the Effect of Fetal Movement Count on Prenatal Attachment and Pregnancy DistressNCT05361265
FETAL MOVEMENT COUNTING
A study testing fetal movement counting in people with the Effect of Fetal Movement Count on Prenatal Attachment and Pregnancy Distress, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study aimed to determine the effect of fetal movement counting on prenatal maternal attachment and distress in pregnancy. Methods: This is a quasi-experimental study. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- the Effect of Fetal Movement Count on Prenatal Attachment and Pregnancy Distress
- What is being tested?
- fetal movement counting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 18 Feb 2019
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- being in 28 to 32 gestation weeks
- primigravidity
- at least literate
Who cannot join
- illiteration
- chronic or psychiatric disease
- communication disability (speech, hearing, mental)
- risky pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF FETAL MOVEMENT COUNTING ON PRENATAL MATERNAL ATTACHMENT AND DISTRESS IN PREGNANCY
Purpose: This study aimed to determine the effect of fetal movement counting on prenatal maternal attachment and distress in pregnancy.
Methods: This is a quasi-experimental study. The population of the study consisted of of 60 primigravida pregnant women (30 experimental and 30 control groups) being in 28 to 32 weeks gestation. The Prenatal Attachment Inventory (PAI) and the Tilburg Pregnancy Distress Scale (TPDS) used for data collection. After the pre-tests (28 to 32 weeks gestation), the experimental group were trained about fetal movement counting. The experimental group performed fetal movement counting for at least four to six weeks. The post-tests were filled in 32 to 38 weeks gestation. The control group received only pre-tests and post-test in the same weeks gestation with the experimental group.
Read the detailed description
This is a quasi-experimental study.
The population of the study consisted of pregnant women followed in a State Hospital in the capital city of Turkey in 2019. Power analysis (Sample error: 0.01 and power: 95%) was performed to determine the sample size of the study. In the power analysis, the mean score of the Prenatal Attachment Inventory was 71.88 ± 8.25 [15] and the mean score of the Tilburg Pregnancy Distress Scale was 18.86 ± 7.37 [16]. The minimum number of participants required for each group was 24 (α = 0.05, 1-β = 0.80). To increase the reliability and validity of the study, the study sample consisted of 60 pregnant women (30 experimental and 30 control groups). The criteria for inclusion in the research sample were; being in 28 to 32 weeks gestation, primigravity, being at least literate, not having any chronic or psychiatric disease, not having any communication disability (speech, hearing, mental), non-risky pregnancy (preeclampsia, gestational diabetes, advanced age, and adolescent pregnancy, etc.), current or recent pregnancy is identified as not having any significant life difficulties (loss, illness, accident, etc.). The experimental and control groups were matched to be similar in terms of age, education and working status parameters.
Data Collection Instruments:
Research data were collected using the Descriptive Information Form, the Prenatal Attachment Inventory (PAI), the Tilburg Pregnancy Distress Scale (TPDS) and the Fetal Movement Monitoring Card.
In the Descriptive Information Form, there are five questions including the socio-demographic informations of the pregnant women (age, education status, working status, and perceived income) and the gestational week.
The PAI was developed by Mary Muller (1993) to explain the feelings, thoughts, and situations of women during pregnancy and to determine their attachment levels to the baby in the prenatal period [17]. The scale consists of 21 items in total. In the 4-point Likert scale, each item can score between 1 and 4 points (1: Never, 2: Sometimes, 3: Frequent, 4: Always). The highest score of the scale is 84, the lowest score is 21, and the high scale score indicates the high level of prenatal attachment. The Turkish reliability and validity study of the scale was conducted by Duyan et al. (2013) and the Cronbach Alpha reliability coefficient was found to be 0.78 [18]. In our study, Cronbach Alpha reliability coefficients were; pre-test: 0.851, post-test: 0.811 in the experimental group; pre-test: 0.863, post-test: 0.865 in control group.
