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Clinical Trials/NCT05479955
NCT05479955
Completed
Not Applicable

The Effect of Skin to Skin Contact Time After Childbirth on Fear of Child Birth, Birth Trauma and Maternal Attachment: A Single-blind Randomized Controlled Trial

Mersin University1 site in 1 country110 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Skin to Skin Contact
Sponsor
Mersin University
Enrollment
110
Locations
1
Primary Endpoint
Level of Fear of Childbirth
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The aim of this study was to determine the effect of postpartum skin-to-skin contact time on fear of childbirth, birth trauma and maternal attachment.

Detailed Description

This is a single-blind, randomized controlled trial. Data were collected from 110 women who gave birth in the gynecology clinic of a public hospital in southern Turkey between September 2021 and February 2022. Participants who met the inclusion criteria were informed about the purpose of the study and skin-to-skin contact, informed consent was obtained from those who agreed to participate, and the women were divided into groups according to a 1:1 computer-based randomization program. Data were collected at the time of consent to the study, within the first hour after birth, 24 hours after birth, 4 weeks postpartum, and 4 months postpartum. Collected by the first author. The CONSORT directive was followed in the planning, implementation and writing of the research.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
February 17, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gozde Gokce Isbir

Associate Prof

Mersin University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Level of Fear of Childbirth

Time Frame: Postpartum with in 4th- 24th hours

Women's fears after childbirth were evaluated with the Wijma Delivery Expectancy/Experience Questionnaire Version B version (W-DEQ-B). This scale was developed by Wijma et al (1998) for fear after childbirth. The Turkish validity and reliability of the scale were performed by Korukcu et al. (2016). This scale consisting of 33 items is a 5-point Likert-type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 0 to 165. The scale has no cutoff score, and high scores indicated higher fear.

Level of Birth Trauma

Time Frame: Postpartum 4th month

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.

Level of Maternal Attachment

Time Frame: Postpartum 4th month

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.

Study Sites (1)

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