HYBRID BODY AWARENESS INTERVENTION IN ADOLESCENT GIRLS

NCT07554053 | Not Yet Recruiting DMC

• 1 other identifier: hakanavan-0004
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstruation; Adolescent Health

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Self-Regulation Level

  Time Frame: Baseline and 4 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants will receive routine care without any structured intervention.

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 11 Years - 16 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital

Kahramanmaraş, 46000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Central Study Contacts

hakan AVAN, Dr.

CONTACT

+905533989840; hakanavan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)