The Effect of Integrating Transtheoretical Model in Contraceptive Methods Training on University Students: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Contraceptive Behavior Scale (CBS)
研究概览
简要总结
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.
详细描述
Detailed Description
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
The only party that could potentially have been masked was the Outcomes Assessor; however, the study protocol dictated no party was formally blinded to simplify data collection and management
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers within the international nursing student group
- •Sexually active
- •Individuals with low scores (0-14 score) on the 'Contraceptive Behaviour Scale'.
排除标准
- •Those who do not want to participate in the study
- •Those under the age of 18
- •Those who are planning a pregnancy
结局指标
主要结局
Contraceptive Behavior Scale (CBS)
时间窗: Post-Intervention (7 Weeks)
Change in the Contraceptive Behavior Scale (CBS) total score from Baseline (Pre-test) to Post-Intervention (1 week after the 7-session training). The CBS is a 5-item scale with a score range of 0 (minimum behavior) to 20 (maximum behavior). This measure will assess the effect of the TTM-based training on participants' contraceptive behavior.
次要结局
- Contraceptive Attitude Scale (CAS) Score(Post-Intervention (7weeks))
- Contraceptive Knowledge Assessment (CKA) Score Change in Contraceptive Knowledge Score 2. For Attitude: Change in Attitude Score toward Contraceptive Use(Post-Intervention (7weeks))
- Contraceptive Attitude Scale (CAS) Score(Post-Intervention (7weeks))
- Contraceptive Knowledge Assessment (CKA) Score Change in Contraceptive Knowledge Score 2. For Attitude: Change in Attitude Score toward Contraceptive Use(Post-Intervention (7weeks))
研究者
Jonathan Nicıza
Principal Investigator
Near East University, Turkey