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Analyse Of Early Skın To Skın Contact's Impact Upon Maternal-Infant Bondıng And Perceptıon Of Traumatıc Bırth

Primary Purpose

Postpartum

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
skin-to-skin contact
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postpartum focused on measuring traumatic birth, maternal attachment, Skin to skin, Midwifery

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: Not meeting the inclusion criteria, Not completing the forms, Having multiple pregnancy, Women who refused to participate in the study were excluded from the study.

Sites / Locations

  • Hatice OKÇU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early Skin to Skin Contact Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 29, 2023
Last Updated
March 26, 2023
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT05802147
Brief Title
Analyse Of Early Skın To Skın Contact's Impact Upon Maternal-Infant Bondıng And Perceptıon Of Traumatıc Bırth
Official Title
Analyse Of Early Skın To Skın Contact's Impact Upon Maternal-Infant Bondıng And Perceptıon Of Traumatıc Bırth
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
November 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
The population of the study consisted of puerperant women who gave normal birth in Batman Training and Research Hospital TDL (Travay-Birth-Postpartum) service between December 2021 and May 2022. The population of the research was determined as N:2760 for the 6-month data collection period in the center with a monthly average of 460 normal births.The sample of the study consisted of women who met the research conditions and accepted the study. In our study, the sample population was calculated as n:338 people with a 95% confidence interval using the known sample calculation method. The sample number was determined as n:367 puerperant women, since there may be a loss of cases in the research (desire to leave the research, interruption of attachment, not filling out the entire questionnaire…). Inclusion Criteria: Agreeing to participate in the study, Vaginal delivery, Being between 37-42 weeks of gestation, Hearing and visual impairment, Be between 18-49 years old, No psychiatric diagnosis, Reading and writing Turkish and understanding Turkish, Single and healthy fetus, Head presentation, Not having a high-risk pregnancy, No need for neonatal intensive care Exclusion Criteria in Research: Not meeting the inclusion criteria,Not completing the forms, Multiple pregnancy, Women who refused to participate in the study were excluded from the study. Randomization: In order to keep the number of people in balance between the groups, the "block randomization" method, one of the fixed-probability randomization methods, was used. By using a computer program module (http://www.randomr.org/form.htm) used in randomization-controlled studies using the block randomization method, the data were collected at one-week intervals considering the inclusion criteria in order not to affect the groups compared to each other. group (A), 2nd week control group (B), 3rd week study group (A), 4th week control group (B), …)." Which group to start with first was determined by a person independent of the research using the coin-print method. Working Group: 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. Control Group: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum
Keywords
traumatic birth, maternal attachment, Skin to skin, Midwifery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Skin to Skin Contact Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
skin-to-skin contact
Intervention Description
skin-to-skin contact
Primary Outcome Measure Information:
Title
Maternal Attachment Scale Score
Description
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.
Time Frame
from birth to 1 month after birth
Title
Traumatic Birth Perception Scale Score
Description
It was evaluated with the Traumatic birth perception scale developed by Yalnız et al. (2016) to determine the perception of traumatic birth.
Time Frame
from birth up to 2 hours after birth

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Not meeting the inclusion criteria, Not completing the forms, Having multiple pregnancy, Women who refused to participate in the study were excluded from the study.
Facility Information:
Facility Name
Hatice OKÇU
City
Batman
ZIP/Postal Code
72100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Analyse Of Early Skın To Skın Contact's Impact Upon Maternal-Infant Bondıng And Perceptıon Of Traumatıc Bırth

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