Maternal-Fetal RelationsNCT03357965
Familiy Medicine Perspective to Maternal-infant Bonding
An observational study of Maternal-Fetal Relations and Depression, run by Yildiz Atadag at 1 site in Turkey (Türkiye).
Trial summary
Maternal bonding was described as a qualitative change in the relationship of a mother with her infant. By this study, the investigators aimed to investigate the mother-infant bonding and the factors affecting it, from the point of the family practice, which is responsible for the healthcare of all family members from… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Maternal-Fetal Relations, Depression, Anxiety
- What is being tested?
- Questionnaire
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2016to 1 Feb 2017
- Phase
- Observational
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: The universe of the study consists of the mothers in the first 6 weeks of the postpartum period presenting to the Obstetrics and Gynecology Clinic and the mothers of the pediatric patients presenting to the Pediatric Clinic of the Health Sciences University Umraniye Training and Research Hospital.
Who may be able to join
- Women who gave birth in 6 weeks
- Women who had no mental illness history
- Women who had no health issue
- Women who accepted to join the study
- Women who can communicate
Who cannot join
- The women who did not have the features below the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep Sahinbey Baglarbasi Family Health Center
Gaziantep
About this study
Official title: Evaulation of Maternal-infant Bonding in Postpartum Period of Healthy Women With Family Medicine Perspective
Maternal bonding was described as a qualitative change in the relationship of a mother with her infant. By this study, the investigators aimed to investigate the mother-infant bonding and the factors affecting it, from the point of the family practice, which is responsible for the healthcare of all family members from the fetus to the eldest individual in a family.
Read the detailed description
The study was carried out as a single-centered descriptive research among 73 women at the postpartum period. The sociodemographic status and the histories of pregnancies of the study participants were recorded. The Maternal Attachment Inventory (MAI), which questions the biological, psychological and social factors, and the Hospital Anxiety and Depression Scale (HADS) were used to collect data to determine the factors affecting the mother-infant bonding in the postpartum period.
The study is a descriptive survey study, which was conducted to determine the mother-infant attachment and its affecting factors in mothers in the first 6-week of the postpartum period. In order to conduct the study, the local Ethics Committee approval was obtained. (Approval date: 24.11.2016, number 18517).
The mean score of the Turkish version of the Maternal Attachment Inventory (MAI) is approximately 95+6 according to the validation study. In our study, considering that the average MAI score of the participants would be approximately 97, investigators determined to include 73 patients in the study with a type I error set at a=0.05 and with the power of (1-b) 80%.
The universe of the study consists of the mothers in the first 6 weeks of the postpartum period presenting to the Obstetrics and Gynecology Clinic and the mothers of the pediatric patients presenting to the Pediatric Clinic of the Health Sciences University Umraniye Education and Research Hospital.
- Conditions
- Maternal-Fetal Relations, Depression, Anxiety
- Being tested
- Questionnaire
- Keywords
- maternal infant bonding, depression, anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Women who had gave birth in 6 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Attachment Inventory
The items of the MAI are designed in the 4-point Likert scale, which can be scored between 1 and 4 (1: never, 2: sometimes, 3: often, 4: always). The increasing scores indicate increasing levels of attachment of the mother.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Dec 2016
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Maternal-Fetal RelationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yildiz Atadag
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yildiz Atadag, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357965
- Sponsor's protocol ID
- 18517
- Status last verified
- Nov 2017
- First submitted
- 20 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bowlby J. Attachment and Loss Volume I: Attachment. 2nd ed. New York: Basic Books Inc; 1982
Cranley MS. Development of a tool for the measurement of maternal attachment during pregnancy. Nurs Res. 1981 Sep-Oct;30(5):281-4.
PubMed 6912989BOWLBY J. The nature of the child's tie to his mother. Int J Psychoanal. 1958 Sep-Oct;39(5):350-73. No abstract available.
PubMed 13610508Bowlby J. Attachment and Loss Volume II: Separation. Anxiety and Anger. New York: Basics Books, Inc; 1973.
Rodriguez CM, Tucker MC. Behind the cycle of violence, beyond abuse history: a brief report on the association of parental attachment to physical child abuse potential. Violence Vict. 2011;26(2):246-56. doi: 10.1891/0886-6708.26.2.246.
PubMed 21780538Kapci EG, Kucuker S. [The parental bonding instrument: evaluation of psychometric properties with Turkish university students]. Turk Psikiyatri Derg. 2006 Winter;17(4):286-95. Turkish.
PubMed 17183445Noriuchi M, Kikuchi Y, Senoo A. The functional neuroanatomy of maternal love: mother's response to infant's attachment behaviors. Biol Psychiatry. 2008 Feb 15;63(4):415-23. doi: 10.1016/j.biopsych.2007.05.018. Epub 2007 Aug 7.
PubMed 17686467Pirdal H, Yalçın BM, Ünal M. Knowledge levels of pregnants on their pregnancy and the related factors. Turkish Journal of Family Practice. 2016;20(1):7-15.
Atadağ Y, Aydın A, Kaya D, Köşker HD, Başak, F, Uçak S. Changes in causes of admission to tertiary health care center with family medicine implementation. Turkish Journal of Family Practice. 2016;20(4):141-151
Aydemir Ö, Güvenir T, Küey L ve ark (1997) Validity and Reliability of Turkish Version of Hospital Anxiety and Depression Scale. Turkish Journal of Pscyhiatry. 8(4): 280-287.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaulation of Maternal-infant Bonding in Postpartum Period of Healthy Women With Family Medicine Perspective
- ClinicalTrials.gov ID
- NCT03357965
- Acronym / sponsor ID
- 18517
- Conditions
- Maternal-Fetal Relations, Depression, Anxiety
- Keywords
- maternal infant bonding, depression, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Yildiz AtadagOther government
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 30 Nov 2017 (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.
Maternal bonding was described as a qualitative change in the relationship of a mother with her infant. By this study, the investigators aimed to investigate the mother-infant bonding and the factors affecting it, from the point of the family practice, which is responsible for the healthcare of all family members from the fetus to the eldest individual in a family.
Detailed description
The study was carried out as a single-centered descriptive research among 73 women at the postpartum period. The sociodemographic status and the histories of pregnancies of the study participants were recorded. The Maternal Attachment Inventory (MAI), which questions the biological, psychological and social factors, and the Hospital Anxiety and Depression Scale (HADS) were used to collect data to determine the factors affecting the mother-infant bonding in the postpartum period.
The study is a descriptive survey study, which was conducted to determine the mother-infant attachment and its affecting factors in mothers in the first 6-week of the postpartum period. In order to conduct the study, the local Ethics Committee approval was obtained. (Approval date: 24.11.2016, number 18517).
The mean score of the Turkish version of the Maternal Attachment Inventory (MAI) is approximately 95+6 according to the validation study. In our study, considering that the average MAI score of the participants would be approximately 97, investigators determined to include 73 patients in the study with a type I error set at a=0.05 and with the power of (1-b) 80%.
The universe of the study consists of the mothers in the first 6 weeks of the postpartum period presenting to the Obstetrics and Gynecology Clinic and the mothers of the pediatric patients presenting to the Pediatric Clinic of the Health Sciences University Umraniye Education and Research Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- The universe of the study consists of the mothers in the first 6 weeks of the postpartum period presenting to the Obstetrics and Gynecology Clinic and the mothers of the pediatric patients presenting to the Pediatric Clinic of the Health Sciences University Umraniye Training and Research Hospital.
Key inclusion criteria (5 listed)
- Women who gave birth in 6 weeks
- Women who had no mental illness history
- Women who had no health issue
- Women who accepted to join the study
- Women who can communicate
Key exclusion criteria (1 listed)
- The women who did not have the features below the inclusion criteria
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 |
|---|---|---|
| QuestionnaireWomen who had gave birth in 6 weeks | Other | – |
Primary outcome
Maternal Attachment Inventory
Time frame: 20 minutes
The items of the MAI are designed in the 4-point Likert scale, which can be scored between 1 and 4 (1: never, 2: sometimes, 3: often, 4: always). The increasing scores indicate increasing levels of attachment of the mother.
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 30 Nov 2017.
- BackgroundBowlby J. Attachment and Loss Volume I: Attachment. 2nd ed. New York: Basic Books Inc; 1982
- Background: PubMed 6912989Cranley MS. Development of a tool for the measurement of maternal attachment during pregnancy. Nurs Res. 1981 Sep-Oct;30(5):281-4.
- Background: PubMed 13610508BOWLBY J. The nature of the child's tie to his mother. Int J Psychoanal. 1958 Sep-Oct;39(5):350-73. No abstract available.
- BackgroundBowlby J. Attachment and Loss Volume II: Separation. Anxiety and Anger. New York: Basics Books, Inc; 1973.
- Background: PubMed 21780538Rodriguez CM, Tucker MC. Behind the cycle of violence, beyond abuse history: a brief report on the association of parental attachment to physical child abuse potential. Violence Vict. 2011;26(2):246-56. doi: 10.1891/0886-6708.26.2.246.
- Background: PubMed 17183445Kapci EG, Kucuker S. [The parental bonding instrument: evaluation of psychometric properties with Turkish university students]. Turk Psikiyatri Derg. 2006 Winter;17(4):286-95. Turkish.
- Background: PubMed 17686467Noriuchi M, Kikuchi Y, Senoo A. The functional neuroanatomy of maternal love: mother's response to infant's attachment behaviors. Biol Psychiatry. 2008 Feb 15;63(4):415-23. doi: 10.1016/j.biopsych.2007.05.018. Epub 2007 Aug 7.
- BackgroundPirdal H, Yalçın BM, Ünal M. Knowledge levels of pregnants on their pregnancy and the related factors. Turkish Journal of Family Practice. 2016;20(1):7-15.
- BackgroundAtadağ Y, Aydın A, Kaya D, Köşker HD, Başak, F, Uçak S. Changes in causes of admission to tertiary health care center with family medicine implementation. Turkish Journal of Family Practice. 2016;20(4):141-151
- BackgroundAydemir Ö, Güvenir T, Küey L ve ark (1997) Validity and Reliability of Turkish Version of Hospital Anxiety and Depression Scale. Turkish Journal of Pscyhiatry. 8(4): 280-287.
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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?
An observational study of Maternal-Fetal Relations and Depression, run by Yildiz Atadag 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 5 inclusion and 1 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 30 Nov 2017. 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 Inventory (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03357965, which also lists 10 linked publications.
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 30 Nov 2017.