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Birth OrderNCT06348329

Pregnant Women Participating in Birth Preparation Training With Their Spouses on the Parenting Role, Attitudes of Their Spouses Towards Participating in the Birth, and Birth Self-Efficacy

A study testing Birth Preparation Training in people with Birth Order and Parenting, run by Trakya University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this prospective, randomized controlled study, it was aimed to examine the effect of pregnant women participating in birth preparation training together with their partners on the parenting role, spouses' attitudes towards participation in birth, and birth self-efficacy. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Birth Order, Parenting, Self Efficacy
What is being tested?
Birth Preparation Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 siteTurkey (Türkiye)
Study dates
29 Jun 2023to 15 Dec 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 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Over the age of 18, the mother and the baby must not have any health problems during pregnancy, birth and postpartum period, do not have a previously diagnosed mental disorder, must attend the Birth Preparation Class (BPC) with their spouses for the group receiving co-participation training and continue for 4 weeks. For the education group without partner participation, pregnant women who do not participate in the Birth Preparation Class (BPC) with their partners and continue for 4 weeks and who volunteer to participate in the study will be included in the study.

Who cannot join

  • Under the age of 18, having a health problem in the mother and the baby during pregnancy, birth and postpartum period, having a previously diagnosed mental disorder, not participating in the Birth Preparation Class (BPC) with their spouses for the group receiving training with partner participation and not attending the Birth Preparation Class (DHS) for 4 weeks. For the training group without partner participation, participation in the Birth Preparation Class (BPC) with their spouses and non-attendance for 4 weeks, and non-pregnant women will not be included in the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Trakya University

    Edirne, 22030

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Pregnant Women Participating in Birth Preparation Training With Their Spouses on the Parenting Role, Attitudes of Their Spouses Towards Participating in the Birth, and Birth Self-Efficacy

In this prospective, randomized controlled study, it was aimed to examine the effect of pregnant women participating in birth preparation training together with their partners on the parenting role, spouses' attitudes towards participation in birth, and birth self-efficacy.

The study was shared via the web on social media (Facebook, Instagram, Twitter, Telegram) forum pages between 25.09.2023-25.03.2025, and n=158 pregnant women who met the inclusion criteria and volunteered to participate in the study (79= education without spouse participation, 79= spouse Participatory education) will be conducted randomly in two groups: case and control.

Before starting the research, two groups will be randomly formed among pregnant women. As a randomization method, pregnant women who meet the sampling inclusion criteria determined in the research will be identified and listed. Individuals to be taken into two groups will be determined by randomization method from the random numbers table. (http://www.stattrek.com/statistics/randomnumber-generator.aspx).

Read the detailed description

The study was shared via the web on social media (Facebook, Instagram, Twitter, Telegram) forum pages between 25.09.2023-25.03.2025, and n=158 pregnant women who met the inclusion criteria and volunteered to participate in the study (79= education without spouse participation, 79= spouse Participatory education) will be conducted randomly in two groups: case and control.

Since the study is descriptive in nature, it was calculated that 158 pregnant women should be included in the study in order to determine the scale score regarding the "Spouse Support Scale" score with an 80% effect level, 95% confidence level and 5% margin of error.

Before starting the research, two groups will be randomly formed among pregnant women. As a randomization method, pregnant women who meet the sampling inclusion criteria determined in the research will be identified and listed. Individuals to be taken into two groups will be determined by randomization method from the random numbers table. (http://www.stattrek.com/statistics/randomnumber-generator.aspx).

In the first interview for both groups, "Information Form", "Postpartum Parenting Behavior Scale", "Self-Efficacy Scale in Labor", "Attitude Scale towards Participating in Birth for Expectant Fathers" and "Spouse Support Scale" were given to each participant with information about the study. After the purpose of the study is explained, an e-survey containing survey and scale questions will be used. The e-survey will be arranged so that each participant participates only once. In the first part of the e-survey, information about the study and the purpose of the study will be explained to the pregnant women, and if they confirm that they want to participate, they will begin the second part, the survey questions. Pregnant women assigned to the training group are included in the Birth Preparation Class and taught online for 4 weeks, once a week, for an average of 3 hours a day. They will be asked to participate in the ongoing training with their spouses. All scales will be repeated before training, after training and in the 1st month after birth. Birth Preparation Training will be provided by a certified educator and researcher who has training in the field.

