Maternal BehaviorNCT05443152
The Effect of Self-made Fetal Movement and Position Tracking During Pregnancy on Maternal Attachment
A study testing Fetal movement and position tracking training in people with Maternal Behavior and Attachment, run by AYSUN BADEM at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of self-made fetal movement counting and fetal position tracking on maternal attachment in prenatal period. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Behavior, Attachment
- What is being tested?
- Fetal movement and position tracking training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2020to 30 Dec 2020
- 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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- Effective communication
- first pregnancy
- having a single fetus
- Pregnancy week between 24 and 28.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Maternal Behavior, Attachment
- Being tested
- Fetal movement and position tracking training
- Keywords
- Attachment, Pregnancy, Maternal attachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal movement and position tracking trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arms | Experimental | 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. Receives: Behavioral: Fetal movement and position tracking training |
| No İntervention Arms | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Prenatal attachment inventory (PAI)
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]
Measured: between 24-28 gestational weeks and after 30 days
Secondary outcomes (1)
Maternal attachment inventory (MAI)
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.
Measured: 1-6 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start20 May 2020
- Primary completion30 Sep 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal BehaviorStudies 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
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- AYSUN BADEM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AYSUN BADEM, TC Erciyes University
- Investigators
- Aysun BADEM, asst. prof., Principal investigator, ERCİYES UNIVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443152
- Sponsor's protocol ID
- Maternal attachment
- Status last verified
- Jul 2022
- First submitted
- 27 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self-made Fetal Movement and Position Tracking During Pregnancy on Maternal Attachment in the Postpartum Period
- ClinicalTrials.gov ID
- NCT05443152
- Acronym / sponsor ID
- Maternal attachment
- Conditions
- Maternal Behavior, Attachment
- Keywords
- Attachment, Pregnancy, Maternal attachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- AYSUN BADEMUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 5 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.
This study was conducted to determine the effect of self-made fetal movement counting and fetal position tracking on maternal attachment in prenatal period.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arms | Experimental | Behavioral: Fetal movement and position tracking trainingPrenatal 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. |
| No İntervention Arms | No intervention | –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. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- literate
- between the ages of 19-35
- Effective communication
- first pregnancy
- having a single fetus
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Fetal movement and position tracking trainingIn 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. | Behavioural | Experimental Arms |
Primary outcome
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]
1 secondary outcome
Maternal attachment inventory (MAI)
Time frame: 1-6 months after 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 5 Jul 2022.
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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.
Aysun BADEM, asst. prof. principal investigator
ERCİYES UNIVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal movement and position tracking training in people with Maternal Behavior and Attachment, run by AYSUN BADEM 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 10 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 5 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?
Prenatal attachment inventory (PAI) (time frame: between 24-28 gestational weeks and after 30 days). 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 5 Jul 2022.