Fetal MovementNCT06558162
The Effect of Two Different Self-Assessment Methods for Fetal Movement Monitoring on Maternal Psychosocial Status
A study testing Mindfetalness and Sadovsky in people with Fetal Movement and Mental Health Issue, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
Antenatal care is essential for a successful delivery, a healthy baby and a happy mother. The main aim of antenatal care is to take appropriate interventions to assess, protect and improve maternal and fetal health during pregnancy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Movement, Mental Health Issue
- What is being tested?
- Mindfetalness and Sadovsky
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Mar 2024to 20 Jun 2024
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Volunteering to participate in the research
- Over 18 years of age
- Single pregnancy
- Being between 28-32 weeks of gestation
- Primiparity
- At least primary school graduation
- No diagnosed problems related to the health of the fetus (such as fetal anomaly, intrauterine growth retardation) No risky pregnancy (such as pre-eclampsia, diabetes, heart disease, placenta previa, oligohydramnios)
Who cannot join
- Not having any disabilities that may prevent communication (speech, hearing, mental)
- No chronic or psychiatric illness
- Conception with assisted reproductive techniques
Trial locations and contacts
1 site in 1 country.
About this study
Antenatal care is essential for a successful delivery, a healthy baby and a happy mother. The main aim of antenatal care is to take appropriate interventions to assess, protect and improve maternal and fetal health during pregnancy. There are many methods to assess fetal health during pregnancy, such as ultrasonography (USG) and non stress test (NST). Along with these methods, maternal perception and counting of fetal movements is the only method that can be easily used by the mother without the need for clinicians or equipment. When a pregnant woman begins to feel fetal movements, it is one of the first signs of fetal life and is considered an indicator of fetal well-being. Decrease or absence of fetal movements has been stated to be an important parameter in the assessment of fetal health and may be associated with the risk of intrauterine fetal death. Therefore, feeling and counting of fetal movements is the basis for the assessment of fetal health.
Read the detailed description
Two methods are recommended for the identification of fetal movements. These are the Cardiff method and the Sadovsky method. In the assessment of fetal health, not only the number of movements per unit of time is important, but also the strength and nature of these movements. To take this into account, in 2012 Radestad introduced another method of observing the character of the movement, called "Mindfetalness". The method is based on women who develop maternal awareness of the health of the foetus and note the quality of the perceived movements. The method requires the mother to lie on her left side while her baby is awake and focus for 15 minutes on exactly how the baby is moving, taking into account the strength, type and frequency of movement. However, the number of fetal movements is not counted during this time period. This method, which helps women to note fetal movements in order to minimise and/or eliminate adverse birth outcomes, is also reported to cause unnecessary stress to the mother, as with other methods.Although there are studies reporting that counting fetal movements contributes to maternal attachment by increasing the possibility of connecting with the unborn baby, there are also studies that found no difference in maternal-fetal attachment scores. However, it is thought that focusing on the quality rather than the quantity of movements will increase the opportunity to connect with the fetus.
There is no previous comparison in the literature between a self-assessment method that focuses on qualitative variables and a counting method to measure fetal movements. Although there is one study that used both methods, this study did not differentiate between experimental and control groups, but used the crossover method and tested both methods on the same pregnant women. Therefore, our study was planned to determine the effect of fetal movement counting with two different self-assessment methods on prenatal attachment and psychosocial status.
- Conditions
- Fetal Movement, Mental Health Issue
- Being tested
- Mindfetalness, Sadovsky
- Keywords
- pregnancy, fetal movements, mindfetalness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfetalnessBehavioural
They will be instructed to lie on their left side and focus on the fetal movements for 15 minutes every day while the foetus is awake. They will also be instructed to monitor the character, strength and frequency of fetal movements (not to count them) and to seek medical advice if they feel any change in this pattern.
After two weeks, the pregnant women will be invited back to the organisation for a follow-up interview to check whether they have performed the practice and recorded correctly. An interview will be conducted again after four weeks.
SadovskyBehavioural
They will be asked to continue this procedure every morning, noon or evening for one month (depending on the movements of the pregnant woman and her baby, the time will be left to the pregnant woman, but it should be at the same time every day). Since the aim of the study is to increase maternal awareness rather than to determine fetal well-being, mothers will be asked to count at least 10 movements based on the "count to ten" and "Sadovsky" method, and will be asked to record the start and completion time of the movements each time. A follow-up will be made after two weeks and a final follow-up will be made after one month
| Study group | Role | What they receive |
|---|---|---|
| Mindfetalness Group | Experimental | The method is based on noting the quality of perceived movements, which develops maternal awareness of the health of the foetus. The method requires the mother to lie on her left side while her baby is awake and for 15 minutes focus on exactly how the baby moves, taking into account the strength, type and frequency of movement. However, the number of fetal movements is not counted during this time.
It is also very important to understand the attitudes of the pregnant women, because a positive attitude may improve the perception of the pregnant woman and thus increase compliance with the method, whereas a negative attitude may hinder compliance with the method. Therefore, it will be important to create a positive attitude during the counselling of pregnant women in this group. Receives: Behavioral: Mindfetalness |
| Sadovsky Group | Active comparator | This method involves counting the movements over a set period of time (usually 30 minutes to 2 hours). The mother should count the fetal movements at the same time every day. In this counting technique, mothers are especially asked to count after 3 meals during the day. Fetal movements are usually active in the evening. During the counting process, the mother should make sure that the baby is awake and should be calm, resting, eating, using the toilet, lying on her side and placing her hands on her abdomen. When the mother perceives the first movement of the baby, she should start recording on the monitoring chart given to her and continue counting and recording until the 10th movement is completed. If she counts less than 10 movements in the first 30 minutes, she should continue recording. Receives: Behavioral: Sadovsky |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attachment
Prenatal Maternal Attachment Scale: Each item of the scale, which has a total of 19 items, focuses on the feelings, attitudes and behaviors of the pregnant woman towards the fetus. The scale is Likert-type and each item is scored between 1-5. Before the total score is calculated, 11 items in the scale are scored in the reverse direction. The total score for the scale is obtained by adding the scores given to all items. A high score indicates a high degree of attachment.
Measured: Pretest, Follow-up after two weeks, Follow-up after four weeks
Stress
Perceived Stress Scale-10: The ASÖ-10 is a two-factor, with each item being rated on a 5-point Likert-type scale with response options ranging from 0 (never) to 4 (very often). The responses are reversed and the scores of the four positive items are summed over the 10 items to obtain a total score. This score ranges from 0 to 40, with higher scores indicating higher perceived stress.
Measured: Pretest, Follow-up after two weeks, Follow-up after four weeks
Anxiety
State-Trait Anxiety Inventory: It consists of a total of forty items, including a State Anxiety Scale consisting of twenty items and a Trait Anxiety Scale consisting of twenty items. There are two types of expressions in the scales: direct and reversed. The total score obtained from each scale is between a minimum of 20 and a maximum of 80. A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety.
Measured: Pretest, Follow-up after two weeks, Follow-up after four weeks
Secondary outcomes (1)
Risk perception
Risk Perception in Pregnancy Scale: It consists of nine items and 2 factors. There is a 0-100 mm linear line immediately below each item on the scale, indicating "no risk" and "extremely high risk". The total score of the scale is found by adding the scores for each of the nine items and dividing the resulting score by 9. The scale has no cut-off point. As the score obtained from the scale increases, it is accepted that the perception of risk related to the pregnant woman and her baby increases.
