Fear of ChildbirthNCT06344741
Consequences of Admission to the Delivery Room in the Early and Late Phases
An observational study of Fear of Childbirth and Neonatal, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the early (latent) and late (active) phase. The population of the research will consist of participants who applied to Darıca Farabi Training and Research Hospital for birth. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth, Neonatal, Pain
- What is being tested?
- Accepted in latent phase and Accepted in active phase
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 248 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Oct 2023to 31 Jul 2024
- Phase
- Observational
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants who applied to the delivery room during the study period and met the inclusion criteria
Who may be able to join
- Ages 18 and over,
- At term gestational age (37-42 weeks),
- Does not have a risky pregnancy,
- Single pregnancy,
- Head presentation,
- Literate participants will be included
Who cannot join
- Those who do not have sufficient mental health to fill out the survey form,
- Visual, hearing, perception impaired
- The newborn is unhealthy or stillborn,
- With membrane rupture
- Having a history of cesarean section
- Those who have contraindications for vaginal birth
Show all 9Show fewer
- Having complaints of pregnancy-related bleeding,
- Any risk of birth (placental abruption, uterine rupture, etc.)
- Willing to leave at any point during the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Maternal and Neonatal Outcomes of Early and Late Admission to the Delivery Room
This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the early (latent) and late (active) phase. The population of the research will consist of participants who applied to Darıca Farabi Training and Research Hospital for birth. To determine the sample size of the study, first, those who meet the inclusion criteria and are admitted to the delivery room in the latent phase and those who are accepted in the active phase will be numbered and recruited sequentially. When the number of participants in the 100 latent and 100 active acceptance groups is reached, the effect size will be calculated using the STAI score averages and the G*Power program, and the exact sample number will be determined, taking into account possible data losses. If necessary, data collection will continue until the target number is reached. Randomization will not be applied in the study. Data will be collected with the maternal and neonatal information form, State and Trait Anxiety Scale (STAI), Fear of Birth Scale, Neonatal Pain and Stress Assessment Scale (ALPS-Neo) and Visual analog scale for birth satisfaction. Data will be collected by the assistant researcher. Statistical analysis will be performed using IBM SPSS Statistic. Descriptive statistical methods will be used to evaluate socio-demographic data, and parametric/nonparametric tests will be used for comparative analyses.
Read the detailed description
Aim: This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the latent and active phase.
Research hypothesis:
H1.1: There is a statistical difference between the two groups in terms of maternal outcomes of pregnant women who applied to the delivery room in the latent phase and pregnant women who applied in the active phase.
H1.2: There is a statistical difference between the two groups in terms of neonatal outcomes of pregnant women who applied to the delivery room in the latent phase and pregnant women who applied in the active phase.
H0.1: There is no statistical difference between the two groups in terms of maternal outcomes of pregnant women who applied to the delivery room in the latent phase and pregnant women who applied in the active phase.
H0.2: There is no statistical difference between the two groups in terms of neonatal outcomes of pregnant women who applied to the delivery room in the latent phase and pregnant women who applied in the active phase.
Type of Study: This study is a cross-sectional and analytical study planned to compare maternal and neonatal outcomes of pregnant women admitted to the delivery room in the latent and active phases.
The population of the research will consist of participants who applied to Darıca Farabi Training and Research Hospital for birth. To determine the sample size of the study, first, those who meet the inclusion criteria and are admitted to the delivery room in the latent phase and those who are accepted in the active phase will be numbered and recruited sequentially. When the number of participants in the 100 latent and 100 active acceptance groups is reached, the effect size will be calculated using the STAI score averages and the G*Power program, and the exact sample number will be determined, taking into account possible data losses. If necessary, data collection will continue until the target number is reached. Randomization will not be applied in the study.
Data will be collected with the maternal and neonatal information form, State and Trait Anxiety Scale (STAI), Fear of Birth Scale, Neonatal Pain and Stress Assessment Scale (ALPS-Neo).
Maternal and neonatal information form: It was prepared by the researcher within the framework of the literature. The form consists of 49 questions including maternal and neonatal introductory characteristics.
State and Trait Anxiety Inventory (STAI): This scale, developed by Spielberger et al., consists of two subscales: state and continuous, each consisting of 20 questions. It is a Likert-type scale with points between 1 and 4 for each question and can be applied to individuals over the age of 14.
