Gaining the Role of Motherhood in Primipara Pregnancy (Focus)NCT05017909
The Effect of Different Education Techniques on the Acquisition of the Mothering Role
A study testing Face to face education, Web based education and No education in people with Gaining the Role of Motherhood in Primipara Pregnancy (Focus), run by Hasan Kalyoncu University.
Trial summary
The research consists of two stages. First Stage: It is the development of the scale for gaining the role of motherhood in primiparas according to the scale development stages. In order to define the subject and determine the scope, the content analysis will be determined by interviewing the sample group that will not… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gaining the Role of Motherhood in Primipara Pregnancy (Focus)
- What is being tested?
- Face to face education, Web based education and No education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Sep 2022
- 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
- Having a primiparous pregnancy,
- In the last trimester of pregnancy,
- At least primary school graduate,
- Able to read and understand Turkish,
- Use the internet actively and regularly access the website and receive training,
- Do not have any physical, mental or social problems that may prevent participation in face-to-face or web-based education and pregnant women who accepted the study will be included in the study.
Who cannot join
- Pregnant women who cannot access the website,
- Have any congenital defect in their baby,
- Experience mother-baby separation,
- Want to leave the research before the end of the research will not be included in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Education Given to Primipara Pregnancy With Two Different Methods (Face-To-Face/ Web-Based) in the Last Trimester on Their Acquisition of the Mothering Role
The research consists of two stages.
First Stage: It is the development of the scale for gaining the role of motherhood in primiparas according to the scale development stages. In order to define the subject and determine the scope, the content analysis will be determined by interviewing the sample group that will not be included in the pilot application and the final scale application and the primipara people with similar characteristics. As a result, the item pool will form the basis together with the literature. An item pool related to gaining the role of motherhood will be created, the opinions of experts will be taken to evaluate the scope and appearance validity of the scale, and adjustments will be made in the item pool according to expert opinions.
Read more
In order to determine the validity and reliability of the scale, half of the participants will be tested-retested. The internal consistency reliability of the scale will be determined by the Cronbach Alpha reliability coefficient. In addition, Edinburgh Postpartum Depression Scale (EDDS) and Mother-Infant Attachment Scale (MIAS), which are similar scales, will be used in the scale development phase for the validity of the scale.
Second stage: The training consisting of 3 modules is planned. MODULE: Mother Module MODULE: Infant Module MODULE: Breastfeeding Module
At this stage of the study, pregnant women who meet the sampling criteria will be divided into groups. The determination of the groups will be according to the Randomized numbers table. Pregnant women who will enter the web-based training group (Experimental group 1), Face-to-face training group (Experimental group 2) and the control group will be determined.
The personal information form containing the socio-demographic data and the final scale developed to gain the role of motherhood in primiparas will be applied to the participants who volunteered to participate in the study.
Experimental Initiative: A web-based and face-to-face training program will be planned and implemented as separate groups for the sampled participants.
Post-Test Application of the Final Scale: The final scale, which was developed to gain the role of motherhood in primiparas, will be administered to the participants in the sample group as a post-test on the 40th day.
By analyzing the data obtained, the effectiveness of the scale and the difference between the pre-test scores of the participant group after the training program will be examined.
Read the detailed description
The research was planned methodologically and experimentally. A motherhood role acquisition scale will be developed as a methodological study, and web-based and face-to-face training will be given experimentally. The effect of the training given on the acquisition of the role of mother will be determined.
The research will be conducted between September 2021 and September 2022.
The Universe and Sample of the Research; the population of the research will be all primiparous pregnant women who meet the criteria for participation in the study and volunteer to participate in the study in two different Family Health Centers (FHC) affiliated to Gaziantep Provincial Health Directorate and Private Dr. Tuncay Yüce Gynecology and Obstetrics Clinic.
The sample of the first stage of the research; determined by the number of items in the scale. When we examine the literature, it is seen that there will be 5-10 times as many participants as the number of items, and the sample size should be at least 50 in the data for which factor analysis will be applied.
