ContraceptionNCT05800548
Health Literacy of Postpartum Women and Family Planing
An observational study of Contraception and Health Attitude, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
This study was carried out as a cross-sectional-relationship searcher in order to determine the effect of evaluating the relationship between health literacy and family planning attitudes of postpartum women. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Contraception, Health Attitude, Postpartum
- What is being tested?
- survey application
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 31 Aug 2022
- 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 19 to 40 years
- Women only
- Adult
Study population: The puerperant women who met the inclusion criteria were included in the study with the method of improbable random sampling, and a total of 258 puerperant women were reached.
Who may be able to join
- Puerperant women who applied to the hospital for delivery within the research dates and gave birth in a healthy way,
- Did not have any risk for the mother and the baby,
- Had no communication barriers
Who cannot join
- Those who have any health problems of the mother and the baby,
- İlliterate,
- Communication barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Health Literacy and Family Planning Attitudes of Postpartum Women
This study was carried out as a cross-sectional-relationship searcher in order to determine the effect of evaluating the relationship between health literacy and family planning attitudes of postpartum women.
The population of the study consisted of puerperant women in the Postpartum Clinic of Osmaniye State Hospital between March 2022 and June 2022. The sample of the research is; puerperant women who applied to the hospital for delivery within the research dates and gave birth in a healthy way, did not have any risk for the mother and the baby, had no communication barriers and met the research criteria. The sample number of the study was calculated using the G*Power 3.1.9.4 program.
Read more
The puerperant women who met the inclusion criteria were included in the study with the method of improbable random sampling, and a total of 258 puerperant women were reached.
In data collection; Socio-demographic and obstetric characteristics of puerperant women, descriptive information form including questions about current birth, Postpartum Family Planning Attitude Scale The Health Literacy Scale was used. In the study, a very strong positive correlation was found between the women's total PAPTS score and SAS total score (p=0.000). In other words; As the health literacy levels of postpartum women increase, their family planning attitude levels also increase
Read the detailed description
Prior to the collection of research data, written permission was obtained from the institution where the research was conducted. On the first page of the survey, which was prepared by the researchers based on the literature review, puerperal women were informed about the study and their written consent was received. Data collection instruments were applied through face-to-face interviews to puerperal women in their own rooms in the clinic, at an appropriate time period for the infants and themselves. The application took approximately 10 to 15 minutes for each participant.
Data collection instruments The Mother Introductory Information Form (MIIF), consisting of questions about sociodemographic and obstetric characteristics, and the last delivery of puerperal mothers, the Postpartum Family Planning Attitude Scale (PFPAS), and the Health Literacy Scale (HLS) were used for data collection.
The MIIF was prepared by the researchers in accordance with the literature (Berkman et al., 2011; Yee and Simon 2014., Maricic et al., 2020). The form consists of a total of 17 questions aim to determine the sociodemographic and reproductive characteristics of the mothers.
The PFPAS, developed by Varol in 2019, includes 27 items scored on a 5-Likert type scale. 16 of the items consist of positive statements, while 11 items consist of negative statements. In order to ensure consistency in the evaluation, negative statements are reverse coded. The scale items are scored ranging from 1 to 5. Positive statements are scored as 1=Strongly disagree, 2= Disagree, 3= Neutral, 4= Agree, and 5= Strongly agree, while negative statements are scored as 5=Strongly disagree, 4=Disagree, 3= Neutral, 2= Agree, and 1= Strongly agree. The scale consists of a total of six subscales as "Perceived Risk" (Items 1, 2, 3), "Perceived Seriousness" (Items 4, 5, 6), "Perceived Benefits" (Items 7, 8, 9, 10), "Perceived Obstacles" (Items 11, 12, 13, 14, 15, 16, 17, 18), "Taking Action" (Items 19, 20, 21, 22, 23), and "Self-Efficacy" (Items 24, 25, 26, 27). The lowest score to be obtained from the scale is 27, while the highest score is 135. Higher scores indicate higher level of health belief in terms of perceived risk, perceived seriousness, perceived obstacles, perceived benefits, taking action and self-efficacy, which is also associated with a positive attitude toward FP. The Cronbach's alpha coefficient of the original scale is 0.878 (Varol, 2019). The Cronbach's alpha coefficient calculated in the current study is 0.932.
