Health TrialsbyHealthPanel

HYBRID BODY AWARENESS INTERVENTION IN ADOLESCENT GIRLS

ConditionsMenstruationAdolescent Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age11-16
SponsorKahramanmaras Sutcu Imam University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

More than 2 years since menarche

Diagnosed psychiatric or gynecological disorder

Refusal to participate

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hybrid Body Awareness-Based Intervention

    Behavioral

    The intervention includes menstrual education, body awareness exercises, emotional awareness, and self-regulation strategies delivered through a structured 4-session program.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Menstrual Symptoms

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
2

Menstrual Attitudes

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

Secondary outcomes

1

Self-Regulation Level

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.

Time frame
Time Frame: Baseline and 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kahramanmaras Sutcu Imam University

Lead sponsor

Source ClinicalTrials.gov

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