HYBRID BODY AWARENESS INTERVENTION IN ADOLESCENT GIRLS

A RANDOMİZED CONTROLLED 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Menstruation; Adolescent Health
• Intervention / Treatment: Behavioral: Hybrid Body Awareness-Based Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: hakan AVAN, Dr.; Phone Number: +905533989840; Email: hakanavan@gmail.com

Study Locations

• Turkey (Türkiye)
  • Kahramanmaraş, Turkey (Türkiye), 46000
    • Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital
    • Contact: hakan AVAN; Phone Number: 05533989840; Email: hakanavan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Participants will receive a 4-week hybrid body awareness-based intervention consisting of two face-to-face and two online sessions.	Behavioral: Hybrid 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.
No Intervention: Control Group; Participants will receive routine care without any structured intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Baseline and 4 weeks
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: Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Adolescent; Randomized Controlled Trial; Nursing; Self-Regulation; Menstruation; Body Awareness
• Additional Relevant MeSH Terms: Behavior; Social Behavior; Self-Control
• Other Study ID Numbers: hakanavan-0004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be publicly shared due to the need to protect participant confidentiality and privacy. Data may be made available from the corresponding author upon reasonable request and with appropriate ethical approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No