The sample of the second phase of the research; With G-Power, it was determined that there were 42 people in the experimental 1 group, 42 in the experimental 2 group, and 42 in the control group at 80% power, 5% error and 95% confidence interval. Data collection will take place between September 2021 and May 2022.
Location and Characteristics of the Research; The research will be carried out between December 2021 and May 2022 with primiparous pregnant women in two different Family Health Centers (ASM) affiliated to Gaziantep Provincial Health Directorate and Private Dr. Tuncay Yüce Gynecology and Obstetrics Clinic. There are 10 Family Medicine units in total in two centers, and there are baby care rooms and breastfeeding rooms where training can be provided for pregnant women in Family Health Centers.
Application of Research
Under the guidance of the literature, an item pool will be created and the content validity of the scale will be determined by taking the opinions of field experts. Care will be taken to ensure that the sample size is at least 5 times the number of items. After the approval of the ethics committee, the written consent of the primiparous pregnant women who volunteered to participate will be obtained and they will be asked to respond to the data collection tool. The data obtained will be analyzed, and the final form will be created by selecting items with high reliability according to the results obtained.
For the last form, the sample size will be calculated according to the minimum sample size formula to represent the population. The final form will be applied after obtaining written permission from the participants who volunteered to participate in the research. The obtained data will be analyzed and interpreted.
Experimental group 1
The purpose of the study will be explained to the pregnant women in the experimental group 1, and those who accepted to participate in the study and who met the criteria of the study would have to fill in the personal information form prepared by the researcher as a pre-test form, which includes socio-demographic data, and the scale developed to gain the role of motherhood. Afterwards, a 3-week training will be applied on the created web page, and the scale developed to give mothers the role of motherhood as a post-test will be applied in the first 40 days following the birth of expectant mothers.
Experimental group 2
The purpose of the study was explained to the pregnant women in the experimental group 2, and those who accepted to participate in the study and who met the criteria of the study would be asked to fill in the personal information form prepared by the researcher, containing the socio-demographic data as a pre-test form, and the scale developed to gain the role of motherhood in Primiparas. Then, a 3-week face-to-face training will be applied, and the scale developed to give mothers the role of motherhood as a post-test will be applied to mothers in the first 40 days following their birth.
Control group
The purpose of the study will be explained to the pregnant women in the control group, and those who agree to participate in the study and who meet the criteria of the study will be asked to fill in the personal information form containing their socio-demographic data as a pre-test form prepared by the researcher, and the scale developed to gain the role of motherhood in Primiparas. The pregnant women in the control group will not be trained, and the scale developed to give mothers the role of motherhood will be applied as a post-test in the first 40 days following their birth.
Educational subjects
The training consists of 3 modules.
- MODULE: Mother Module
- MODULE: Baby Module
- MODULE: Breastfeeding Module
Data Collection Tools
The data during the scale development phase will be collected using the "Draft Scale for Acquiring the Role of Motherhood" form determined in the item pool, the data collection form developed by the researcher, and the Edinburgh Postpartum Depression Scale (EDDS) and the Mother-Infant Attachment Scale (MIAS). The data in the second stage will be collected using the "Scale for Acquiring the Role of Motherhood " and the data collection form developed by the researcher.
- Being tested
- Face to face education, Web based education, No education
- Keywords
- Primipara Pregnancy, Role of Motherhood, Web-Based Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face to face educationBehavioural
Face to face education techniques on the acquisition of the mothering Role
Web based educationBehavioural
web based education techniques on the acquisition of the mothering Role
No educationBehavioural
Control group will not be educated
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | 3-week web-based education group Receives: Behavioral: Web based education |
| Experimental Group 2 | Experimental | 3-week face to face education group Receives: Behavioral: Face to face education |
| Control Group | Active comparator | Uneducated group Receives: Behavioral: No education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of education on the role of motherhood
As a result of our research, a motherhood role acquisition scale will be developed. This developed scale will be applied to pregnant women in the last trimester. By providing web-based or face-to-face training, it will be determined which training method has a positive or negative effect on gaining the role of motherhood.