The TPDS is developed by Pop et al. (2011) for the diagnosis of distress in pregnancy [11]. The scale consists of a total of 16 items. The scale has two subscales. Negative Affect subscale consists of 12 items including fear, anxiety and negative perceptions regarding pregnancy, childbirth and the postpartum period. Partner Involvement subscale consists of 4 items related to spousal support during pregnancy. The scale is a four-point Likert type and each item is scored between 1 and 3 (0: very often, 1: quite often, 2: sometimes, and 3: rarely or never). The points 3.5,6,7,9,10,11,12,13,14 and 16 are interpreted by reversing them. The highest score of the scale is 48 and the lowest score is 0. A high score from the scale indicates that pregnant women are at risk for distress. The Turkish validity-reliability study of the scale was conducted by Çapık and Pasinlioğlu (2015) and the Cronbach Alpha reliability coefficient was found to be 0.83 [19]. In our study, the Cronbach's alpha reliability coefficient of the scale was 0.836 in the experimental group and 0.826 in the post-test; the control group's pre-test was 0.731 and the post-test was 0.793.
The Fetal Movement Monitoring Card was prepared by the researchers. The card contains instructions on the importance of fetal movement counting and information on how to perform the counting. The card also includes a chart to monitor the fetal movement counting process performed by pregnant women and record the fetal movement counting process and how many movements are counted to check whether the researcher fulfilled the research conditions of the pregnant women.
Procedure:
Ethics committee approval and hospital permissions were obtained for the study. The application was carried out in the pregnant education class of the hospital between 01.11.2018-18.02.2019. It was determined that the pregnant women who participated in the pregnant education class met the research criteria. Written consent was obtained after the pregnant women who met the criteria were informed about the study. The pregnant women were assigned to the experimental and control groups by the researcher. At this stage of the study, all data collection forms were filled out for pregnant women. The forms were completed by the pregnant women themselves in a comfortable environment in a quiet part of the pregnant education class.
Control Group:
When the pregnant women in the control group came to the hospital for follow-up (in 32 to 38 weeks gestation), they were invited to the pregnant education class and the PAI and the TPDS was refilled.
Experimental Group:
After completing the data collection tools, pregnant women were trained about fetal movements and fetal movement counting was taught. The training was given verbally. Pregnant women were asked to perform ten fetal movements by counting once a day after any meal, lying in the left side position for one hour. When ten fetal movements could not be reached within the first hour, pregnant women were instructed to count the fetal movements for one hour after walking for five minutes. When ten fetal movement counts could not be obtained at the end of two hours, they were asked to apply to the hospital immediately. Pregnant women were expected to perform fetal movement counting after the same meal every day (breakfast, lunch or dinner) and record the start and end times of the ten movements on the Fetal Movement Monitoring Card.
In the application of the study, it was ensured that the pregnant women in the experimental group performed fetal movement counting for at least four to six weeks. In this context, pregnant women were called every week to monitor and to motivate them to continue the counting. It was planned to exclude the pregnant women who were informed that they had not performed the application for four consecutive days, withdrew from the study voluntarily, who could not be followed up by telephone, who had significant life distress (death, illness, divorce, accident, etc.), who developed complications in their pregnancy or was diagnosed with risky pregnancy. In this context, one pregnant was excluded from the sample because she gave birth prematurely and two pregnant women did not answer the phone. New pregnant women who met the criteria were included in the sample instead of the pregnant women outside the sample.
When the pregnant women came to the hospital for follow-up (in 32 to 38 weeks gestation), they were invited to the pregnant education class. After confirming that the women had performed the application by checking the Fetal Movement Monitoring Cards, the API and the TPDS were refilled.
