Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-25 @ 8:38 PM
Study NCT ID:
NCT07258966
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2025-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contraception Training Using the Transtheoretical Model in Students (CT-TTM)
Sponsor:
Near East University, Turkey
Organization:
Study Overview
Official Title:
The Effect of Integrating Transtheoretical Model in Contraceptive Methods Training on University Students: A Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CT-TTM
Brief Summary:
What was the study about? This study tested whether a special training program based on the Transtheoretical Model (TTM) could help university students improve their knowledge, attitudes, and actual behavior related to contraception. The goal was to see if this method could reduce risky sexual behavior that leads to issues like sexually transmitted infections and unplanned pregnancies.
How was the study done? It was a high-quality study called a Randomized Clinical Trial (RCT).
* Participants: 68 international nursing students were split into two groups randomly.
* Intervention Group (34 students): Received the specialized TTM-based contraceptive training.
* Control Group (34 students): Did not receive the special training (they likely received standard care or nothing).
* Comparison: Researchers then compared the two groups to see if the training made a difference.
What will the study measure? The primary outcome is the change in the composite score of contraceptive competencies (knowledge, attitude, and behavior) one week after the intervention, comparing the Intervention Group to the Control Group.
What is the significance? This trial will determine the efficacy of a Transtheoretical Model-based intervention as a targeted strategy to improve contraceptive competencies and inform evidence-based health education for young adults.
How was the study done? It was a high-quality study called a Randomized Clinical Trial (RCT).
* Participants: 68 international nursing students were split into two groups randomly.
* Intervention Group (34 students): Received the specialized TTM-based contraceptive training.
* Control Group (34 students): Did not receive the special training (they likely received standard care or nothing).
* Comparison: Researchers then compared the two groups to see if the training made a difference.
What will the study measure? The primary outcome is the change in the composite score of contraceptive competencies (knowledge, attitude, and behavior) one week after the intervention, comparing the Intervention Group to the Control Group.
What is the significance? This trial will determine the efficacy of a Transtheoretical Model-based intervention as a targeted strategy to improve contraceptive competencies and inform evidence-based health education for young adults.
Detailed Description:
Detailed Description
1. Rationale and Background Unprotected sexual intercourse among young adults, particularly in the 15-49 age group, presents substantial public health challenges globally, resulting in high rates of sexually transmitted infections (STIs), unintended pregnancies, and induced abortions. Providing efficacious contraceptive knowledge and fostering informed decision-making are critical public health objectives, yet utilization is often hindered by sociocultural barriers such as religious convictions, community prejudices, and partner opposition.
This study directly addresses this need by utilizing the Transtheoretical Model (TTM) of Behavior Change to design and evaluate a structured contraceptive education program targeting international nursing students. The TTM is a widely accepted, stage-based framework positing that individuals move through distinct stages (Precontemplation, Contemplation, Preparation, Action, Maintenance, Termination) when modifying a health behavior. The core scientific premise of this trial is that an educational intervention tailored to an individual's specific stage of change will be significantly more effective in promoting positive contraceptive knowledge, attitudes, and behavior than a standard, untailored approach.
The primary objective of this randomized controlled trial is to determine the effect of a TTM-based contraceptive training program on students' knowledge, attitude, and behavior regarding contraceptive methods.
2. Study Design and Setting This is a single-center, two-arm, parallel-group, superiority, single-blind Randomized Controlled Trial (RCT). The study was conducted at the Near East University, targeting the population of international nursing students. The protocol adheres to the CONSORT 2010 guidelines for randomized trials.
Participants who scored low (0-14) on the Contraceptive Behaviour Scale (CBS) were considered eligible to ensure the intervention targeted a population with existing behavioral deficits.
3. Participants and Allocation The target population consists of international nursing students enrolled at the Near East University.
A total of N=68 eligible participants were enrolled. The sample size calculation, performed using G\*Power 3.1.9.2 software based on a medium effect size (d=0.77) from previous TTM education trials, required n=64 participants to achieve 85% power at α=0.05. An additional 5% was added for potential attrition, yielding a final N=68 (34 per arm).
Randomization: Simple randomization was performed using a web-based random number generator ('randomiser.org') by an expert external to the research team. The assignments were sealed in opaque envelopes. After baseline data collection (pre-test), the envelopes were opened by the researcher to assign participants to either the Intervention Group or the Control Group.
Blinding: This was a single-blind trial, where the participants were necessarily unmasked to their group assignment due to the nature of the active educational intervention. However, the researcher who administered the follow-up tests and the statistical analyst were blinded to the group allocations.
