MenstruationNCT07554053
HYBRID BODY AWARENESS INTERVENTION IN ADOLESCENT GIRLS
A study testing Hybrid Body Awareness-Based Intervention in people with Menstruation and Adolescent Health, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstruation, Adolescent Health
- What is being tested?
- Hybrid Body Awareness-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- More than 2 years since menarche
- Diagnosed psychiatric or gynecological disorder
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital
Kahramanmaraş, 46000
hakan AVAN, 05533989840, hakanavan@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Menstruation, Adolescent Health
- Being tested
- Hybrid Body Awareness-Based Intervention
- Keywords
- Adolescent, Menstruation, Body Awareness, Self-Regulation, Randomized Controlled Trial, Nursing
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Body Awareness-Based InterventionBehavioural
The intervention includes menstrual education, body awareness exercises, emotional awareness, and self-regulation strategies delivered through a structured 4-session program.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants will receive a 4-week hybrid body awareness-based intervention consisting of two face-to-face and two online sessions. Receives: Behavioral: Hybrid Body Awareness-Based Intervention |
| Control Group | No intervention | Participants will receive routine care without any structured intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Time Frame: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenstruationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Avan, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554053
- Sponsor's protocol ID
- hakanavan-0004
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMİZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07554053
- Acronym / sponsor ID
- hakanavan-0004
- Conditions
- Menstruation, Adolescent Health
- Keywords
- Adolescent, Menstruation, Body Awareness, Self-Regulation, Randomized Controlled Trial, Nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Hybrid Body Awareness-Based InterventionParticipants will receive a 4-week hybrid body awareness-based intervention consisting of two face-to-face and two online sessions. |
| Control Group | No intervention | –Participants will receive routine care without any structured intervention. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- More than 2 years since menarche
- Diagnosed psychiatric or gynecological disorder
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Body Awareness-Based InterventionThe intervention includes menstrual education, body awareness exercises, emotional awareness, and self-regulation strategies delivered through a structured 4-session program. | Behavioural | Experimental Group |
Primary outcome
Menstrual Symptoms
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.
Menstrual Attitudes
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.
1 secondary outcome
Self-Regulation Level
Time frame: Time Frame: Baseline and 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Body Awareness-Based Intervention in people with Menstruation and Adolescent Health, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hakan AVAN, Dr. (+905533989840, hakanavan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual Symptoms (time frame: Time Frame: Baseline and 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.