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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Hatice OKÇU

    Batman, 72100

Other trials in Turkey (Türkiye)

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 groups in NCT05802147
Study groupRoleWhat they receive
Early Skin to Skin Contact GroupExperimentalWomen 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 GroupNo interventionStandard 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.

  1. 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

  2. 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.

  1. First posted6 Apr 2023
  2. Study start16 Dec 2021
  3. Primary completion30 May 2022
  4. Study completion25 Nov 2022

Resources

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)
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

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.

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