A RANDOMİZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Menstrual Symptoms
研究概览
简要总结
Menstruation after menarche is a multidimensional experience affecting adolescents' quality of life, school attendance, and psychological adjustment. Educational and awareness-based interventions improve menstrual knowledge, attitudes, and coping behaviors; however, randomized controlled trials evaluating hybrid body awareness-based interventions are limited.
This study aims to evaluate the effect of a hybrid body awareness-based intervention on menstrual symptoms, menstrual attitudes, and self-regulation levels in post-menarche adolescent girls.
详细描述
Menstrual experience in adolescence includes physiological, cognitive, and emotional components. Negative menstrual attitudes have been associated with increased symptom perception and poorer coping strategies. Educational interventions have been shown to improve menstrual health awareness and behaviors.
Body awareness and self-regulation are psychological constructs that may influence menstrual experience and symptom management. However, there is a lack of randomized controlled trials examining hybrid (face-to-face and online) body awareness-based interventions targeting menstrual outcomes.
This randomized controlled study will evaluate the effectiveness of a 4-week hybrid body awareness-based intervention program on menstrual symptoms, menstrual attitudes, and self-regulation levels in adolescent girls within 1-2 years after menarche.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Girls aged 11-16 years
- •Within 1-2 years after menarche
- •Able to participate in training and assessments
- •Written informed consent from participant and parent/legal guardian
排除标准
- •More than 2 years since menarche
- •Diagnosed psychiatric or gynecological disorder
- •Refusal to participate
研究组 & 干预措施
Experimental Group
Participants will receive a 4-week hybrid body awareness-based intervention consisting of two face-to-face and two online sessions.
干预措施: Hybrid Body Awareness-Based Intervention (Behavioral)
Control Group
Participants will receive routine care without any structured intervention.
结局指标
主要结局
Menstrual Symptoms
时间窗: Time Frame: Baseline and 4 weeks
Measure: Menstrual Symptom Subscale;All items in the Symptom section are reverse-coded, and each subscale is scored separately; no total score is calculated. Higher subscale scores indicate a more favorable condition, reflecting reduced symptom severity. The possible score ranges are 5-25 for physical symptoms, 4-20 for emotional symptoms, and 2-10 for eating behavior. The scale is rated on a five-point Likert type (1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree). In the original reliability study, Cronbach's alpha coefficients for the subscales were 0.76, 0.76, and 0.76, and McDonald's omega was 0.87. In the present study, Cronbach's alpha coefficients were calculated as 0.85, 0.84, and 0.86, respectively.
Menstrual Attitudes
时间窗: Time Frame: Baseline and 4 weeks
Measure: Menstrual Attitude Subscale; The Attitude section consists of 19 items and four subscales: perception of menstruation, discomfort and concealment, emotions, and perceiving menstruation as an indicator of health. Items 9, 10, 11, 12, 13, 14, 15, and 16 are reverse-coded in this section. Higher subscale scores indicate more positive attitudes. The possible score ranges are 8-40 for perception of menstruation, 5-25 for discomfort and concealment, 3-15 for emotions, and 3-15 for perceiving menstruation as an indicator of health. The sections of the scale can be used separately or together, and each subscale is evaluated independently to determine the level of menstrual symptoms and attitudes. In the original reliability study, Cronbach's alpha coefficients for the subscales were 0.76, 0.69, 0.65, and 0.70, and McDonald's omega was 0.83. In the present study, Cronbach's alpha coefficients were calculated as 0.90, 0.84, 0.89, and 0.95, respectively.
次要结局
- Self-Regulation Level(Time Frame: Baseline and 4 weeks)
研究者
Hakan Avan
DR.
Kahramanmaras Sutcu Imam University