4. Interventions
The intervention phase consisted of two groups:
Intervention Group This arm received a comprehensive, structured educational program consisting of seven weekly 60-minute interactive sessions. The content was reviewed by five subject matter experts (3 Public Health Nursing, 1 Obstetrics and Gynaecology Nursing, 1 Sex Therapist) and systematically integrated with the TTM framework.
The educational content covered the necessity of contraception, common misconceptions, high fertility awareness, STIs and abortion, contraceptive method classification, effectiveness, advantages, disadvantages, and contraindications. The final session was a unique component dedicated to teaching students how to apply the TTM framework to their future clients. Throughout the seven sessions, the TTM was utilized to tailor educational strategies:
Pre-contemplation/Contemplation: Emphasized consciousness raising, dramatic relief, and risk awareness (Sessions 2-5).
Preparation/Action: Provided detailed counseling on method types, overcoming obstacles, and self-efficacy (Sessions 6-8).
Maintenance: Reinforced long-term adherence and consultation behaviors. One student was excluded due to non-attendance, leaving n=33 in the final intervention arm.
Control Group Participants in the control arm did not receive any specific, structured intervention from the research team during the intra-phase. They followed their normal university curriculum, which includes only elementary information regarding reproductive health integrated into various standard courses. This design controls for the passage of time and standard exposure to reproductive health topics.
5. Data Collection tools
Data were collected at two phases: Pre-Phase (Baseline), Post-Phase (One week post-intervention). The specific, validated tools used for measurement were:
Outcome Variable: Contraceptive Knowledge (Dependent), Attitude toward Contraception (Dependent), Contraceptive Behavior (Dependent) Assessment Tool: Contraceptive Knowledge Assessment Form (CKA), Contraceptive Attitude Scale (CAS), Contraceptive Behaviour Scale (CBS) Metric/Range: MCQ (0-25 score) Knowledge, 5-point Likert (32-160 score) Attitude, 5 items (0-20 score) Behaviour.
Administration Time: Baseline, Post-Intervention.
* Primary Dependent Variable: A composite of contraceptive competencies (knowledge, attitude, and behavior).
* Independent Variable: The Transtheoretical Model-based training program.
6. Statistical Analysis Data analysis was performed using SPSS (version 27). Given that the Shapiro-Wilk test indicated a non-normal distribution for the variables, non-parametric statistical methods were employed.
* Descriptive Statistics: Frequencies, percentages, medians, and interquartile ranges were calculated.
* Within-Group Analysis: The Wilcoxon signed-rank test was used to examine changes in knowledge, attitude, and behavior scores from baseline to post-intervention within each group.
* Between-Group Analysis: The Mann-Whitney U test was used to compare the difference in outcome measure scores between the Intervention and Control groups.
* Significance: All tests were two-tailed with the level of significance set at α=0.05.
* Effect Size: Effect sizes (r) were computed to quantify the magnitude of the observed differences.
The research hypotheses H01, H02, H03 all state a null effect of the TTM-based training on knowledge, attitudes, and behaviors, respectively.
7. Ethical Oversight The study protocol received ethical approval from the Institutional Review Board (IRB) of the Near East University (Approval ID: 1891/2024/127). All procedures were conducted in compliance with the Declaration of Helsinki on Human Rights. Informed consent was obtained from all participating nursing students prior to their involvement in the study.
1. Rationale and Background Unprotected sexual intercourse among young adults, particularly in the 15-49 age group, presents substantial public health challenges globally, resulting in high rates of sexually transmitted infections (STIs), unintended pregnancies, and induced abortions. Providing efficacious contraceptive knowledge and fostering informed decision-making are critical public health objectives, yet utilization is often hindered by sociocultural barriers such as religious convictions, community prejudices, and partner opposition.
This study directly addresses this need by utilizing the Transtheoretical Model (TTM) of Behavior Change to design and evaluate a structured contraceptive education program targeting international nursing students. The TTM is a widely accepted, stage-based framework positing that individuals move through distinct stages (Precontemplation, Contemplation, Preparation, Action, Maintenance, Termination) when modifying a health behavior. The core scientific premise of this trial is that an educational intervention tailored to an individual's specific stage of change will be significantly more effective in promoting positive contraceptive knowledge, attitudes, and behavior than a standard, untailored approach.
The primary objective of this randomized controlled trial is to determine the effect of a TTM-based contraceptive training program on students' knowledge, attitude, and behavior regarding contraceptive methods.