In the study, the "Information Form", "Postpartum Parenting Behavior Scale", "Self-Efficacy in Labor Scale", "Attitude Scale towards Participating in Birth for Expectant Fathers" and "Spouse Support Scale" prepared by the researchers will be used.

Information Form: It was created by researchers by scanning the literature and consists of a total of 28 questions: 15 questions covering the socio-demographic characteristics of pregnant women, 7 questions covering their obstetric characteristics, and 6 questions about their thoughts on labor.

Postnatal Parenting Behavior Scale: It is used to evaluate the parenting behavior of parents towards the baby during their first encounter with their baby after birth. The scale can only be applied to parents in the first minutes after birth. The scale, which consists of items such as close contact, touching with affection, examining the baby, talking with affection, positive comments and happiness, is evaluated in a binary scoring manner by marking these items as present/absent. Each item is evaluated as one (1) point if the behavior is observed, and zero (0) point if the behavior is not observed. The total scale score consists of the sum of the numbers obtained from each item. The total score of the scale is between 0-6 points. A higher total score from the scale indicates that the parent has more positive parenting behavior towards his/her baby.

Self-Efficacy in Labor Scale: The Turkish validity and reliability study of the scale, which measures women's self-confidence and coing ability regarding labor, was conducted. The scale has two sub-dimensions: outcome and competence expectation. Each sub-dimension of the scale consists of 16 questions. The lowest score to be obtained from the scale sub-dimensions is 16 and the highest score is 160. High scores from the subscales indicate that pregnant women have high expectations of adequacy and outcome regarding birth. Responses on a Likert-type scale are scored from 1 to 10. In the outcome expectation sub-dimension of the scale; 1 is "not useful at all", 10 is "very useful", and in the proficiency expectation sub-dimension; The first 13 questions are marked as 1 "completely sure", 10 as "not at all sure", questions 14-16 as 1 "not at all sure", and 10 as "completely sure". Questions 1 to 13 in the proficiency expectation sub-dimension of the scale were scored in reverse order. The lowest total score that can be obtained from the scale is 32, and the highest total score is 320. High scores from the scale indicate that pregnant women have high self-efficacy levels in labor. Cronbach's alpha coefficient of the scale was found to be 0.90.

Spouse Support Scale: The scale developed is used to measure the support spouses receive from each other. The scale consists of a total of 27 questions, and there are 3 reversed items. The scale has a three-point rating; It is shown as Suitable for Me=3, Partially Suitable for Me=2, Not Suitable for Me=1. Just like straight items, reversed items are scored in reverse. The scale has four factors. The first factor is 'emotional support' (6,16,12,21,4,1,3,9,2) consisting of nine items, and the second factor is 'financial aid and information support' (24,17,27,25,13,7, 15) consists of seven items, the third factor 'appreciation support' (18,10,5,26,14,22,23,20) consists of eight items, and the fourth factor 'social interest support' (19,11,8) consists of three items. The score that can be obtained from EDS varies between 27-81. The lower the score, the less support, the higher the score, the more support. The Cronbach Alpha coefficient of the scale is stated as 0.95.

Attitude Scale for Father Candidates Towards Participating in the Birth: The scale is used to evaluate the attitudes of father candidates towards attending the birth. The scale consists of 26 items and is a five-point Likert type. The reactions of the prospective fathers who answered the scale to the items are measured with five options for positive statements, depending on their degree of agreement: completely agree = 5, agree = 4, undecided = 3, disagree = 2, completely disagree = 1. The scale contains 18 positive items and 8 negative items. Negative expressions are coded by reversing. The scale consists of three subscales: Positive Emotions Towards Participating in Birth, Negative Emotions Towards Participating in Birth, and Actions Towards Participating in Birth. The lowest score that can be obtained from the scale is 26 and the highest score is 130. An increase in the total score of the scale indicates that prospective fathers have a more positive attitude towards participating in the birth. The decrease in the total score shows that prospective fathers have a negative attitude towards participating in the birth.

Being tested
Birth Preparation Training
Keywords
Birth Preparation Training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Birth Preparation TrainingOther

    Birth Preparation Training is planned to include a 4-week program by an internationally certified instructor.