Measured: 1 year and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gaining the Role of Motherhood in Primipara Pregnancy (Focus)Studies 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
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imren ARPACI, Hasan Kalyoncu University
- Investigators
- Feride Yiğit, Study director, Hasan KU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017909
- Sponsor's protocol ID
- IARPACI
- Status last verified
- Aug 2021
- First submitted
- 24 May 2021
- Last updated
- 24 Aug 2021
- 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 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Primipara Pregnancy With Two Different Methods (Face-To-Face/ Web-Based) in the Last Trimester on Their Acquisition of the Mothering Role
- ClinicalTrials.gov ID
- NCT05017909
- Acronym / sponsor ID
- IARPACI
- Keywords
- Primipara Pregnancy, Role of Motherhood, Web-Based Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 24 Aug 2021 (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.
The research consists of two stages.
First Stage: It is the development of the scale for gaining the role of motherhood in primiparas according to the scale development stages. In order to define the subject and determine the scope, the content analysis will be determined by interviewing the sample group that will not be included in the pilot application and the final scale application and the primipara people with similar characteristics. As a result, the item pool will form the basis together with the literature. An item pool related to gaining the role of motherhood will be created, the opinions of experts will be taken to evaluate the scope and appearance validity of the scale, and adjustments will be made in the item pool according to expert opinions.
In order to determine the validity and reliability of the scale, half of the participants will be tested-retested. The internal consistency reliability of the scale will be determined by the Cronbach Alpha reliability coefficient. In addition, Edinburgh Postpartum Depression Scale (EDDS) and Mother-Infant Attachment Scale (MIAS), which are similar scales, will be used in the scale development phase for the validity of the scale.
Second stage: The training consisting of 3 modules is planned. MODULE: Mother Module MODULE: Infant Module MODULE: Breastfeeding Module
At this stage of the study, pregnant women who meet the sampling criteria will be divided into groups. The determination of the groups will be according to the Randomized numbers table. Pregnant women who will enter the web-based training group (Experimental group 1), Face-to-face training group (Experimental group 2) and the control group will be determined.
The personal information form containing the socio-demographic data and the final scale developed to gain the role of motherhood in primiparas will be applied to the participants who volunteered to participate in the study.
Experimental Initiative: A web-based and face-to-face training program will be planned and implemented as separate groups for the sampled participants.
Post-Test Application of the Final Scale: The final scale, which was developed to gain the role of motherhood in primiparas, will be administered to the participants in the sample group as a post-test on the 40th day.
By analyzing the data obtained, the effectiveness of the scale and the difference between the pre-test scores of the participant group after the training program will be examined.
Detailed description
The research was planned methodologically and experimentally. A motherhood role acquisition scale will be developed as a methodological study, and web-based and face-to-face training will be given experimentally. The effect of the training given on the acquisition of the role of mother will be determined.
The research will be conducted between September 2021 and September 2022.
The Universe and Sample of the Research; the population of the research will be all primiparous pregnant women who meet the criteria for participation in the study and volunteer to participate in the study in two different Family Health Centers (FHC) affiliated to Gaziantep Provincial Health Directorate and Private Dr. Tuncay Yüce Gynecology and Obstetrics Clinic.
The sample of the first stage of the research; determined by the number of items in the scale. When we examine the literature, it is seen that there will be 5-10 times as many participants as the number of items, and the sample size should be at least 50 in the data for which factor analysis will be applied.
The sample of the second phase of the research; With G-Power, it was determined that there were 42 people in the experimental 1 group, 42 in the experimental 2 group, and 42 in the control group at 80% power, 5% error and 95% confidence interval. Data collection will take place between September 2021 and May 2022.
Location and Characteristics of the Research; The research will be carried out between December 2021 and May 2022 with primiparous pregnant women in two different Family Health Centers (ASM) affiliated to Gaziantep Provincial Health Directorate and Private Dr. Tuncay Yüce Gynecology and Obstetrics Clinic. There are 10 Family Medicine units in total in two centers, and there are baby care rooms and breastfeeding rooms where training can be provided for pregnant women in Family Health Centers.
