Voluntarily Accepting to Participate in the StudyNCT06723184
Investigation of The Impact of Education Given to Grandmothers on Their Self-Confidence in Baby Care and Anxiety
A study testing The training in people with Voluntarily Accepting to Participate in the Study and At Least Primary School Graduate, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Although there are studies in the literature on the effects of antenatal education on pregnant women, there are no interventional studies on the education of grandmothers, who play an important role in the care of the newborn baby. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Voluntarily Accepting to Participate in the Study, At Least Primary School Graduate, Willing to Have Grandchildren or Having Grandchildren
- What is being tested?
- The training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Dec 2024to 10 Oct 2025
- 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
- Voluntarily accepting to participate in the study
- At least primary school graduate
- Willing to have grandchildren or having grandchildren
- Not diagnosed with any psychiatric illness
Who cannot join
- Not willing to participate in the study
- Not having at least a primary school degree
- Being diagnosed with a psychiatric disorder
- Not having grandchildren or not having grandchildren
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Health Sciences
Denizli, Kınıklı, 20160
About this study
Although there are studies in the literature on the effects of antenatal education on pregnant women, there are no interventional studies on the education of grandmothers, who play an important role in the care of the newborn baby. Therefore, the aim of this study is to examine the effects of antenatal education given to grandmothers on anxiety and self-confidence in baby care. The type of study is a randomized controlled experimental study with pre-post and control groups. The training will be given face to face to grandmothers reached through social media. At the beginning of the study, the sample size was calculated in the G-Power program by taking as reference a similar study in which the same scale (Pharis Self-Confidence Scale) was used. According to the t-test in independent groups, 95% confidence interval, 95% power and high effect size (0.98), a total of 48 people were required, 24 experimental and 24 control. Women who apply to receive training will be assigned to intervention and control groups in a block randomised manner according to their application numbers. Intention-to-treat analysis will be performed to prevent bias and losses. A total of six hours of training will be provided to the intervention group. The program content will be prepared by researchers based on literature and using childbirth preparation education philosophies.
Read the detailed description
The research is a randomized controlled experimental study with a pre-test-post-test control group. The research will be conducted with women who are grandmothers. At the beginning of the study, the sample size was calculated in the G-Power program by taking as reference a similar study in which the same scale (Pharis Self-Confidence Scale) was used. According to the t-test in independent groups, 95% confidence interval, 95% power and high effect size (0.98), a total of 48 people were required, 24 experimental and 24 control. Participants will be reached via social media. In this study, the Introductory Information Form, Pharis Self-Confidence Scale, State-Trait Anxiety Scale and Grandchild Care Knowledge Measurement Questionnaire, which reflect the sociodemographic characteristics of the participants, will be used. Women who apply with the request to receive training will be assigned to the intervention and control groups in a block randomization according to their application numbers. Intention-to-treat analysis will be performed to prevent bias and losses. As the randomization method, "block randomization" will be used to ensure that the sample size is equal in the study and control groups. Randomization will be done using the www.randomizer.org application. Data will be analyzed using the SPSS (23.0) package program. Alpha 0.05 will be accepted for significance. Mann Whitney U test and Chi-Square tests will be used to determine whether there is a difference between the groups in terms of demographic variables. Mann Whitney U test will be used to determine the difference between the Pharis Self-Esteem Scale and State-Trait Anxiety Inventory scale scores between the groups.
- Conditions
- Voluntarily Accepting to Participate in the Study, At Least Primary School Graduate, Willing to Have Grandchildren or Having Grandchildren, Not Diagnosed With Any Psychiatric Illness
- Being tested
- The training
- Keywords
- Grandmother education, Grandchild care, Sense of self-confidence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The trainingBehavioural
Behavioral: Antenatal Education Education Hours: The training will be completed in a total of three weeks and six hours, two hours each week.
Method: The training will be in a total of three weeks and six hours, two hours each week. "Informed Voluntary Consent Form" will be obtained from individuals in both groups. Grandmothers in both the control and intervention groups will be asked to fill out the "Introductory Information Form, Pharis Self-Confidence Scale, State-Trait Anxiety Scale and Knowledge Measurement Questionnaire for Grandchild Care" measurement tools. The data of the intervention group will be filled in before and after the training. The data of the control group will be filled in parallel with the intervention group. At the end of the study, the same training will be applied to the control group.
Group to receive training: Grandmothers who are expecting a grandchild and have a grandchild will be included in the training.
| Study group | Role | What they receive |
|---|---|---|
| Experimental grup | Experimental | Experimental grup Receives: Behavioral: The training |
| Control group | No intervention | No intervention grup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
This form, created in line with the literature, consists of 9 questions that include some socio-demographic characteristics of grandmothers.
Measured: It will be applied to both the experimental and control groups within 3 days before the training.
Knowledge Measurement Survey for Grandchild Care
This survey will be used to measure the knowledge level of grandmothers on topics parallel to the training content to be created and the effectiveness of the planned training. The survey consists of 25 questions.