Neonatal pain and stress rating scale (ALPS-Neo): Lundqvist et al. to evaluate pain and stress in premature and term newborns. The Cronbach's alpha coefficient of the scale was reported as 0.95. The scale is a 0-1-2, 3-point Likert-type scale consisting of 5 items in one dimension, including the newborn's facial expression, breathing pattern, tone of the extremities, hand and foot activities, and activity level. Measurements are made by observation. A minimum of 0 and a maximum of 10 points are obtained from the scale. As a result of the evaluation, 3-5 points indicate the presence of mild pain and stress, and more than 5 points indicate the presence of severe pain and stress. The higher the stress and pain, the higher the score.
Fear of Birth Scale: Scale Wijma et al. It was developed to measure fear during birth. The scale is one-dimensional and consists of a total of 10 items. Responses to each item in the scale range from 1 to 10, with 1 indicating "I completely disagree" and 10 indicating "I completely agree". The minimum score that can be obtained from the scale is 10 and the maximum score is 100. A high score from the scale indicates high fear. Five items in the scale (1, 3, 5, 7, and 10) have a positive meaning, and five items (2, 4, 6, 8, and 9) have a negative meaning.
Visual analog scale for birth satisfaction: It consists of 10 cm analog line. How satisfied were you with your birth? 0 was defined as 'I was not satisfied at all' and 10 was defined as 'I was very satisfied'. The participant is asked to mark the appropriate point. It will be filled after birth.
Statistical analysis will be performed using IBM SPSS Statistic. Descriptive statistical methods (number, percentage, mean, standard deviation) will be used in the evaluation of socio-demographic data. When the data is found to be suitable for normal distribution, it will be analyzed with parametric tests (chi-square, T test, etc.) in comparing categorical variables, and when it is not found to be suitable for normal distribution, it will be analyzed with non-parametric tests (Mann-Whitney U Test, Kruskal Wallis, etc.).
- Being tested
- Accepted in latent phase, Accepted in active phase
- Keywords
- Childbirth, Maternal, Phases
- Medical subject headings
- Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accepted in latent phaseBehavioural
Also called Latent phase
Participants admitted to the delivery room in the latent phase will be included. Routine procedures will be performed.
Accepted in active phaseBehavioural
Also called Active phase
Participants admitted to the delivery room in the active phase will be included. Routine procedures will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Latent phase | Participants admitted to the delivery room in the latent phase will be included. Receives: Behavioral: Accepted in latent phase | |
| Active phase | Participants accepted to the delivery room in the active phase will be included. Receives: Behavioral: Accepted in active phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal pain and stress
ALPS-Neo: It is a 3-point Likert type scale consisting of 5 items: facial expression of the newborn, breathing pattern, tone of extremities, hand and foot activities and activity level. Measurements are made through observation. As stress and pain increase, the score obtained also increases. As a result of the evaluation, 3-5 points indicate the presence of mild pain and stress, and above 5 points indicate the presence of serious pain and stress.
Measured: 15th minute after birth
Birth satisfaction
Birth satisfaction will be measured with a 10cm line visual analogue scale. The participant will be asked about her satisfaction with the birth and will be asked to mark his or her satisfaction on a visual analogue scale. The lowest score from the scale is 0, the highest score is 10.
Measured: 5th hour postpartum
Secondary outcomes (2)
Maternal Anxiety
Maternal anxiety will be measured with the State and Trait Anxiety Inventory (STAI) during contraction monitoring. The scale consists of two subscales: state and continuous, each consisting of 20 questions. It is a Likert-type scale with points between 1 and 4 for each question, and can be applied to individuals over the age of 14. The lowest score from each of the scales is 20 points and the highest score is 80 points.
Measured: During the first 10 minutes of the participant's admission to the delivery room
Fear of Birth
It will be measured with the Fear of Birth Scale during contraction follow-up. Responses to each item in the scale range from 1 to 10, with 1 indicating "I completely disagree" and 10 indicating "I completely agree". The minimum score that can be obtained from the scale is 10 and the maximum score is 100. A high score from the scale indicates high fear.
