NCT05479955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

Same day

First QC Date

July 15, 2022

Last Update Submit

July 26, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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 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 4th weeks

  • 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

  • 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 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 4th month

  • 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

Study Arms (2)

5 minutes skin to skin contact

EXPERIMENTAL

Participants were provided care in different rooms, blinded to the differences in practice used between the two groups. Skin-to-skin contact was applied to the babies of the women in this group for 5 minutes immediately after birth. After the application, routine follow-up and care of the newborn was performed and kept under a radiant heater. When the woman became stable, her baby was given and breastfeeding was supported.

Other: 5 minutes skin to skin contact

60 minutes skin to skin contact

EXPERIMENTAL

Participants were provided care in different rooms, blinded to the differences in practice used between the two groups. Skin-to-skin contact application was initiated to the babies of the women in this group immediately after birth and was applied continuously for 60 minutes as recommended by WHO. Follow-up and care of the newborn were done during the application. At the end of 60 minutes, the baby was dressed and given to its mother.

Other: 60 minutes skin to skin contact

Interventions

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.

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. 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.

60 minutes skin to skin contact

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Cesarean section,
  • Complications,
  • Psychological or psychiatric disorder,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gozde Gokce Isbir

Mersin, 33180, Turkey (Türkiye)

Location

Study Officials

  • Gozde Gokce Isbir

    Mersin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof

Study Record Dates

First Submitted

July 15, 2022

First Posted

July 29, 2022

Study Start

September 1, 2021

Primary Completion

September 1, 2021

Study Completion

February 17, 2022

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations