PostpartumNCT05802147
Analyse Of Early Skın To Skın Contact's Impact Upon Maternal-Infant Bondıng And Perceptıon Of Traumatıc Bırth
A study testing skin-to-skin contact in people with Postpartum, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum
- What is being tested?
- skin-to-skin contact
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2021to 25 Nov 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- Reading and writing Turkish and understanding Turkish
- Single and healthy fetus
- Chief presentation
- Not having a risky pregnancy
- No need for neonatal intensive care
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Postpartum
- Being tested
- skin-to-skin contact
- Keywords
- traumatic birth, maternal attachment, Skin to skin, Midwifery
- Medical subject headings
- Birth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin-to-skin contactBehavioural
skin-to-skin contact
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from birth up to 2 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start16 Dec 2021
- Primary completion30 May 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Okçu, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802147
- Sponsor's protocol ID
- 10436591
- Status last verified
- Mar 2023
- First submitted
- 29 Jan 2023
- Last updated
- 6 Apr 2023
- 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 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyse Of Early Skın To Skın Contact's Impact Upon Maternal-Infant Bondıng And Perceptıon Of Traumatıc Bırth
- ClinicalTrials.gov ID
- NCT05802147
- Acronym / sponsor ID
- 10436591
- Conditions
- Postpartum
- Keywords
- traumatic birth, maternal attachment, Skin to skin, Midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 6 Apr 2023 (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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early Skin to Skin Contact Group | Experimental | Behavioral: skin-to-skin contactWomen 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 | 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| skin-to-skin contactskin-to-skin contact | Behavioural | Early Skin to Skin Contact Group |
Primary outcome
Maternal Attachment Scale Score
Time frame: from birth to 1 month after birth
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
Time frame: from birth up to 2 hours after birth
It was evaluated with the Traumatic birth perception scale developed by Yalnız et al. (2016) to determine the perception of traumatic birth.
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 6 Apr 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin-to-skin contact in people with Postpartum, run by Kahramanmaras Sutcu Imam 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 11 inclusion and 4 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 6 Apr 2023. 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?
Maternal Attachment Scale Score (time frame: from birth to 1 month after birth). The study lists 2 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 6 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.