2. Study Design and Setting This is a single-center, two-arm, parallel-group, superiority, single-blind Randomized Controlled Trial (RCT). The study was conducted at the Near East University, targeting the population of international nursing students. The protocol adheres to the CONSORT 2010 guidelines for randomized trials.
Participants who scored low (0-14) on the Contraceptive Behaviour Scale (CBS) were considered eligible to ensure the intervention targeted a population with existing behavioral deficits.
3. Participants and Allocation The target population consists of international nursing students enrolled at the Near East University.
A total of N=68 eligible participants were enrolled. The sample size calculation, performed using G\*Power 3.1.9.2 software based on a medium effect size (d=0.77) from previous TTM education trials, required n=64 participants to achieve 85% power at α=0.05. An additional 5% was added for potential attrition, yielding a final N=68 (34 per arm).
Randomization: Simple randomization was performed using a web-based random number generator ('randomiser.org') by an expert external to the research team. The assignments were sealed in opaque envelopes. After baseline data collection (pre-test), the envelopes were opened by the researcher to assign participants to either the Intervention Group or the Control Group.
Blinding: This was a single-blind trial, where the participants were necessarily unmasked to their group assignment due to the nature of the active educational intervention. However, the researcher who administered the follow-up tests and the statistical analyst were blinded to the group allocations.
4. Interventions
The intervention phase consisted of two groups:
Intervention Group This arm received a comprehensive, structured educational program consisting of seven weekly 60-minute interactive sessions. The content was reviewed by five subject matter experts (3 Public Health Nursing, 1 Obstetrics and Gynaecology Nursing, 1 Sex Therapist) and systematically integrated with the TTM framework.
The educational content covered the necessity of contraception, common misconceptions, high fertility awareness, STIs and abortion, contraceptive method classification, effectiveness, advantages, disadvantages, and contraindications. The final session was a unique component dedicated to teaching students how to apply the TTM framework to their future clients. Throughout the seven sessions, the TTM was utilized to tailor educational strategies:
Pre-contemplation/Contemplation: Emphasized consciousness raising, dramatic relief, and risk awareness (Sessions 2-5).
Preparation/Action: Provided detailed counseling on method types, overcoming obstacles, and self-efficacy (Sessions 6-8).
Maintenance: Reinforced long-term adherence and consultation behaviors. One student was excluded due to non-attendance, leaving n=33 in the final intervention arm.
Control Group Participants in the control arm did not receive any specific, structured intervention from the research team during the intra-phase. They followed their normal university curriculum, which includes only elementary information regarding reproductive health integrated into various standard courses. This design controls for the passage of time and standard exposure to reproductive health topics.
5. Data Collection tools
Data were collected at two phases: Pre-Phase (Baseline), Post-Phase (One week post-intervention). The specific, validated tools used for measurement were:
Outcome Variable: Contraceptive Knowledge (Dependent), Attitude toward Contraception (Dependent), Contraceptive Behavior (Dependent) Assessment Tool: Contraceptive Knowledge Assessment Form (CKA), Contraceptive Attitude Scale (CAS), Contraceptive Behaviour Scale (CBS) Metric/Range: MCQ (0-25 score) Knowledge, 5-point Likert (32-160 score) Attitude, 5 items (0-20 score) Behaviour.
Administration Time: Baseline, Post-Intervention.
* Primary Dependent Variable: A composite of contraceptive competencies (knowledge, attitude, and behavior).
* Independent Variable: The Transtheoretical Model-based training program.
6. Statistical Analysis Data analysis was performed using SPSS (version 27). Given that the Shapiro-Wilk test indicated a non-normal distribution for the variables, non-parametric statistical methods were employed.
* Descriptive Statistics: Frequencies, percentages, medians, and interquartile ranges were calculated.
* Within-Group Analysis: The Wilcoxon signed-rank test was used to examine changes in knowledge, attitude, and behavior scores from baseline to post-intervention within each group.
* Between-Group Analysis: The Mann-Whitney U test was used to compare the difference in outcome measure scores between the Intervention and Control groups.
* Significance: All tests were two-tailed with the level of significance set at α=0.05.
* Effect Size: Effect sizes (r) were computed to quantify the magnitude of the observed differences.
The research hypotheses H01, H02, H03 all state a null effect of the TTM-based training on knowledge, attitudes, and behaviors, respectively.
7. Ethical Oversight The study protocol received ethical approval from the Institutional Review Board (IRB) of the Near East University (Approval ID: 1891/2024/127). All procedures were conducted in compliance with the Declaration of Helsinki on Human Rights. Informed consent was obtained from all participating nursing students prior to their involvement in the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: