- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05443152
The Effect of Self-made Fetal Movement and Position Tracking During Pregnancy on Maternal Attachment
July 1, 2022 updated by: AYSUN BADEM
The Effect of Self-made Fetal Movement and Position Tracking During Pregnancy on Maternal Attachment in the Postpartum Period
This study was conducted to determine the effect of self-made fetal movement counting and fetal position tracking on maternal attachment in prenatal period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The first attachment between mother and baby begins in the prenatal period.
It is expected to increase as pregnancy progresses.The more the mother tries to communicate and interact with her baby, the stronger her attachment to her baby.
The baby can be accepted by the mother as an individual, and the attachment between the mother and baby can increase.The early development of safe and positive attachment composes the basis of healthy development.
In the later years of childhood, safe attachment is effective on healthy processes, such as being more positive, establishing close, constructive and respectful relationships, and a high sense of trust, while unsafe attachment is associated with emotional, social, physical and mental psychopathologies.
The mother's touching her baby over her abdomen, trying to guess the parts of the baby, following baby movements, communicating with the baby by focusing and spending private time with the baby increase the physical and psychological contact with the baby.
Fetal movement counting is defined as tracking uninterrupted fetal movements for at least 15-20 minutes by lying on the left side in a calm environment at any time during the day when this baby is awake.
Fetal position tracking is described as trying to guess the parts of the baby by placing the mother's hand on the abdomen.
In the literature, it is stated that prenatal attachment affects postpartum maternal attachment, contributes positively to infant care and provides rapid adaptation to motherhood.
In addition, secure/insecure attachment styles are thought to be associated with postpartum depression.
It is stated that the babies of mothers with strong prenatal attachment show healthier growth and development and even affect their personality positively in adulthood.
In the literature, it is stated that the prenatal period can be an indicator of mother-infant interaction in the postpartum period.This study was carried out as a continuation of the previous study, NCT05313113 Clinical ID, to determine maternal attachment in the postpartum period of pregnant women whose fetal movement and position were followed.
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kayseri̇, Turkey, 38280
- Erciyes University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- literate
- between the ages of 19-35
- Effective communication
- first pregnancy
- having a single fetus
- Pregnancy week between 24 and 28. between the ages of 19-35
- Effective communication
- first pregnancy
- having a single fetus
- Pregnancy week between 24 and 28.
Exclusion Criteria:
- Pregnancy using assisted reproductive techniques
- Having a risky pregnancy (preeclampsia, placenta previa, gestational diabetes etc.)
- Pregnant women with a chronic disease (heart, systemic, circulatory disorder, psychiatric, etc.) were not included in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Arms
Prenatal attachment scale answered.
In the first stage, pregnant women were trained to implement fetal movement count and position tracking.
The training was provided face to face and lasted 30-45 minutes.
How to determine the position of the fetus and I. and II.
Leopold maneuvers are also taught.
In the second stage, the pregnant women were interviewed twice a week by telephone.Thus, it was provided that pregnant women had fetal tracked at least once a day, at any time of the day, when the fetus was awake and most active, in a suitable position and a comfortable environment, for at least 15-20 minutes continuously for four weeks.
Pregnant women phoned the researcher when they wanted.
At the same time, the participants continued to their routine prenatal care.
The mother attachment scale was answered at least 1 month after the birth of the women.
|
In the first stage, pregnant women were trained to implement fetal movement count and position tracking.
The training was provided face to face and lasted 30-45 minutes.
How to determine the position of the fetus and I. and II.
Leopold maneuvers are also taught.
In the second stage, the pregnant women were interviewed twice a week by telephone.Thus, it was provided that pregnant women had fetal tracked at least once a day, at any time of the day, when the fetus was awake and most active, in a suitable position and a comfortable environment, for at least 15-20 minutes continuously for four weeks.
Pregnant women phoned the researcher when they wanted.
At the same time, the participants continued to their routine prenatal care.
|
|
No Intervention: No İntervention Arms
Prenatal attachment scale answered.
The pregnant women continued to their routine prenatal care.