The HLS, developed by Sorensen et al., (2013), consists of 47 items and two dimensions. It was then simplified by Toçi et al., (2013), and its validity and reliability were tested. The validity and reliability study of the Turkish version, consisting of 25 items, was conducted by Aras and Temel in 2017. The scale includes four subscales as Access to Information, Understanding Information, Appraisal / Assessment, and Application / Use. The items are scored on a 5-point range as "5: No difficulty, 4: A little bit of difficulty, 3: Moderate difficulty, 2: Quite a bit of difficulty, 1: Extreme difficulty or unable to perform activity". All items include positive statements. The lowest possible score to be obtained from the scale is 25, and the highest possible score is 125. Higher scores indicate higher level of HL, while lower scores indicate inadequate, problematic and weak level of HL. The Cronbach's alpha value of the original scale is 0.92, while it ranges between 0.62 and 0.79 in the subscales (Aras \& Temel, 2017). It has been found 0.920 in the current study.
- Conditions
- Contraception, Health Attitude, Postpartum
- Being tested
- survey application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey applicationOther
In data collection; Socio-demographic and obstetric characteristics of puerperant women, descriptive information form including questions about current birth, Postpartum Family Planning Attitude Scale The Health Literacy Scale was used.
| Study group | Role | What they receive |
|---|---|---|
| postpartum women | The sample of the research is; puerperant women who applied to the hospital for delivery within the research dates and gave birth in a healthy way, did not have any risk for the mother and the baby, had no communication barriers and met the research criteria. Receives: Other: survey application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Family Planning Attitude Scale
In the study, a very strong positive correlation was found between the women's total Postpartum Family Planning Attitude Scale The Health Literacy Scale total score (p=0.000). In other words; As the health literacy levels of postpartum women increase, their family planning attitude levels also increase
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Mar 2022
- Primary completion31 May 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Collaborators
- Mersin University
- Responsible party
- Principal investigator, Derya Kaya Senol, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800548
- Sponsor's protocol ID
- DKSenol
- Status last verified
- Mar 2023
- First submitted
- 4 Oct 2022
- Last updated
- 5 Apr 2023
- 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 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Health Literacy and Family Planning Attitudes of Postpartum Women
- ClinicalTrials.gov ID
- NCT05800548
- Acronym / sponsor ID
- DKSenol
- Conditions
- Contraception, Health Attitude, Postpartum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Collaborators
- Mersin University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 5 Apr 2023 (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 was carried out as a cross-sectional-relationship searcher in order to determine the effect of evaluating the relationship between health literacy and family planning attitudes of postpartum women.
The population of the study consisted of puerperant women in the Postpartum Clinic of Osmaniye State Hospital between March 2022 and June 2022. The sample of the research is; puerperant women who applied to the hospital for delivery within the research dates and gave birth in a healthy way, did not have any risk for the mother and the baby, had no communication barriers and met the research criteria. The sample number of the study was calculated using the G*Power 3.1.9.4 program.
The puerperant women who met the inclusion criteria were included in the study with the method of improbable random sampling, and a total of 258 puerperant women were reached.
In data collection; Socio-demographic and obstetric characteristics of puerperant women, descriptive information form including questions about current birth, Postpartum Family Planning Attitude Scale The Health Literacy Scale was used. In the study, a very strong positive correlation was found between the women's total PAPTS score and SAS total score (p=0.000). In other words; As the health literacy levels of postpartum women increase, their family planning attitude levels also increase
Detailed description
Prior to the collection of research data, written permission was obtained from the institution where the research was conducted. On the first page of the survey, which was prepared by the researchers based on the literature review, puerperal women were informed about the study and their written consent was received. Data collection instruments were applied through face-to-face interviews to puerperal women in their own rooms in the clinic, at an appropriate time period for the infants and themselves. The application took approximately 10 to 15 minutes for each participant.
Data collection instruments The Mother Introductory Information Form (MIIF), consisting of questions about sociodemographic and obstetric characteristics, and the last delivery of puerperal mothers, the Postpartum Family Planning Attitude Scale (PFPAS), and the Health Literacy Scale (HLS) were used for data collection.
