde Gokce Isbir

Associate Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gozde Gokce Isbir

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Locations

Gozde Gokce Isbir

Mersin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GIsbir

Identifier Type: -

Identifier Source: org_study_id