Postpartum Contraceptive CounselingNCT07119554
The Effect of Postpartum Contraceptive Method Counselling on the Intention to Use Family Planning Methods
A study testing HBM-Based Postpartum Contraceptive Counselling in people with Postpartum Contraceptive Counseling, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
With the acceleration of developments in health technology, changes have occurred in professional knowledge and practices, as well as in patient needs and expectations. These changes have also influenced the way nursing care is delivered, leading to a shift from traditionally applied training methods to more modern… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Contraceptive Counseling
- What is being tested?
- HBM-Based Postpartum Contraceptive Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who volunteered to participate in the study,
- were 18 years of age or older,
- were primiparous,
- spoke Turkish,
- owned a smartphone,
- had no chronic illness or diagnosed mental or psychiatric illness, were included in the study.
Who cannot join
- Women whose partners have undergone or will undergo a vasectomy, and women who have chosen tubal ligation will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Hamidiye Institute of Health Sciences
Istanbul
About this study
Official title: The Effect of Postpartum Contraceptive Method Counseling Based on Health Belief Model on Family Planning Attitudes and Intention to Use Contraceptives
With the acceleration of developments in health technology, changes have occurred in professional knowledge and practices, as well as in patient needs and expectations. These changes have also influenced the way nursing care is delivered, leading to a shift from traditionally applied training methods to more modern and technology-based education tools. These include telephone counseling, online and web-based counseling, and the use of models.
In recent years, the use of motivational interviewing techniques in providing counseling services has become increasingly common in the field of nursing and is considered an effective communication method. In light of this information, the aim of this study is to evaluate the effect of postpartum contraceptive counseling based on the Health Belief Model using motivational interviewing techniques, along with spousal participation, on women's attitudes toward family planning and their intention to use contraceptives.
Read the detailed description
The aim of this study was to evaluate the effect of postpartum contraception counselling based on the health belief model on family planning attitudes and contraceptive method use intentions. The study was designed as a randomised controlled trial. The study population will consist of women who visited the postpartum ward at Zeynep Kâmil Women's and Children's Diseases Training and Research Hospital in Istanbul between March 2025 and November 2025. In the study, the sample size was calculated using the 'G. Power-3.1.9.2' programme at a 95% confidence level prior to the data collection phase. The study will evaluate the effect of motivational interviews based on the Health Belief Model on family planning attitudes and contraceptive use intentions. Accordingly, the scores from the 'Family Planning Attitude Scale' (difference between the intervention and control groups) used in Tavukçu's (2024) study were referenced for calculation (63). Accordingly, it was estimated that the minimum sample size required for 80% power at a significance level of 0.05 and an effect size of 0.794 would be 26 participants per group (total 52). Considering that a 20% loss may occur during the research process, the sample is planned to consist of 62 participants (intervention group = 31, control group = 31). Data collection will begin after the necessary institutional permission, ethics committee permission, and scale usage permissions have been obtained. A simple randomisation method will be used to randomly select individuals from the population and assign them to the intervention and control groups without bias. Volunteers who meet the inclusion criteria will be informed about the study and their consent will be obtained before randomisation. Using the computer-assisted https://www.random.org/integers/ programme, 31 participants will be assigned to the intervention group and 31 participants to the control group using a simple randomisation method.
- Conditions
- Postpartum Contraceptive Counseling
- Being tested
- HBM-Based Postpartum Contraceptive Counselling
- Keywords
- Postpartum, Regulation of fertility, Contraception, Motivational interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBM-Based Postpartum Contraceptive CounsellingBehavioural
This intervention involves providing a structured, individual contraceptive counseling session based on the Health Belief Model (HBM) to women in the postpartum period.The session is delivered face-to-face, lasts approximately 30 to 45 minutes, and is structured around the core components of the HBM: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy, and cues to action. The aim of the intervention is to improve attitudes toward family planning and increase the intention to use contraceptive methods.
| Study group | Role | What they receive |
|---|---|---|
| HBM-Based Counselling Group | Experimental | Participants in this group will receive individual contraceptive counselling based on the Health Belief Model (HBM) from the first month after birth until the sixth month. Receives: Behavioral: HBM-Based Postpartum Contraceptive Counselling |
| Standard care group | No intervention | Participants in this group will receive only routine care provided by health facilities, without any structured contraceptive counselling during the postpartum period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in attitudes toward family planning and contraceptive method use intention scale scores at 6 months
Postpartum contraceptive method counseling provided through motivational interviewing based on the health belief model
Measured: in the 6th months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Jul 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Contraceptive CounselingStudies 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
- Model description
- A randomised controlled trial using motivational interviewing in two groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Dissiz, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119554
- Sponsor's protocol ID
- IstanbulSBU-HHF-MD-01
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postpartum Contraceptive Method Counseling Based on Health Belief Model on Family Planning Attitudes and Intention to Use Contraceptives
- ClinicalTrials.gov ID
- NCT07119554
- Acronym / sponsor ID
- IstanbulSBU-HHF-MD-01
- Conditions
- Postpartum Contraceptive Counseling
- Keywords
- Postpartum, Regulation of fertility, Contraception, Motivational interviewing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 13 Aug 2025 (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.