The MIIF was prepared by the researchers in accordance with the literature (Berkman et al., 2011; Yee and Simon 2014., Maricic et al., 2020). The form consists of a total of 17 questions aim to determine the sociodemographic and reproductive characteristics of the mothers.
The PFPAS, developed by Varol in 2019, includes 27 items scored on a 5-Likert type scale. 16 of the items consist of positive statements, while 11 items consist of negative statements. In order to ensure consistency in the evaluation, negative statements are reverse coded. The scale items are scored ranging from 1 to 5. Positive statements are scored as 1=Strongly disagree, 2= Disagree, 3= Neutral, 4= Agree, and 5= Strongly agree, while negative statements are scored as 5=Strongly disagree, 4=Disagree, 3= Neutral, 2= Agree, and 1= Strongly agree. The scale consists of a total of six subscales as "Perceived Risk" (Items 1, 2, 3), "Perceived Seriousness" (Items 4, 5, 6), "Perceived Benefits" (Items 7, 8, 9, 10), "Perceived Obstacles" (Items 11, 12, 13, 14, 15, 16, 17, 18), "Taking Action" (Items 19, 20, 21, 22, 23), and "Self-Efficacy" (Items 24, 25, 26, 27). The lowest score to be obtained from the scale is 27, while the highest score is 135. Higher scores indicate higher level of health belief in terms of perceived risk, perceived seriousness, perceived obstacles, perceived benefits, taking action and self-efficacy, which is also associated with a positive attitude toward FP. The Cronbach's alpha coefficient of the original scale is 0.878 (Varol, 2019). The Cronbach's alpha coefficient calculated in the current study is 0.932.
The HLS, developed by Sorensen et al., (2013), consists of 47 items and two dimensions. It was then simplified by Toçi et al., (2013), and its validity and reliability were tested. The validity and reliability study of the Turkish version, consisting of 25 items, was conducted by Aras and Temel in 2017. The scale includes four subscales as Access to Information, Understanding Information, Appraisal / Assessment, and Application / Use. The items are scored on a 5-point range as "5: No difficulty, 4: A little bit of difficulty, 3: Moderate difficulty, 2: Quite a bit of difficulty, 1: Extreme difficulty or unable to perform activity". All items include positive statements. The lowest possible score to be obtained from the scale is 25, and the highest possible score is 125. Higher scores indicate higher level of HL, while lower scores indicate inadequate, problematic and weak level of HL. The Cronbach's alpha value of the original scale is 0.92, while it ranges between 0.62 and 0.79 in the subscales (Aras \& Temel, 2017). It has been found 0.920 in the current study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postpartum women | – | Other: survey applicationThe sample of the research is; puerperant women who applied to the hospital for delivery within the research dates and gave birth in a healthy way, did not have any risk for the mother and the baby, had no communication barriers and met the research criteria. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The puerperant women who met the inclusion criteria were included in the study with the method of improbable random sampling, and a total of 258 puerperant women were reached.
Key inclusion criteria (3 listed)
- Puerperant women who applied to the hospital for delivery within the research dates and gave birth in a healthy way,
- Did not have any risk for the mother and the baby,
- Had no communication barriers
Key exclusion criteria (3 listed)
- Those who have any health problems of the mother and the baby,
- İlliterate,
- Communication barrier
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 |
|---|---|---|
| survey applicationIn data collection; Socio-demographic and obstetric characteristics of puerperant women, descriptive information form including questions about current birth, Postpartum Family Planning Attitude Scale The Health Literacy Scale was used. | Other | postpartum women |
Primary outcome
Postpartum Family Planning Attitude Scale
Time frame: 4 month
In the study, a very strong positive correlation was found between the women's total Postpartum Family Planning Attitude Scale The Health Literacy Scale total score (p=0.000). In other words; As the health literacy levels of postpartum women increase, their family planning attitude levels also increase
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 5 Apr 2023.
- Individual participant dataSharing planned: No
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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.
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?
An observational study of Contraception and Health Attitude, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 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 5 Apr 2023. 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?
Postpartum Family Planning Attitude Scale (time frame: 4 month). 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 5 Apr 2023.