NCT05802147

Brief Summary

This study will carry out as a randomized controlled experimental study in order to examine the effect of early skin-to-skin contact on mother-infant attachment and traumatic birth perception and to provide new information to the literature. The sample of the study consist of 350 women who apply to the Training and Research Hospital in the city center of Batman between December 2021 and May 2022, and who agreed to participate as the study group (n:175) and the control group (n: 175), who had a normal delivery in the delivery room. hascreated. "Personal Questionnaire Form", "Traumatic Birth Perception Scale" and "MaternalAttachment Scale" forms were used in the analysis of the data. Data analysis was done with SPSS 24 program

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

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

December 16, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
Last Updated

April 6, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

January 29, 2023

Last Update Submit

March 26, 2023

Conditions

Keywords

traumatic birthmaternal attachmentSkin to skinMidwifery

Outcome Measures

Primary Outcomes (2)

  • Maternal Attachment Scale Score

    Maternal attachment scale, developed by Mary E. Muller in 1994 and adapted to Turkish by Kavlak and Şirin in 2009, was used to evaluate the bond between mother and baby.

    from birth to 1 month after birth

  • Traumatic Birth Perception Scale Score

    It was evaluated with the Traumatic birth perception scale developed by Yalnız et al. (2016) to determine the perception of traumatic birth.

    from birth up to 2 hours after birth

Study Arms (2)

Early Skin to Skin Contact Group

EXPERIMENTAL

Women who met the criteria for inclusion in the study and accepted the study (n:180) were told how to apply skin-to-skin contact. Skin-to-skin contact was initiated within the first minutes of normal delivery and skin-to-skin contact was applied to the mothers for a minimum of 15 minutes (due to the high number and frequency of births in the TDL service and hospital conditions). Routine newborn care procedures (eye drops, vaccination, footprints, etc.) performed in the delivery room were performed during skin-to-skin contact. After the skin-to-skin contact between the mother and the newborn was terminated at the end of delivery, 2 hours later, mothers were asked to fill in a personal questionnaire and a traumatic birth scale. The maternal attachment scale was completed 1 month after birth by telephone interview.

Behavioral: skin-to-skin contact

Control Group

NO INTERVENTION

Standard midwifery practices and labor follow-up were applied to women who met the inclusion criteria in the hospital (during the delivery room) (n: 187), agreed to participate in the study, and were in the control group. Neonatal routine care procedures (vaccine, footprint, eye drop application, etc.) of the postpartum hospital were performed. Then, after 2 hours postpartum, mothers were asked to fill in a personal questionnaire and a traumatic birth scale. The maternal attachment scale was completed 1 month after birth by telephone interview.

Interventions

skin-to-skin contact

Early Skin to Skin Contact Group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Agreeing to participate in the study
  • Do not give vaginal birth
  • Being between 37-42 weeks of gestation
  • Not having a hearing or visual impairment
  • Being between the ages of 18-49
  • Not having a psychiatric diagnosis
  • Reading and writing Turkish and understanding Turkish
  • Single and healthy fetus
  • Chief presentation
  • Not having a risky pregnancy
  • No need for neonatal intensive care

You may not qualify if:

  • Not completing the forms,
  • Having multiple pregnancy,
  • Women who refused to participate in the study were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatice OKÇU

Batman, 72100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Birth Injuries

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was carried out as a randomized controlled experimental study in order to examine the effect of early skin-to-skin contact on mother-infant attachment and traumatic birth perception and to provide new information to the literature. The sample of the study consisted of 350 women who applied to the Training and Research Hospital in the city center of Batman between December 2021 and May 2022, and who agreed to participate as the study group (n: 175) and the control group (n: 175), who had a normal delivery in the delivery room has created.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2023

First Posted

April 6, 2023

Study Start

December 16, 2021

Primary Completion

May 30, 2022

Study Completion

November 25, 2022

Last Updated

April 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations