Skip to content

HYBRID BODY AWARENESS INTERVENTION IN ADOLESCENT GIRLS

A RANDOMİZED CONTROLLED TRIAL

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07554053
Enrollment
180
Registered
2026-04-28
Start date
2026-05-15
Completion date
2026-09-15
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Health, Menstruation

Keywords

Adolescent, Menstruation, Body Awareness, Self-Regulation, Randomized Controlled Trial, Nursing

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALHybrid Body Awareness-Based Intervention

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

Sponsors

Kahramanmaras Sutcu Imam University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
11 Years to 16 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* More than 2 years since menarche * Diagnosed psychiatric or gynecological disorder * Refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
Menstrual SymptomsTime Frame: Baseline and 4 weeksMeasure: 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 AttitudesTime Frame: Baseline and 4 weeksMeasure: 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.

Secondary

MeasureTime frameDescription
Self-Regulation LevelTime Frame: Baseline and 4 weeksMeasure: 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.

Countries

Turkey (Türkiye)

Contacts

CONTACThakan AVAN, Dr.
hakanavan@gmail.com+905533989840

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026