The Effect of Postpartum Contraceptive Method Counselling on the Intention to Use Family Planning Methods

August 12, 2025 updated by: Melike Dissiz, Istanbul Saglik Bilimleri University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • University of Health Sciences, Hamidiye Institute of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Women whose partners have undergone or will undergo a vasectomy, and women who have chosen tubal ligation will not be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HBM-Based Counselling Group
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.
Behavioral: HBM-Based Postpartum Contraceptive Counselling
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.
No Intervention: Standard care group
Participants in this group will receive only routine care provided by health facilities, without any structured contraceptive counselling during the postpartum period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
in the 6th months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Saglik Bilimleri University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IstanbulSBU-HHF-MD-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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