Prenatal AttachmentNCT05313113
The Effect of Self-made Fetal Movement and Position Tracking on Prenatal Attachment and Pregnancy Distress
A study testing Experimental in people with Prenatal Attachment and Fetal Position Tracking, run by TC Erciyes University 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 prenatal attachment and prenatal distress. 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
- Prenatal Attachment, Fetal Position Tracking, Distress
- What is being tested?
- Experimental
- 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
- 15 Jul 2019to 20 May 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
- least literate
- between the ages of 19-35
- 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
This study was conducted to determine the effect of self-made fetal movement counting and fetal position tracking on prenatal attachment and prenatal distress.
Read the detailed description
Attachment, which is the basis for establishing social relationships, is the intense feelings that people develop towards the people they consider important. These strong emotions begin with the mother, who is the first person to interact with the individual. When the woman learns that she is pregnant, she becomes curious about her baby, dreams related to the baby, and starts communicating with her baby. Therefore, when baby movements are felt, prenatal attachment becomes stronger, and the cornerstones of attachment are formed.
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. Thus, the baby can be accepted by the mother as an individual, and the attachment between the mother and baby can increase.
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. Thanks to fetal movement and position tracking, the state of fetal health can be determined, mother-baby attachment can be increased, and pregnancy distress can be reduced. Pregnant women also may experience negative emotions because of stress, anxiety, anxious anticipation, deterioration of body perception, adaptation to the new situation, anxiety about being a parent, increasing financial needs, fear of birth, and insufficient social support. Hence pregnancy distress can prevent a pleasant pregnancy period and can cause a negative effect on mother-baby attachment.
In order to increase attachment, mothers can be trained on fetal movement and position tracking. This training can be integrated into routine prenatal care since it can be taught quickly. Moreover, it is helpful and economically viable and providing early recognition of fetal risk.
This study was conducted to determine the effect of self-made fetal movement and position tracking on prenatal attachment and pregnancy distress.
- Conditions
- Prenatal Attachment, Fetal Position Tracking, Distress
- Being tested
- Experimental
- Keywords
- Prenatal attachment, Pregnancy, Fetal Position Tracking, Fetal Movement Count, Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalBehavioural
Pregnant women were trained to implement fetal movement count and position tracking. The training was provided face to face and lasted 30-45 minutes. The training content included topics such as setting a comfortable environment and suitable position for the pregnant, when the fetus is active and asleep during the day, how to count and how to evaluate the movements. 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 group | Experimental | 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. Receives: Behavioral: Experimental |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between 24-28 gestational weeks and after 30 days
The mean pregnancy distress level (mean±SD)
The mean pregnancy distress was assessed using "Pregnancy Distress Scale".The TPDS consists of 16 items and two sub-dimensions as negative affect and partner involvement. The TPDS is 4-point likert type. Each item is scored between 0 and 3. Thus, the total score of TPDS is ranged between 0 and 48 on the scale. The higher the score, the higher the pregnancy distress. The pregnant between 24-28 gestational weeks were filled with face-to-face interviews at the first interview and 30 days after the training.
Measured: between 24-28 gestational weeks and after 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start15 Jul 2019
- Primary completion15 Aug 2019
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prenatal AttachmentStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Responsible party
- Principal investigator, AYSUN BADEM, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313113
- Sponsor's protocol ID
- KKYFHTPBVGDE85
- Status last verified
- Mar 2022
- First submitted
- 7 Feb 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Badem A, Mucuk S. The effect of self-evaluation of foetal movement and position tracking on prenatal attachment and distress. J Reprod Infant Psychol. 2024 Jun;42(3):439-448. doi: 10.1080/02646838.2022.2117290. Epub 2022 Sep 1.
PubMed 36047609
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 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 on Prenatal Attachment and Pregnancy Distress
- ClinicalTrials.gov ID
- NCT05313113
- Acronym / sponsor ID
- KKYFHTPBVGDE85
- Conditions
- Prenatal Attachment, Fetal Position Tracking, Distress
- Keywords
- Prenatal attachment, Pregnancy, Fetal Position Tracking, Fetal Movement Count, Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 6 Apr 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 prenatal attachment and prenatal distress.
Detailed description
Attachment, which is the basis for establishing social relationships, is the intense feelings that people develop towards the people they consider important. These strong emotions begin with the mother, who is the first person to interact with the individual. When the woman learns that she is pregnant, she becomes curious about her baby, dreams related to the baby, and starts communicating with her baby. Therefore, when baby movements are felt, prenatal attachment becomes stronger, and the cornerstones of attachment are formed.
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. Thus, the baby can be accepted by the mother as an individual, and the attachment between the mother and baby can increase.
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. Thanks to fetal movement and position tracking, the state of fetal health can be determined, mother-baby attachment can be increased, and pregnancy distress can be reduced. Pregnant women also may experience negative emotions because of stress, anxiety, anxious anticipation, deterioration of body perception, adaptation to the new situation, anxiety about being a parent, increasing financial needs, fear of birth, and insufficient social support. Hence pregnancy distress can prevent a pleasant pregnancy period and can cause a negative effect on mother-baby attachment.
In order to increase attachment, mothers can be trained on fetal movement and position tracking. This training can be integrated into routine prenatal care since it can be taught quickly. Moreover, it is helpful and economically viable and providing early recognition of fetal risk.
This study was conducted to determine the effect of self-made fetal movement and position tracking on prenatal attachment and pregnancy distress.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: ExperimentalIn 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- least 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 |
|---|---|---|
| ExperimentalPregnant women were trained to implement fetal movement count and position tracking. The training was provided face to face and lasted 30-45 minutes. The training content included topics such as setting a comfortable environment and suitable position for the pregnant, when the fetus is active and asleep during the day, how to count and how to evaluate the movements. 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 group |
Primary outcome
The mean prenatal attachment level (mean±SD)
Time frame: between 24-28 gestational weeks and after 30 days
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.
The mean pregnancy distress level (mean±SD)
Time frame: between 24-28 gestational weeks and after 30 days
The mean pregnancy distress was assessed using "Pregnancy Distress Scale".The TPDS consists of 16 items and two sub-dimensions as negative affect and partner involvement. The TPDS is 4-point likert type. Each item is scored between 0 and 3. Thus, the total score of TPDS is ranged between 0 and 48 on the scale. The higher the score, the higher the pregnancy distress. The pregnant between 24-28 gestational weeks were filled with face-to-face interviews at the first interview and 30 days after the training.
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 2022.
- Derived from this study: PubMed 36047609Badem A, Mucuk S. The effect of self-evaluation of foetal movement and position tracking on prenatal attachment and distress. J Reprod Infant Psychol. 2024 Jun;42(3):439-448. doi: 10.1080/02646838.2022.2117290. Epub 2022 Sep 1.
- 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 Experimental in people with Prenatal Attachment and Fetal Position Tracking, run by TC Erciyes 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 6 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 6 Apr 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?
The mean prenatal attachment level (mean±SD) (time frame: between 24-28 gestational weeks and after 30 days). 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?
On the ClinicalTrials.gov record for NCT05313113, which also lists 1 linked publication.
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 2022.