Measured: During the first 10 minutes of the participant's admission to the delivery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start13 Oct 2023
- Primary completion15 Jul 2024
- Study completion31 Jul 2024
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 Fear of ChildbirthStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Dilek Aksoy, Kocaeli University
- Investigators
- Sena Dilek Aksoy, Ph.D., Study director, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344741
- Sponsor's protocol ID
- sdilek6
- Status last verified
- Jun 2024
- First submitted
- 21 Mar 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lundqvist P, Kleberg A, Edberg AK, Larsson BA, Hellstrom-Westas L, Norman E. Development and psychometric properties of the Swedish ALPS-Neo pain and stress assessment scale for newborn infants. Acta Paediatr. 2014 Aug;103(8):833-9. doi: 10.1111/apa.12672. Epub 2014 May 26.
PubMed 24813238
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Maternal and Neonatal Outcomes of Early and Late Admission to the Delivery Room
- ClinicalTrials.gov ID
- NCT06344741
- Acronym / sponsor ID
- sdilek6
- Keywords
- Childbirth, Maternal, Phases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 3 Apr 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.
This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the early (latent) and late (active) phase. The population of the research will consist of participants who applied to Darıca Farabi Training and Research Hospital for birth. To determine the sample size of the study, first, those who meet the inclusion criteria and are admitted to the delivery room in the latent phase and those who are accepted in the active phase will be numbered and recruited sequentially. When the number of participants in the 100 latent and 100 active acceptance groups is reached, the effect size will be calculated using the STAI score averages and the G*Power program, and the exact sample number will be determined, taking into account possible data losses. If necessary, data collection will continue until the target number is reached. Randomization will not be applied in the study. Data will be collected with the maternal and neonatal information form, State and Trait Anxiety Scale (STAI), Fear of Birth Scale, Neonatal Pain and Stress Assessment Scale (ALPS-Neo) and Visual analog scale for birth satisfaction. Data will be collected by the assistant researcher. Statistical analysis will be performed using IBM SPSS Statistic. Descriptive statistical methods will be used to evaluate socio-demographic data, and parametric/nonparametric tests will be used for comparative analyses.
Detailed description
Aim: This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the latent and active phase.
Research hypothesis:
H1.1: There is a statistical difference between the two groups in terms of maternal outcomes of pregnant women who applied to the delivery room in the latent phase and pregnant women who applied in the active phase.
H1.2: There is a statistical difference between the two groups in terms of neonatal outcomes of pregnant women who applied to the delivery room in the latent phase and pregnant women who applied in the active phase.
H0.1: There is no statistical difference between the two groups in terms of maternal outcomes of pregnant women who applied to the delivery room in the latent phase and pregnant women who applied in the active phase.
H0.2: There is no statistical difference between the two groups in terms of neonatal outcomes of pregnant women who applied to the delivery room in the latent phase and pregnant women who applied in the active phase.
Type of Study: This study is a cross-sectional and analytical study planned to compare maternal and neonatal outcomes of pregnant women admitted to the delivery room in the latent and active phases.
The population of the research will consist of participants who applied to Darıca Farabi Training and Research Hospital for birth. To determine the sample size of the study, first, those who meet the inclusion criteria and are admitted to the delivery room in the latent phase and those who are accepted in the active phase will be numbered and recruited sequentially. When the number of participants in the 100 latent and 100 active acceptance groups is reached, the effect size will be calculated using the STAI score averages and the G*Power program, and the exact sample number will be determined, taking into account possible data losses. If necessary, data collection will continue until the target number is reached. Randomization will not be applied in the study.
Data will be collected with the maternal and neonatal information form, State and Trait Anxiety Scale (STAI), Fear of Birth Scale, Neonatal Pain and Stress Assessment Scale (ALPS-Neo).
Maternal and neonatal information form: It was prepared by the researcher within the framework of the literature. The form consists of 49 questions including maternal and neonatal introductory characteristics.
State and Trait Anxiety Inventory (STAI): This scale, developed by Spielberger et al., consists of two subscales: state and continuous, each consisting of 20 questions. It is a Likert-type scale with points between 1 and 4 for each question and can be applied to individuals over the age of 14.
Neonatal pain and stress rating scale (ALPS-Neo): Lundqvist et al. to evaluate pain and stress in premature and term newborns. The Cronbach's alpha coefficient of the scale was reported as 0.95. The scale is a 0-1-2, 3-point Likert-type scale consisting of 5 items in one dimension, including the newborn's facial expression, breathing pattern, tone of the extremities, hand and foot activities, and activity level. Measurements are made by observation. A minimum of 0 and a maximum of 10 points are obtained from the scale. As a result of the evaluation, 3-5 points indicate the presence of mild pain and stress, and more than 5 points indicate the presence of severe pain and stress. The higher the stress and pain, the higher the score.