No intervention was applied to the pregnant women in addition to their routine prenatal care.The pregnant women were called about whether continuing their routine care or having any problems during the research.
The mother attachment scale was answered at least 1 month after the birth of the women.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prenatal attachment inventory (PAI)
Time Frame: between 24-28 gestational weeks and after 30 days
|
The mean prenatal attachment level (mean±SD) The mean prenatal attachment was assessed using ''Prenatal attachment inventory''.
The inventory consists of 21 Likert-type items.
Each item is scored between 1 and 4. Therefore, the minimum score of the inventory is 21, while the maximum score of the inventory is 84.
The pregnant between 24-28 gestational weeks were filled with face-to-face interviews at the first interview and 30 days after the training.
[Time Frame: between 24-28 gestational weeks and after 30 days]
|
between 24-28 gestational weeks and after 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal attachment inventory (MAI)
Time Frame: 1-6 months after birth
|
The mean maternal attachment was assessed using ''Maternal attachment inventory (MAI)''.
The inventory consists of 26 Likert-type items.
Each item is scored between 1 and 4. Therefore, the minimum score of the inventory is 26, while the maximum score of the inventory is 104.
A high score indicates high maternal attachment.
The scale can be applied between 1 month and 24 months postpartum.
The scale was answered via telephone.
|
1-6 months after birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aysun BADEM, asst. prof., Erciyes University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 20, 2020
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
December 30, 2020
Study Registration Dates
First Submitted
June 27, 2022
First Submitted That Met QC Criteria
July 1, 2022
First Posted (Actual)
July 5, 2022
Study Record Updates
Last Update Posted (Actual)
July 5, 2022
Last Update Submitted That Met QC Criteria
July 1, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Maternal attachment
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Maternal Behavior
-
Creighton UniversityRecruitingMaternal-Fetal Relations | Maternal BehaviorUnited States
-
Creighton UniversityRecruiting
-
KTO Karatay UniversityKAMİLE ALTUNTUĞCompletedMaternal-Fetal Relations | Maternal BehaviorTurkey
-
Halic UniversityCompletedMaternal Behavior | Maternal Care PatternsTurkey
-
Necmettin Erbakan UniversityNot yet recruitingSelf Efficacy | Maternal Behavior | Maternal Care PatternsTurkey
-
Creighton UniversityCompletedMaternal-Fetal Relations | Maternal Behavior | Paternal BehaviorUnited States
-
Heidemarie LaurentUniversity of Wisconsin, Madison; Mind and Life Institute, Hadley, MassachusettsCompletedNeurobehavioral Effects of Prenatal Mindfulness Training on Maternal Presence and Compassionate LoveMaternal-Fetal Relations | Mother-Child Relations | Maternal BehaviorUnited States
-
Baylor College of MedicineUniversity of IowaCompleted
-
Oslo University HospitalThe Research Council of NorwayCompletedMidwife-led Continuity and Satisfaction With Care - an Observational Case-Control Study in PalestineMaternal BehaviorPalestinian Territory, occupied
-
Johns Hopkins Bloomberg School of Public HealthBill and Melinda Gates FoundationRecruitingMaternal BehaviorEthiopia
Clinical Trials on Fetal movement and position tracking training
-
Institut National de la Santé Et de la Recherche...CompletedHealthy | Parkinson Disease | DystoniaFrance
-
Abant Izzet Baysal UniversityNot yet recruitingFetal Movement | Tele-nursingTurkey (Türkiye)
-
Innodem NeurosciencesNovartis PharmaceuticalsRecruitingMultiple SclerosisCanada
-
Innodem NeurosciencesSyneos HealthCompleted
-
University Hospitals Cleveland Medical CenterRecruitingBipolar DisorderUnited States
-
Innodem NeurosciencesTerminatedNeurological DisordersCanada
-
Innodem NeurosciencesTerminatedCancer-related Cognitive ImpairmentCanada
-
Innodem NeurosciencesCompleted
-
Innodem NeurosciencesCompletedMultiple SclerosisCanada
-
Cairo UniversityRecruiting