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
1 other identifier
interventional
110
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2022
CompletedFirst Submitted
Initial submission to the registry
July 15, 2022
CompletedFirst Posted
Study publicly available on registry
July 29, 2022
CompletedJuly 29, 2022
July 1, 2022
Same day
July 15, 2022
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
EXPERIMENTALParticipants 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.
60 minutes skin to skin contact
EXPERIMENTALParticipants 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.
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.
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.
Eligibility Criteria
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)
Study Officials
- PRINCIPAL INVESTIGATOR
Gozde Gokce Isbir
Mersin University
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