Measured: Pretest, Follow-up after two weeks, Follow-up after four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start6 Mar 2024
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal MovementStudies 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
- Model description
- Pregnant women included in the study were randomized into two groups. One group will have fetal movements assessed using the Sadovsky method. The other group will use the Mindfetalness method.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neriman Guducu, Kırklareli University
- Investigators
- Neriman Güdücü, Dr., Study director, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558162
- Sponsor's protocol ID
- PR0478R1
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No such plans have been made as the work is still in progress
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Self-Assessment Methods for Fetal Movement Monitoring on Maternal Psychosocial Status
- ClinicalTrials.gov ID
- NCT06558162
- Acronym / sponsor ID
- PR0478R1
- Conditions
- Fetal Movement, Mental Health Issue
- Keywords
- pregnancy, fetal movements, mindfetalness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 16 Aug 2024 (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.
Antenatal care is essential for a successful delivery, a healthy baby and a happy mother. The main aim of antenatal care is to take appropriate interventions to assess, protect and improve maternal and fetal health during pregnancy. There are many methods to assess fetal health during pregnancy, such as ultrasonography (USG) and non stress test (NST). Along with these methods, maternal perception and counting of fetal movements is the only method that can be easily used by the mother without the need for clinicians or equipment. When a pregnant woman begins to feel fetal movements, it is one of the first signs of fetal life and is considered an indicator of fetal well-being. Decrease or absence of fetal movements has been stated to be an important parameter in the assessment of fetal health and may be associated with the risk of intrauterine fetal death. Therefore, feeling and counting of fetal movements is the basis for the assessment of fetal health.
Detailed description
Two methods are recommended for the identification of fetal movements. These are the Cardiff method and the Sadovsky method. In the assessment of fetal health, not only the number of movements per unit of time is important, but also the strength and nature of these movements. To take this into account, in 2012 Radestad introduced another method of observing the character of the movement, called "Mindfetalness". The method is based on women who develop maternal awareness of the health of the foetus and note the quality of the perceived movements. The method requires the mother to lie on her left side while her baby is awake and focus for 15 minutes on exactly how the baby is moving, taking into account the strength, type and frequency of movement. However, the number of fetal movements is not counted during this time period. This method, which helps women to note fetal movements in order to minimise and/or eliminate adverse birth outcomes, is also reported to cause unnecessary stress to the mother, as with other methods.Although there are studies reporting that counting fetal movements contributes to maternal attachment by increasing the possibility of connecting with the unborn baby, there are also studies that found no difference in maternal-fetal attachment scores. However, it is thought that focusing on the quality rather than the quantity of movements will increase the opportunity to connect with the fetus.
There is no previous comparison in the literature between a self-assessment method that focuses on qualitative variables and a counting method to measure fetal movements. Although there is one study that used both methods, this study did not differentiate between experimental and control groups, but used the crossover method and tested both methods on the same pregnant women. Therefore, our study was planned to determine the effect of fetal movement counting with two different self-assessment methods on prenatal attachment and psychosocial status.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Pregnant women included in the study were randomized into two groups. One group will have fetal movements assessed using the Sadovsky method. The other group will use the Mindfetalness method.