Measured: It will be applied to both the experimental and control groups within 3 days before the training.
State and Trait Anxiety Scale
The scale was developed by Spielberger et al to determine state and trait anxiety levels separately . The Turkish adaptation of the form was made by Öner et al. The Cronbach Alpha value of the State Anxiety Scale was found to be between 0.83-0.87, and the Cronbach Alpha value of the Trait Anxiety Scale was found to be between 0.94-0.96. The inventory has two separate scales, each consisting of 20 items:
- State Anxiety Scale: Determines how the individual feels at a certain moment and under certain conditions.
- Trait Anxiety Scale: Determines how the individual generally feels, regardless of the situation and conditions they are in.
Measured: It will be applied to both the experimental and control groups within 3 days before the training.
Pharis Self-Confidence Scale
First developed by Pharis and later by Walker the internal consistency reliability was found to be between 71-91 in a study. In 2003, the validity reliability in Turkey was made by Hüsniye Çalışır. The Pharis self-confidence scale, a 13-item five-point measurement tool, measures a parent's own feelings of confidence about daily baby care. Each baby care item is rated from one (not at all) to five (completely). A high score indicates high self-confidence in baby care. The Cronbach alpha internal consistency coefficient of the scale was found to be 0.86
Measured: It will be applied to both the experimental and control groups within 3 days before the training.
Secondary outcomes (3)
Knowledge Measurement Survey for Grandchild Care
This survey will be used to measure the knowledge level of grandmothers on topics parallel to the training content to be created and the effectiveness of the planned training. The survey consists of 25 questions.
Measured: The scale will be applied to the experimental group within 3 days after the training, and to the control group at parallel times with the experimental group.
State and Trait Anxiety Scale
The scale was developed by Spielberger et al to determine state and trait anxiety levels separately . The Turkish adaptation of the form was made by Öner et al. The Cronbach Alpha value of the State Anxiety Scale was found to be between 0.83-0.87, and the Cronbach Alpha value of the Trait Anxiety Scale was found to be between 0.94-0.96. The inventory has two separate scales, each consisting of 20 items:
- State Anxiety Scale: Determines how the individual feels at a certain moment and under certain conditions.
- Trait Anxiety Scale: Determines how the individual generally feels, regardless of the situation and conditions they are in.
Measured: The scale will be applied to the experimental group within 3 days after the training, and to the control group at parallel times with the experimental group.
Pharis Self-Confidence Scale
First developed by Pharis and later by Walker the internal consistency reliability was found to be between 71-91 in a study. In 2003, the validity reliability in Turkey was made by Hüsniye Çalışır. The Pharis self-confidence scale, a 13-item five-point measurement tool, measures a parent's own feelings of confidence about daily baby care. Each baby care item is rated from one (not at all) to five (completely). A high score indicates high self-confidence in baby care.The Cronbach alpha internal consistency coefficient of the scale was found to be 0.86
Measured: The scale will be applied to the experimental group within 3 days after the training, and to the control group at parallel times with the experimental group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start13 Dec 2024
- Primary completion10 Feb 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voluntarily Accepting to Participate in the StudyStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind pre-post test randomized controlled design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra nur Kutlu, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723184
- Sponsor's protocol ID
- E-60116787-020-468763
- Status last verified
- Dec 2025
- First submitted
- 14 Oct 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Impact of Education Given to Grandmothers on Their Self-Confidence in Baby Care and Anxiety
- ClinicalTrials.gov ID
- NCT06723184
- Acronym / sponsor ID
- E-60116787-020-468763
- Conditions
- Voluntarily Accepting to Participate in the Study, At Least Primary School Graduate, Willing to Have Grandchildren or Having Grandchildren, Not Diagnosed With Any Psychiatric Illness
- Keywords
- Grandmother education, Grandchild care, Sense of self-confidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 9 Dec 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.
Although there are studies in the literature on the effects of antenatal education on pregnant women, there are no interventional studies on the education of grandmothers, who play an important role in the care of the newborn baby. Therefore, the aim of this study is to examine the effects of antenatal education given to grandmothers on anxiety and self-confidence in baby care. The type of study is a randomized controlled experimental study with pre-post and control groups. The training will be given face to face to grandmothers reached through social media. At the beginning of the study, the sample size was calculated in the G-Power program by taking as reference a similar study in which the same scale (Pharis Self-Confidence Scale) was used. According to the t-test in independent groups, 95% confidence interval, 95% power and high effect size (0.98), a total of 48 people were required, 24 experimental and 24 control. Women who apply to receive training will be assigned to intervention and control groups in a block randomised manner according to their application numbers. Intention-to-treat analysis will be performed to prevent bias and losses. A total of six hours of training will be provided to the intervention group. The program content will be prepared by researchers based on literature and using childbirth preparation education philosophies.