- Being tested
- fetal movement counting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fetal movement countingOther
pregnant women were trained about fetal movements and fetal movement counting was taught. Pregnant women were asked to perform ten fetal movements by counting once a day. In the application of the study, it was ensured that the pregnant women in the experimental group performed fetal movement counting for at least four to six weeks. In this context, pregnant women were called every week to monitor and to motivate them to continue the counting.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | pregnant women were trained about fetal movements and fetal movement counting was taught. The training was given verbally. Pregnant women were asked to perform ten fetal movements by counting once a day after any meal, lying in the left side position for one hour. When ten fetal movements could not be reached within the first hour, pregnant women were instructed to count the fetal movements for one hour after walking for five minutes. When ten fetal movement counts could not be obtained at the end of two hours, they were asked to apply to the hospital immediately. Pregnant women were expected to perform fetal movement counting after the same meal every day (breakfast, lunch or dinner) and record the start and end times of the ten movements on the Fetal Movement Monitoring Card. Receives: Other: fetal movement counting |
| Control Group | No intervention | Routine follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
prenatal maternal attachment
the Prenatal Attachment Inventory: The inventory was developed to explain the feelings, thoughts, and situations of women during pregnancy and to determine their attachment levels to the baby in the prenatal period [17]. The scale consists of 21 items in total. In the 4-point Likert scale, each item can score between 1 and 4 points (1: Never, 2: Sometimes, 3: Frequent, 4: Always). The highest score of the scale is 84, the lowest score is 21, and the high scale score indicates the high level of prenatal attachment.
Measured: 4-6 weeks
distress in pregnancy
the Tilburg Pregnancy Distress Scale: The scale was developed for the diagnosis of distress in pregnancy [11]. The scale consists of a total of 16 items. The scale has two subscales. Negative Affect subscale consists of 12 items including fear, anxiety and negative perceptions regarding pregnancy, childbirth and the postpartum period. Partner Involvement subscale consists of 4 items related to spousal support during pregnancy. The scale is a four-point Likert type and each item is scored between 1 and 3 (0: very often, 1: quite often, 2: sometimes, and 3: rarely or never). The points 3.5,6,7,9,10,11,12,13,14 and 16 are interpreted by reversing them. The highest score of the scale is 48 and the lowest score is 0. A high score from the scale indicates that pregnant women are at risk for distress.
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Nov 2018
- Primary completion18 Feb 2019
- Study completion18 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Effect of Fetal Movement Count on Prenatal Attachment and Pregnancy DistressStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şengül Yaman Sözbir, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361265
- Sponsor's protocol ID
- HulyaAydin
- Status last verified
- Apr 2022
- First submitted
- 29 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF FETAL MOVEMENT COUNTING ON PRENATAL MATERNAL ATTACHMENT AND DISTRESS IN PREGNANCY
- ClinicalTrials.gov ID
- NCT05361265
- Acronym / sponsor ID
- HulyaAydin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 4 May 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.
Purpose: This study aimed to determine the effect of fetal movement counting on prenatal maternal attachment and distress in pregnancy.
Methods: This is a quasi-experimental study. The population of the study consisted of of 60 primigravida pregnant women (30 experimental and 30 control groups) being in 28 to 32 weeks gestation. The Prenatal Attachment Inventory (PAI) and the Tilburg Pregnancy Distress Scale (TPDS) used for data collection. After the pre-tests (28 to 32 weeks gestation), the experimental group were trained about fetal movement counting. The experimental group performed fetal movement counting for at least four to six weeks. The post-tests were filled in 32 to 38 weeks gestation. The control group received only pre-tests and post-test in the same weeks gestation with the experimental group.
Detailed description
This is a quasi-experimental study.
The population of the study consisted of pregnant women followed in a State Hospital in the capital city of Turkey in 2019. Power analysis (Sample error: 0.01 and power: 95%) was performed to determine the sample size of the study. In the power analysis, the mean score of the Prenatal Attachment Inventory was 71.88 ± 8.25 [15] and the mean score of the Tilburg Pregnancy Distress Scale was 18.86 ± 7.37 [16]. The minimum number of participants required for each group was 24 (α = 0.05, 1-β = 0.80). To increase the reliability and validity of the study, the study sample consisted of 60 pregnant women (30 experimental and 30 control groups). The criteria for inclusion in the research sample were; being in 28 to 32 weeks gestation, primigravity, being at least literate, not having any chronic or psychiatric disease, not having any communication disability (speech, hearing, mental), non-risky pregnancy (preeclampsia, gestational diabetes, advanced age, and adolescent pregnancy, etc.), current or recent pregnancy is identified as not having any significant life difficulties (loss, illness, accident, etc.). The experimental and control groups were matched to be similar in terms of age, education and working status parameters.