Fear of Birth Scale: Scale Wijma et al. It was developed to measure fear during birth. The scale is one-dimensional and consists of a total of 10 items. Responses to each item in the scale range from 1 to 10, with 1 indicating "I completely disagree" and 10 indicating "I completely agree". The minimum score that can be obtained from the scale is 10 and the maximum score is 100. A high score from the scale indicates high fear. Five items in the scale (1, 3, 5, 7, and 10) have a positive meaning, and five items (2, 4, 6, 8, and 9) have a negative meaning.
Visual analog scale for birth satisfaction: It consists of 10 cm analog line. How satisfied were you with your birth? 0 was defined as 'I was not satisfied at all' and 10 was defined as 'I was very satisfied'. The participant is asked to mark the appropriate point. It will be filled after birth.
Statistical analysis will be performed using IBM SPSS Statistic. Descriptive statistical methods (number, percentage, mean, standard deviation) will be used in the evaluation of socio-demographic data. When the data is found to be suitable for normal distribution, it will be analyzed with parametric tests (chi-square, T test, etc.) in comparing categorical variables, and when it is not found to be suitable for normal distribution, it will be analyzed with non-parametric tests (Mann-Whitney U Test, Kruskal Wallis, etc.).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latent phase | – | Behavioral: Accepted in latent phaseParticipants admitted to the delivery room in the latent phase will be included. |
| Active phase | – | Behavioral: Accepted in active phaseParticipants accepted to the delivery room in the active phase will be included. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants who applied to the delivery room during the study period and met the inclusion criteria
Key inclusion criteria (6 listed)
- Ages 18 and over,
- At term gestational age (37-42 weeks),
- Does not have a risky pregnancy,
- Single pregnancy,
- Head presentation,
Key exclusion criteria (9 listed)
- Those who do not have sufficient mental health to fill out the survey form,
- Visual, hearing, perception impaired
- The newborn is unhealthy or stillborn,
- With membrane rupture
- Having a history of cesarean section
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 |
|---|---|---|
| Accepted in latent phaseAlso: Latent phaseParticipants admitted to the delivery room in the latent phase will be included. Routine procedures will be performed. | Behavioural | Latent phase |
| Accepted in active phaseAlso: Active phaseParticipants admitted to the delivery room in the active phase will be included. Routine procedures will be performed. | Behavioural | Active phase |
Primary outcome
Neonatal pain and stress
Time frame: 15th minute after birth
ALPS-Neo: It is a 3-point Likert type scale consisting of 5 items: facial expression of the newborn, breathing pattern, tone of extremities, hand and foot activities and activity level. Measurements are made through observation. As stress and pain increase, the score obtained also increases. As a result of the evaluation, 3-5 points indicate the presence of mild pain and stress, and above 5 points indicate the presence of serious pain and stress.
Birth satisfaction
Time frame: 5th hour postpartum
Birth satisfaction will be measured with a 10cm line visual analogue scale. The participant will be asked about her satisfaction with the birth and will be asked to mark his or her satisfaction on a visual analogue scale. The lowest score from the scale is 0, the highest score is 10.
2 secondary outcomes
Maternal Anxiety
Time frame: During the first 10 minutes of the participant's admission to the delivery room
Fear of Birth
Time frame: During the first 10 minutes of the participant's admission to the delivery room
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 30 Dec 2024.
- Background: PubMed 24813238Lundqvist P, Kleberg A, Edberg AK, Larsson BA, Hellstrom-Westas L, Norman E. Development and psychometric properties of the Swedish ALPS-Neo pain and stress assessment scale for newborn infants. Acta Paediatr. 2014 Aug;103(8):833-9. doi: 10.1111/apa.12672. Epub 2014 May 26.
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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.
Sena Dilek Aksoy, Ph.D. study director
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fear of Childbirth and Neonatal, run by Kocaeli 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 9 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 30 Dec 2024. 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?
Neonatal pain and stress (time frame: 15th minute after birth). 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 NCT06344741, 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 30 Dec 2024.