Detailed description
The research is a randomized controlled experimental study with a pre-test-post-test control group. The research will be conducted with women who are grandmothers. At the beginning of the study, the sample size was calculated in the G-Power program by taking as reference a similar study in which the same scale (Pharis Self-Confidence Scale) was used. According to the t-test in independent groups, 95% confidence interval, 95% power and high effect size (0.98), a total of 48 people were required, 24 experimental and 24 control. Participants will be reached via social media. In this study, the Introductory Information Form, Pharis Self-Confidence Scale, State-Trait Anxiety Scale and Grandchild Care Knowledge Measurement Questionnaire, which reflect the sociodemographic characteristics of the participants, will be used. Women who apply with the request to receive training will be assigned to the intervention and control groups in a block randomization according to their application numbers. Intention-to-treat analysis will be performed to prevent bias and losses. As the randomization method, "block randomization" will be used to ensure that the sample size is equal in the study and control groups. Randomization will be done using the www.randomizer.org application. Data will be analyzed using the SPSS (23.0) package program. Alpha 0.05 will be accepted for significance. Mann Whitney U test and Chi-Square tests will be used to determine whether there is a difference between the groups in terms of demographic variables. Mann Whitney U test will be used to determine the difference between the Pharis Self-Esteem Scale and State-Trait Anxiety Inventory scale scores between the groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blind pre-post test randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| Experimental grup | Experimental | Behavioral: The trainingExperimental grup |
| Control group | No intervention | –No intervention grup |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily accepting to participate in the study
- At least primary school graduate
- Willing to have grandchildren or having grandchildren
- Not diagnosed with any psychiatric illness
Key exclusion criteria (4 listed)
- Not willing to participate in the study
- Not having at least a primary school degree
- Being diagnosed with a psychiatric disorder
- Not having grandchildren or not having grandchildren
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 |
|---|---|---|
| The trainingBehavioral: Antenatal Education Education Hours: The training will be completed in a total of three weeks and six hours, two hours each week. Method: The training will be in a total of three weeks and six hours, two hours each week. "Informed Voluntary Consent Form" will be obtained from individuals in both groups. Grandmothers in both the control and intervention groups will be asked to fill out the "Introductory Information Form, Pharis Self-Confidence Scale, State-Trait Anxiety Scale and Knowledge Measurement Questionnaire for Grandchild Care" measurement tools. The data of the intervention group will be filled in before and after the training. The data of the control group will be filled in parallel with the intervention group. At the end of the study, the same training will be applied to the control group. Group to receive training: Grandmothers who are expecting a grandchild and have a grandchild will be included in the training. | Behavioural | Experimental grup |
Primary outcome
Introductory Information Form
Time frame: It will be applied to both the experimental and control groups within 3 days before the training.
This form, created in line with the literature, consists of 9 questions that include some socio-demographic characteristics of grandmothers.
Knowledge Measurement Survey for Grandchild Care
Time frame: It will be applied to both the experimental and control groups within 3 days before the training.
This survey will be used to measure the knowledge level of grandmothers on topics parallel to the training content to be created and the effectiveness of the planned training. The survey consists of 25 questions.
State and Trait Anxiety Scale
Time frame: It will be applied to both the experimental and control groups within 3 days before the training.
The scale was developed by Spielberger et al to determine state and trait anxiety levels separately . The Turkish adaptation of the form was made by Öner et al. The Cronbach Alpha value of the State Anxiety Scale was found to be between 0.83-0.87, and the Cronbach Alpha value of the Trait Anxiety Scale was found to be between 0.94-0.96. The inventory has two separate scales, each consisting of 20 items: 1. State Anxiety Scale: Determines how the individual feels at a certain moment and under certain conditions. 2. Trait Anxiety Scale: Determines how the individual generally feels, regardless of the situation and conditions they are in.
Pharis Self-Confidence Scale
Time frame: It will be applied to both the experimental and control groups within 3 days before the training.
First developed by Pharis and later by Walker the internal consistency reliability was found to be between 71-91 in a study. In 2003, the validity reliability in Turkey was made by Hüsniye Çalışır. The Pharis self-confidence scale, a 13-item five-point measurement tool, measures a parent's own feelings of confidence about daily baby care. Each baby care item is rated from one (not at all) to five (completely). A high score indicates high self-confidence in baby care. The Cronbach alpha internal consistency coefficient of the scale was found to be 0.86
3 secondary outcomes
Knowledge Measurement Survey for Grandchild Care
Time frame: The scale will be applied to the experimental group within 3 days after the training, and to the control group at parallel times with the experimental group.
State and Trait Anxiety Scale
Time frame: The scale will be applied to the experimental group within 3 days after the training, and to the control group at parallel times with the experimental group.
Pharis Self-Confidence Scale
Time frame: The scale will be applied to the experimental group within 3 days after the training, and to the control group at parallel times with the experimental group.
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 12 Dec 2025.
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 The training in people with Voluntarily Accepting to Participate in the Study and At Least Primary School Graduate, run by Pamukkale 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 4 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 12 Dec 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?
Introductory Information Form (time frame: It will be applied to both the experimental and control groups within 3 days before the training.). 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 12 Dec 2025.