With the acceleration of developments in health technology, changes have occurred in professional knowledge and practices, as well as in patient needs and expectations. These changes have also influenced the way nursing care is delivered, leading to a shift from traditionally applied training methods to more modern and technology-based education tools. These include telephone counseling, online and web-based counseling, and the use of models.
In recent years, the use of motivational interviewing techniques in providing counseling services has become increasingly common in the field of nursing and is considered an effective communication method. In light of this information, the aim of this study is to evaluate the effect of postpartum contraceptive counseling based on the Health Belief Model using motivational interviewing techniques, along with spousal participation, on women's attitudes toward family planning and their intention to use contraceptives.
Detailed description
The aim of this study was to evaluate the effect of postpartum contraception counselling based on the health belief model on family planning attitudes and contraceptive method use intentions. The study was designed as a randomised controlled trial. The study population will consist of women who visited the postpartum ward at Zeynep Kâmil Women's and Children's Diseases Training and Research Hospital in Istanbul between March 2025 and November 2025. In the study, the sample size was calculated using the 'G. Power-3.1.9.2' programme at a 95% confidence level prior to the data collection phase. The study will evaluate the effect of motivational interviews based on the Health Belief Model on family planning attitudes and contraceptive use intentions. Accordingly, the scores from the 'Family Planning Attitude Scale' (difference between the intervention and control groups) used in Tavukçu's (2024) study were referenced for calculation (63). Accordingly, it was estimated that the minimum sample size required for 80% power at a significance level of 0.05 and an effect size of 0.794 would be 26 participants per group (total 52). Considering that a 20% loss may occur during the research process, the sample is planned to consist of 62 participants (intervention group = 31, control group = 31). Data collection will begin after the necessary institutional permission, ethics committee permission, and scale usage permissions have been obtained. A simple randomisation method will be used to randomly select individuals from the population and assign them to the intervention and control groups without bias. Volunteers who meet the inclusion criteria will be informed about the study and their consent will be obtained before randomisation. Using the computer-assisted https://www.random.org/integers/ programme, 31 participants will be assigned to the intervention group and 31 participants to the control group using a simple randomisation method.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomised controlled trial using motivational interviewing in two groups
| Arm | Type | Receives |
|---|---|---|
| HBM-Based Counselling Group | Experimental | Behavioral: HBM-Based Postpartum Contraceptive CounsellingParticipants in this group will receive individual contraceptive counselling based on the Health Belief Model (HBM) from the first month after birth until the sixth month. |
| Standard care group | No intervention | –Participants in this group will receive only routine care provided by health facilities, without any structured contraceptive counselling during the postpartum period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women who volunteered to participate in the study,
- were 18 years of age or older,
- were primiparous,
- spoke Turkish,
- owned a smartphone,
Key exclusion criteria (1 listed)
- Women whose partners have undergone or will undergo a vasectomy, and women who have chosen tubal ligation 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 |
|---|---|---|
| HBM-Based Postpartum Contraceptive CounsellingThis intervention involves providing a structured, individual contraceptive counseling session based on the Health Belief Model (HBM) to women in the postpartum period.The session is delivered face-to-face, lasts approximately 30 to 45 minutes, and is structured around the core components of the HBM: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy, and cues to action. The aim of the intervention is to improve attitudes toward family planning and increase the intention to use contraceptive methods. | Behavioural | HBM-Based Counselling Group |
Primary outcome
Change from baseline in attitudes toward family planning and contraceptive method use intention scale scores at 6 months
Time frame: in the 6th months after birth
Postpartum contraceptive method counseling provided through motivational interviewing based on the health belief model
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Postpartum Contraceptive Counseling
Recruiting
Structured Contraceptive Counseling During Pregnancy
Contraception, Intrauterine Device
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 HBM-Based Postpartum Contraceptive Counselling in people with Postpartum Contraceptive Counseling, run by Istanbul Saglik Bilimleri 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 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in attitudes toward family planning and contraceptive method use intention scale scores at 6 months (time frame: in the 6th months after birth). 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 13 Aug 2025.