Skin to Skin ContactNCT05479955
Skin-to-skin Contact Time and Maternal Psychology
A study testing 5 minutes skin to skin contact and 60 minutes skin to skin contact in people with Skin to Skin Contact, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin to Skin Contact
- What is being tested?
- 5 minutes skin to skin contact and 60 minutes skin to skin contact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Cesarean section,
- Complications,
- Psychological or psychiatric disorder,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
This is a single-blind, randomized controlled trial. Data were collected from 110 women who gave birth in the gynecology clinic of a public hospital in southern Turkey between September 2021 and February 2022. Participants who met the inclusion criteria were informed about the purpose of the study and skin-to-skin contact, informed consent was obtained from those who agreed to participate, and the women were divided into groups according to a 1:1 computer-based randomization program. Data were collected at the time of consent to the study, within the first hour after birth, 24 hours after birth, 4 weeks postpartum, and 4 months postpartum. Collected by the first author. The CONSORT directive was followed in the planning, implementation and writing of the research.
- Conditions
- Skin to Skin Contact
- Being tested
- 5 minutes skin to skin contact, 60 minutes skin to skin contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 minutes skin to skin contactOther
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.
60 minutes skin to skin contactOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: 60 minutes skin to skin contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postpartum 4th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Sep 2021
- Primary completion1 Sep 2021
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin to Skin ContactStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gozde Gokce Isbir, Mersin University
- Investigators
- Gozde Gokce Isbir, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479955
- Sponsor's protocol ID
- GGI
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05479955
- Acronym / sponsor ID
- GGI
- Conditions
- Skin to Skin Contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-blind, randomized controlled trial. Data were collected from 110 women who gave birth in the gynecology clinic of a public hospital in southern Turkey between September 2021 and February 2022. Participants who met the inclusion criteria were informed about the purpose of the study and skin-to-skin contact, informed consent was obtained from those who agreed to participate, and the women were divided into groups according to a 1:1 computer-based randomization program. Data were collected at the time of consent to the study, within the first hour after birth, 24 hours after birth, 4 weeks postpartum, and 4 months postpartum. Collected by the first author. The CONSORT directive was followed in the planning, implementation and writing of the research.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 minutes skin to skin contact | Experimental | Other: 5 minutes skin to skin contactParticipants 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 | Experimental | Other: 60 minutes skin to skin contactParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Cesarean section,
- Complications,
- Psychological or psychiatric disorder,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 minutes skin to skin contactSkin-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. | Other | 5 minutes skin to skin contact |
| 60 minutes skin to skin contactSkin-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. | Other | 60 minutes skin to skin contact |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gozde Gokce Isbir principal investigator
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 minutes skin to skin contact and 60 minutes skin to skin contact in people with Skin to Skin Contact, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Fear of Childbirth (time frame: Postpartum with in 4th- 24th hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.