Study groups in NCT06348329
Study groupRoleWhat they receive
education without co-participationExperimentalNot described
Receives: Other: Birth Preparation Training
education with co-participationExperimentalNot described
Receives: Other: Birth Preparation Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parenting behavior evaluated using the Postpartum Parenting Behavior Scale

    It is used to evaluate the parenting behavior of parents towards the baby during their first encounter with their baby after birth. The scale can only be applied to parents in the first minutes after birth. Britton et al. It was developed by Çalışır et al. Turkish validity and reliability were conducted by. The scale, which consists of items such as close contact, touching with affection, examining the baby, talking with affection, positive comments and happiness, is evaluated in a binary scoring manner by marking these items as present/absent. Each item is evaluated as one (1) point if the behavior is observed, and zero (0) point if the behavior is not observed. The total scale score consists of the sum of the numbers obtained from each item. The total score of the scale is between 0-6 points. A higher total score from the scale indicates that the parent has more positive parenting behavior towards his/her baby.

    Measured: change from baseline implamentation patent and after training and 1st month after birth of practice

  2. Parenting self-efficacy in labor evaluated using the Self-Efficacy in Labor Scale

    he Turkish validity and reliability study of the scale, which measures women's self-confidence and coping ability regarding labor, was conducted by Ersoy. The scale has two sub-dimensions: outcome and competence expectation. Each sub-dimension of the scale consists of 16 questions. The lowest score to be obtained from the scale sub-dimensions is 16 and the highest score is 160. High scores from the subscales indicate that pregnant women have high expectations of adequacy and outcome regarding birth. Responses on a Likert-type scale are scored from 1 to 10.

    Measured: change from baseline implamentation patent and after training and 1st month after birth of practice

  3. Spouse support evaluated using the Spouse Support Scale

    The scale developed by Yıldırım (2004) is used to measure the support spouses receive from each other. The scale consists of a total of 27 questions, and there are 3 reversed items (10,20,24). The scale has a three-point rating; It is shown as Suitable for Me=3, Partially Suitable for Me=2, Not Suitable for Me=1. Just like straight items, reversed items are scored in reverse. The scale has four factors. The first factor is 'emotional support' (6,16,12,21,4,1,3,9,2) consisting of nine items, and the second factor is 'financial aid and information support' (24,17,27,25,13,7, 15) consists of seven items, the third factor 'appreciation support' (18,10,5,26,14,22,23,20) consists of eight items, and the fourth factor 'social interest support' (19,11,8) consists of three items. The score that can be obtained from EDS varies between 27-81. The lower the score, the less support, the higher the score, the more support. The Cronbach Alpha coefficient of the scale is stated as 0.95.

    Measured: change from baseline implamentation patent and after training and 1st month after birth of practice

  4. Father candidates towards participating in the birth evaluated using the Attitude Scale for Father Candidates Towards Participating in the Birth

    The scale developed by Çiçek Özdemir and Kan in 2022 is used to evaluate the attitudes of father candidates towards attending the birth. The scale consists of 26 items and is a five-point Likert type. The reactions of the prospective fathers who answered the scale to the items are measured with five options for positive statements, depending on their degree of agreement: completely agree = 5, agree = 4, undecided = 3, disagree = 2, completely disagree = 1. The scale contains 18 positive items and 8 negative items. Negative expressions are coded by reversing. The scale consists of three subscales: Positive Emotions Towards Participating in Birth, Negative Emotions Towards Participating in Birth, and Actions Towards Participating in Birth.

    Measured: change from baseline implamentation patent and after training and 1st month after birth of practice

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2024
  2. Study start29 Jun 2023
  3. Primary completion15 Oct 2023
  4. Study completion15 Dec 2024

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06348329
Sponsor's protocol ID
TÜTF-GOBAEK 2023/41
Status last verified
Jan 2025
First submitted
30 Mar 2024
Last updated
30 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Birth Preparation Training in people with Birth Order and Parenting, run by Trakya 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 1 inclusion and 1 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 Jan 2025. 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?

Parenting behavior evaluated using the Postpartum Parenting Behavior Scale (time frame: change from baseline implamentation patent and after training and 1st month after birth of practice). The study lists 4 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 30 Jan 2025.

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