- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05479955
Skin-to-skin Contact Time and Maternal Psychology
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mersin, Turkey, 33180
- Gozde Gokce Isbir
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 5 minutes skin to skin contact
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.
|
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.
|
|
Experimental: 60 minutes skin to skin contact
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Postpartum with in 4th- 24th hours
|
|
Level of Birth Trauma
Time Frame: Postpartum 4th weeks
|
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
Time Frame: Postpartum 4th weeks
|
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
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.
|
Postpartum 4th month
|
|
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. |
Postpartum 4th month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GGI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.