Application of Research
Under the guidance of the literature, an item pool will be created and the content validity of the scale will be determined by taking the opinions of field experts. Care will be taken to ensure that the sample size is at least 5 times the number of items. After the approval of the ethics committee, the written consent of the primiparous pregnant women who volunteered to participate will be obtained and they will be asked to respond to the data collection tool. The data obtained will be analyzed, and the final form will be created by selecting items with high reliability according to the results obtained.
For the last form, the sample size will be calculated according to the minimum sample size formula to represent the population. The final form will be applied after obtaining written permission from the participants who volunteered to participate in the research. The obtained data will be analyzed and interpreted.
Experimental group 1
The purpose of the study will be explained to the pregnant women in the experimental group 1, and those who accepted to participate in the study and who met the criteria of the study would have to fill in the personal information form prepared by the researcher as a pre-test form, which includes socio-demographic data, and the scale developed to gain the role of motherhood. Afterwards, a 3-week training will be applied on the created web page, and the scale developed to give mothers the role of motherhood as a post-test will be applied in the first 40 days following the birth of expectant mothers.
Experimental group 2
The purpose of the study was explained to the pregnant women in the experimental group 2, and those who accepted to participate in the study and who met the criteria of the study would be asked to fill in the personal information form prepared by the researcher, containing the socio-demographic data as a pre-test form, and the scale developed to gain the role of motherhood in Primiparas. Then, a 3-week face-to-face training will be applied, and the scale developed to give mothers the role of motherhood as a post-test will be applied to mothers in the first 40 days following their birth.
Control group
The purpose of the study will be explained to the pregnant women in the control group, and those who agree to participate in the study and who meet the criteria of the study will be asked to fill in the personal information form containing their socio-demographic data as a pre-test form prepared by the researcher, and the scale developed to gain the role of motherhood in Primiparas. The pregnant women in the control group will not be trained, and the scale developed to give mothers the role of motherhood will be applied as a post-test in the first 40 days following their birth.
Educational subjects
The training consists of 3 modules.
- MODULE: Mother Module
- MODULE: Baby Module
- MODULE: Breastfeeding Module
Data Collection Tools
The data during the scale development phase will be collected using the "Draft Scale for Acquiring the Role of Motherhood" form determined in the item pool, the data collection form developed by the researcher, and the Edinburgh Postpartum Depression Scale (EDDS) and the Mother-Infant Attachment Scale (MIAS). The data in the second stage will be collected using the "Scale for Acquiring the Role of Motherhood " and the data collection form developed by the researcher.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Behavioral: Web based education3-week web-based education group |
| Experimental Group 2 | Experimental | Behavioral: Face to face education3-week face to face education group |
| Control Group | Active comparator | Behavioral: No educationUneducated group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Having a primiparous pregnancy,
- In the last trimester of pregnancy,
- At least primary school graduate,
- Able to read and understand Turkish,
- Use the internet actively and regularly access the website and receive training,
Key exclusion criteria (4 listed)
- Pregnant women who cannot access the website,
- Have any congenital defect in their baby,
- Experience mother-baby separation,
- Want to leave the research before the end of the research will not be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face to face educationFace to face education techniques on the acquisition of the mothering Role | Behavioural | Experimental Group 2 |
| Web based educationweb based education techniques on the acquisition of the mothering Role | Behavioural | Experimental Group 1 |
| No educationControl group will not be educated | Behavioural | Control Group |
Primary outcome
The effect of education on the role of motherhood
Time frame: 1 year and 6 months
As a result of our research, a motherhood role acquisition scale will be developed. This developed scale will be applied to pregnant women in the last trimester. By providing web-based or face-to-face training, it will be determined which training method has a positive or negative effect on gaining the role of motherhood.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- 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.
Feride Yiğit study director
Hasan KU
Questions about this trial
What is this clinical trial studying?
A study testing Face to face education, Web based education and No education in people with Gaining the Role of Motherhood in Primipara Pregnancy (Focus), run by Hasan Kalyoncu University.
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 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: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İmren Arpacı (+905395576147, imren2746@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of education on the role of motherhood (time frame: 1 year and 6 months). 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 24 Aug 2021.