Skin-to-skin Contact Time and Maternal Psychology

Skin to Skin Contact Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05479955
• Other study ID #: GGI
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: February 17, 2022

Study information

• Verified date: July 2022
• Source: Mersin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 17, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria

• Must be able to a normal term vaginal delivery,

• Native language is Turkish,

• Have single fetus

• Must be able to skin to skin contact wit her baby

Exclusion Criteria

• Cesarean section,

• Complications,

• Psychological or psychiatric disorder,

Related Conditions & MeSH terms

• Skin to Skin Contact

Intervention

Other:
• 5 minutes skin to skin contact
Skin-to-skin contact is defined as placing a naked baby on the mother's bare stomach or breast for at least one hour immediately after birth. The women in this group received 5 minutes of skin-to-skin contact as a clinic routine.
• 60 minutes skin to skin contact
Skin-to-skin contact is defined as placing a naked baby on the mother's bare stomach or breast for at least one hour immediately after birth. In line with the recommendation of the World Health Organization, 60 minutes of skin-to-skin contact was applied to the women in this group.

Locations

Country	Name	City	State
Turkey	Gozde Gokce Isbir	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Fear of Childbirth	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.	Postpartum with in 4th- 24th hours
Primary	Level of Birth Trauma	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 Bayri 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 (Bayri 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 4th weeks
Primary	Level of Maternal Attachment	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 4th weeks
Primary	Level of Birth Trauma	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 Bayri 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 (Bayri 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 4th month
Primary	Level of Maternal Attachment	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 4th month