| Arm | Type | Receives |
|---|---|---|
| Mindfetalness Group | Experimental | Behavioral: MindfetalnessThe method is based on noting the quality of perceived movements, which develops maternal awareness of the health of the foetus. The method requires the mother to lie on her left side while her baby is awake and for 15 minutes focus on exactly how the baby moves, taking into account the strength, type and frequency of movement. However, the number of fetal movements is not counted during this time. It is also very important to understand the attitudes of the pregnant women, because a positive attitude may improve the perception of the pregnant woman and thus increase compliance with the method, whereas a negative attitude may hinder compliance with the method. Therefore, it will be important to create a positive attitude during the counselling of pregnant women in this group. |
| Sadovsky Group | Active comparator | Behavioral: SadovskyThis method involves counting the movements over a set period of time (usually 30 minutes to 2 hours). The mother should count the fetal movements at the same time every day. In this counting technique, mothers are especially asked to count after 3 meals during the day. Fetal movements are usually active in the evening. During the counting process, the mother should make sure that the baby is awake and should be calm, resting, eating, using the toilet, lying on her side and placing her hands on her abdomen. When the mother perceives the first movement of the baby, she should start recording on the monitoring chart given to her and continue counting and recording until the 10th movement is completed. If she counts less than 10 movements in the first 30 minutes, she should continue recording. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteering to participate in the research
- Over 18 years of age
- Single pregnancy
- Being between 28-32 weeks of gestation
- Primiparity
Key exclusion criteria (3 listed)
- Not having any disabilities that may prevent communication (speech, hearing, mental)
- No chronic or psychiatric illness
- Conception with assisted reproductive techniques
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 |
|---|---|---|
| MindfetalnessThey will be instructed to lie on their left side and focus on the fetal movements for 15 minutes every day while the foetus is awake. They will also be instructed to monitor the character, strength and frequency of fetal movements (not to count them) and to seek medical advice if they feel any change in this pattern. After two weeks, the pregnant women will be invited back to the organisation for a follow-up interview to check whether they have performed the practice and recorded correctly. An interview will be conducted again after four weeks. | Behavioural | Mindfetalness Group |
| SadovskyThey will be asked to continue this procedure every morning, noon or evening for one month (depending on the movements of the pregnant woman and her baby, the time will be left to the pregnant woman, but it should be at the same time every day). Since the aim of the study is to increase maternal awareness rather than to determine fetal well-being, mothers will be asked to count at least 10 movements based on the "count to ten" and "Sadovsky" method, and will be asked to record the start and completion time of the movements each time. A follow-up will be made after two weeks and a final follow-up will be made after one month | Behavioural | Sadovsky Group |
Primary outcome
Attachment
Time frame: Pretest, Follow-up after two weeks, Follow-up after four weeks
Prenatal Maternal Attachment Scale: Each item of the scale, which has a total of 19 items, focuses on the feelings, attitudes and behaviors of the pregnant woman towards the fetus. The scale is Likert-type and each item is scored between 1-5. Before the total score is calculated, 11 items in the scale are scored in the reverse direction. The total score for the scale is obtained by adding the scores given to all items. A high score indicates a high degree of attachment.
Stress
Time frame: Pretest, Follow-up after two weeks, Follow-up after four weeks
Perceived Stress Scale-10: The ASÖ-10 is a two-factor, with each item being rated on a 5-point Likert-type scale with response options ranging from 0 (never) to 4 (very often). The responses are reversed and the scores of the four positive items are summed over the 10 items to obtain a total score. This score ranges from 0 to 40, with higher scores indicating higher perceived stress.
Anxiety
Time frame: Pretest, Follow-up after two weeks, Follow-up after four weeks
State-Trait Anxiety Inventory: It consists of a total of forty items, including a State Anxiety Scale consisting of twenty items and a Trait Anxiety Scale consisting of twenty items. There are two types of expressions in the scales: direct and reversed. The total score obtained from each scale is between a minimum of 20 and a maximum of 80. A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety.
1 secondary outcome
Risk perception
Time frame: Pretest, Follow-up after two weeks, Follow-up after four weeks
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 Aug 2026.
- Individual participant dataSharing planned: No. No such plans have been made as the work is still in progress
Related trials for Fetal Movement
RecruitingObservational study
Feasibility Trial of the Womb Watch Smartphone App To Assess Fetal Movements
Assessment of Fetal Movement, Pregnancy
Recruiting
Tele-Nursing-Supported Mindfetalness: Anxiety and Prenatal Attachment
Tele-nursing, Fetal Movement
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.
Neriman Güdücü, Dr. study director
Kırklareli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfetalness and Sadovsky in people with Fetal Movement and Mental Health Issue, run by Kırklareli 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 7 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 Aug 2026. 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?
Attachment (time frame: Pretest, Follow-up after two weeks, Follow-up after four weeks). The study lists 3 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 5 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.