Data Collection Instruments:
Research data were collected using the Descriptive Information Form, the Prenatal Attachment Inventory (PAI), the Tilburg Pregnancy Distress Scale (TPDS) and the Fetal Movement Monitoring Card.
In the Descriptive Information Form, there are five questions including the socio-demographic informations of the pregnant women (age, education status, working status, and perceived income) and the gestational week.
The PAI was developed by Mary Muller (1993) to explain the feelings, thoughts, and situations of women during pregnancy and to determine their attachment levels to the baby in the prenatal period [17]. The scale consists of 21 items in total. In the 4-point Likert scale, each item can score between 1 and 4 points (1: Never, 2: Sometimes, 3: Frequent, 4: Always). The highest score of the scale is 84, the lowest score is 21, and the high scale score indicates the high level of prenatal attachment. The Turkish reliability and validity study of the scale was conducted by Duyan et al. (2013) and the Cronbach Alpha reliability coefficient was found to be 0.78 [18]. In our study, Cronbach Alpha reliability coefficients were; pre-test: 0.851, post-test: 0.811 in the experimental group; pre-test: 0.863, post-test: 0.865 in control group.
The TPDS is developed by Pop et al. (2011) for the diagnosis of distress in pregnancy [11]. The scale consists of a total of 16 items. The scale has two subscales. Negative Affect subscale consists of 12 items including fear, anxiety and negative perceptions regarding pregnancy, childbirth and the postpartum period. Partner Involvement subscale consists of 4 items related to spousal support during pregnancy. The scale is a four-point Likert type and each item is scored between 1 and 3 (0: very often, 1: quite often, 2: sometimes, and 3: rarely or never). The points 3.5,6,7,9,10,11,12,13,14 and 16 are interpreted by reversing them. The highest score of the scale is 48 and the lowest score is 0. A high score from the scale indicates that pregnant women are at risk for distress. The Turkish validity-reliability study of the scale was conducted by Çapık and Pasinlioğlu (2015) and the Cronbach Alpha reliability coefficient was found to be 0.83 [19]. In our study, the Cronbach's alpha reliability coefficient of the scale was 0.836 in the experimental group and 0.826 in the post-test; the control group's pre-test was 0.731 and the post-test was 0.793.
The Fetal Movement Monitoring Card was prepared by the researchers. The card contains instructions on the importance of fetal movement counting and information on how to perform the counting. The card also includes a chart to monitor the fetal movement counting process performed by pregnant women and record the fetal movement counting process and how many movements are counted to check whether the researcher fulfilled the research conditions of the pregnant women.
Procedure:
Ethics committee approval and hospital permissions were obtained for the study. The application was carried out in the pregnant education class of the hospital between 01.11.2018-18.02.2019. It was determined that the pregnant women who participated in the pregnant education class met the research criteria. Written consent was obtained after the pregnant women who met the criteria were informed about the study. The pregnant women were assigned to the experimental and control groups by the researcher. At this stage of the study, all data collection forms were filled out for pregnant women. The forms were completed by the pregnant women themselves in a comfortable environment in a quiet part of the pregnant education class.
Control Group:
When the pregnant women in the control group came to the hospital for follow-up (in 32 to 38 weeks gestation), they were invited to the pregnant education class and the PAI and the TPDS was refilled.
Experimental Group:
After completing the data collection tools, pregnant women were trained about fetal movements and fetal movement counting was taught. The training was given verbally. Pregnant women were asked to perform ten fetal movements by counting once a day after any meal, lying in the left side position for one hour. When ten fetal movements could not be reached within the first hour, pregnant women were instructed to count the fetal movements for one hour after walking for five minutes. When ten fetal movement counts could not be obtained at the end of two hours, they were asked to apply to the hospital immediately. Pregnant women were expected to perform fetal movement counting after the same meal every day (breakfast, lunch or dinner) and record the start and end times of the ten movements on the Fetal Movement Monitoring Card.
