Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital
Kahramanmaraş, 46000, Turkey (Türkiye)
NCT Number: NCT07554053
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.
Trial opening soon.
Get Notified11 year–16 year
Female
Interventional
Not applicable
Kahramanmaraş, 46000, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention includes menstrual education, body awareness exercises, emotional awareness, and self-regulation strategies delivered through a structured 4-session program.
Time frame: 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.
Time frame: 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.
Time frame: Time Frame: Baseline and 4 weeks
Measure: Adolescent Self-Regulation Scale; The Self-Regulation Skills Scale (minimum-maximum score: 11-55; higher scores indicate better self-regulation) was developed to assess adolescents' self-regulation skills. The scale consists of 11 items and has a unidimensional structure. Items are rated on a five-point Likert scale (1 = strongly disagree to 5 = strongly agree). In the original reliability study, Cronbach's alpha was 0.90, McDonald's omega was 0.89, and the Composite Reliability (CR) was 0.89. The test-retest correlation was 0.78, indicating temporal stability. In the present study, Cronbach's alpha was calculated as 0.92.
Contact information is provided by the study sponsor or research team.
Kahramanmaras Sutcu Imam University
Other
A RANDOMİZED CONTROLLED TRIAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06888245
Animation, Education
View Trial DetailsNCT05412771
Menstruation
Paris, France
View Trial DetailsNCT07052500
Dysmenorrhea, Menstrual Cramps
Loma Linda, California, United States
View Trial DetailsNCT07653620
Dehydration, Hydration
Bradenton, Florida, United States
View Trial Details