In the application of the study, it was ensured that the pregnant women in the experimental group performed fetal movement counting for at least four to six weeks. In this context, pregnant women were called every week to monitor and to motivate them to continue the counting. It was planned to exclude the pregnant women who were informed that they had not performed the application for four consecutive days, withdrew from the study voluntarily, who could not be followed up by telephone, who had significant life distress (death, illness, divorce, accident, etc.), who developed complications in their pregnancy or was diagnosed with risky pregnancy. In this context, one pregnant was excluded from the sample because she gave birth prematurely and two pregnant women did not answer the phone. New pregnant women who met the criteria were included in the sample instead of the pregnant women outside the sample.
When the pregnant women came to the hospital for follow-up (in 32 to 38 weeks gestation), they were invited to the pregnant education class. After confirming that the women had performed the application by checking the Fetal Movement Monitoring Cards, the API and the TPDS were refilled.
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 | Other: fetal movement countingpregnant women were trained about fetal movements and fetal movement counting was taught. The training was given verbally. Pregnant women were asked to perform ten fetal movements by counting once a day after any meal, lying in the left side position for one hour. When ten fetal movements could not be reached within the first hour, pregnant women were instructed to count the fetal movements for one hour after walking for five minutes. When ten fetal movement counts could not be obtained at the end of two hours, they were asked to apply to the hospital immediately. Pregnant women were expected to perform fetal movement counting after the same meal every day (breakfast, lunch or dinner) and record the start and end times of the ten movements on the Fetal Movement Monitoring Card. |
| Control Group | No intervention | –Routine follow up |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- being in 28 to 32 gestation weeks
- primigravidity
- at least literate
Key exclusion criteria (4 listed)
- illiteration
- chronic or psychiatric disease
- communication disability (speech, hearing, mental)
- risky pregnancy
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 countingpregnant women were trained about fetal movements and fetal movement counting was taught. Pregnant women were asked to perform ten fetal movements by counting once a day. In the application of the study, it was ensured that the pregnant women in the experimental group performed fetal movement counting for at least four to six weeks. In this context, pregnant women were called every week to monitor and to motivate them to continue the counting. | Other | Experimental Group |
Primary outcome
prenatal maternal attachment
Time frame: 4-6 weeks
the Prenatal Attachment Inventory: The inventory was developed to explain the feelings, thoughts, and situations of women during pregnancy and to determine their attachment levels to the baby in the prenatal period [17]. The scale consists of 21 items in total. In the 4-point Likert scale, each item can score between 1 and 4 points (1: Never, 2: Sometimes, 3: Frequent, 4: Always). The highest score of the scale is 84, the lowest score is 21, and the high scale score indicates the high level of prenatal attachment.
distress in pregnancy
Time frame: 4-6 weeks
the Tilburg Pregnancy Distress Scale: The scale was developed for the diagnosis of distress in pregnancy [11]. The scale consists of a total of 16 items. The scale has two subscales. Negative Affect subscale consists of 12 items including fear, anxiety and negative perceptions regarding pregnancy, childbirth and the postpartum period. Partner Involvement subscale consists of 4 items related to spousal support during pregnancy. The scale is a four-point Likert type and each item is scored between 1 and 3 (0: very often, 1: quite often, 2: sometimes, and 3: rarely or never). The points 3.5,6,7,9,10,11,12,13,14 and 16 are interpreted by reversing them. The highest score of the scale is 48 and the lowest score is 0. A high score from the scale indicates that pregnant women are at risk for distress.
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 4 May 2022.
- Individual participant dataSharing planned: No
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 fetal movement counting in people with the Effect of Fetal Movement Count on Prenatal Attachment and Pregnancy Distress, run by Gazi 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 3 inclusion and 4 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 4 May 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 maternal attachment (time frame: 4-6 weeks). 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?
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 4 May 2022.