for GirlsNCT07097181
The Effect of Sensory Awareness Education on Female Students' Body Awareness and Premenstrual Symptom Levels
A study testing web-based sensory awareness training in people with for Girls and Sensory Awareness Training, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This research investigates the effects of web-based sensory awareness training on female students' body movements. In order to examine its effect on awareness and premenstrual symptom levels. planned. H0a = Body awareness levels of female students who receive and do not receive sensory awareness training. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- for Girls, Sensory Awareness Training, Body Awareness
- What is being tested?
- web-based sensory awareness training
- 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
- 31 Aug 2025to 31 Dec 2025
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in research.
- University of Health Sciences, Hamidiye Faculty of Health Sciences, Department of Midwifery Being an active student in the first grade.
- University of Health Sciences, Hamidiye Faculty of Health Sciences, Physiotherapy and Being an active female student in the first year of the Department of Rehabilitation.
- Having internet access.
- Having a smart mobile phone.
Who cannot join
- University of Health Sciences, Hamidiye Faculty of Health Sciences, Department of Midwifery Being a passive student in the first grade.
- University of Health Sciences, Hamidiye Faculty of Health Sciences, Physiotherapy and Being a passive female student in the first year of the Rehabilitation Department.
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
Sağlık Bilimleri Üniversitesi
Istanbul
Yasemin AYDIN KARTAL, Doç. Dr., yasemin.aydin@sbu.edu.tr
Büşra HIZLIOL, Arş. Gör., busra.hizliol@sbu.edu.tr
About this study
This research investigates the effects of web-based sensory awareness training on female students' body movements.
In order to examine its effect on awareness and premenstrual symptom levels. planned. H0a = Body awareness levels of female students who receive and do not receive sensory awareness training. There is no difference between.
Read more
H1a = Body awareness levels of female students who receive and do not receive sensory awareness training. There is a difference between .
H0b = Premenstrual symptoms of female students who received and did not receive sensory awareness training. There is no difference between the levels.
H1b = Premenstrual symptoms of female students who receive and do not receive sensory awareness training. There is a difference between the levels.
Participants will be given sensory awareness training for 4 weeks and female students will be given "Premenstrual Syndrome Scale" and "Very" before the training and 4 weeks after the first training.Dimensional Body Awareness Assessment-II Scale" will be applied
Read the detailed description
The study will be conducted online via https://teams.microsoft.com/v2/. Female first-year students from the Midwifery Department and the Physiotherapy and Rehabilitation Department of SBÜ Hamidiye Faculty of Health Sciences who volunteer to participate will be assigned to the intervention group (n=90) and control group (n=90) using random numbers generated via https://www.randomizer.org/ by the researchers. All participants will complete an introductory information form.
Female students in the intervention group will receive sensory awareness training for four weeks. The training content will include presentations on the Sensory System, Proprioception and Kinesthesia, and Interoception. Following the presentations, a protocol focusing on body awareness will be implemented, including graded sensory discrimination, graded motor imagery (GMI), interoception awareness training, interoceptive awareness exercises, and home exercise programs. Each training session will be planned to last 60 minutes.
A pre-training briefing session will be held with the female students assigned to the intervention group who volunteer to participate. The "Premenstrual Syndrome Scale" and the "Multidimensional Assessment of Interoceptive Awareness-II Scale" will be administered to the students before the training and four weeks after the first session. Each training session will be conducted once a week and will be limited to 60 minutes. The study forms will be administered to participants in person.
- Being tested
- web-based sensory awareness training
- Keywords
- sensory awareness, education, student, premenstrual syndrome
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based sensory awareness trainingBehavioural
The girl in the intervention group of the study 4 weeks to inform students, raise awareness and provide sensory education. Sensory awareness training will be provided throughout. Presentations to inform during training will be done, then Graded Sensory Discrimination, Graded Motor Imagery (DMI) and a home exercise program, as well as a body awareness training program.
protocol will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care (n:90) | No intervention | No educational intervention will be made to the students in the control group. |
| web-based sensory awareness training (n:90) | Experimental | Female students in the intervention group will receive sensory awareness training for four weeks. The training content will include presentations on the Sensory System, Proprioception and Kinesthesia, and Interoception. Following these presentations, a protocol focusing on body awareness will be implemented. This protocol will consist of graded sensory discrimination, graded motor imagery (GMI), interoception awareness training, interoceptive awareness exercises, and a home exercise program. Each training session will be planned to last 60 minutes.
A pre-training briefing session will be held with female students who volunteer to participate and are assigned to the intervention group. Receives: Behavioral: web-based sensory awareness training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
In this form created by researchers based on the literature, It includes questions about the participants' age, high school they graduated from, menstrual period and symptoms.
is taking.
Measured: 6 week
Premenstrual Syndrome Scale (PMSS)
The scale was developed by Gençdoğan in 2006. It consists of 44 items and is designed in a five-point Likert format. The scoring of the scale is as follows: "Never" is scored as 1 point, "Rarely" as 2 points, "Sometimes" as 3 points, "Often" as 4 points, and "Always" as 5 points. The scale includes nine subdimensions:Fatigue ,Depressive Affect,Depressive Thoughts,Anxiety ,Irritability ,Appetite Changes ,Pain ,Sleep Changes ,Bloating.The PMS Scale (PMSÖ) score is obtained by summing the scores of these subdimensions. The scale is administered by asking the individual to respond based on their experience during the week before their menstruation. The total score ranges from a minimum of 44 to a maximum of 220. A higher score indicates more severe premenstrual symptoms.
Measured: 6 week
Multidimensional Body Awareness Assessment-II Scale
Body Awareness has multiple developed by Mehling, Acree, Stewart, Silas and Jones to measure the dimensions of The Turkish adaptation of the scale was made by Mungurlar and Kahya. Scale, 37 It is a self-report scale consisting of one item and eight factors. These factors; "Noticing", "Attention "Not Distracting", "Not Worrying", "Regulating Attention", "Emotional Awareness", "Self-Regulation", "Listening to the Body" and "Trusting". Evaluation of the scale is 1-5 points and is made by averaging the scoring factors separately. of scale Validity reliability Cronbach's alpha coefficient was determined as 0.88. As the score obtained from the scale increases, it means that people have more positive body awareness.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start31 Aug 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for for GirlsStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sensory awareness training was given to the female students in the intervention group of the research for 4 weeks. training will be given. Training contents, Sensory System Training Presentation, Proprioception and Kinesthesia Sense Training Presentation, Interoception Sense Training Presentation will be held later. Graded Sensory Discrimination, Graded Motor Imagery (DMI), interoception consisting of awareness training, interoceptive awareness exercises and home exercises program. A protocol for training and body awareness training will be implemented.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097181
- Sponsor's protocol ID
- SBU-AYDINKARTAL-014
- Status last verified
- Jul 2025
- First submitted
- 8 Dec 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sensory Awareness Education on Female Students' Body Awareness and Premenstrual Symptom Levels
- ClinicalTrials.gov ID
- NCT07097181
- Acronym / sponsor ID
- SBU-AYDINKARTAL-014
- Keywords
- sensory awareness, education, student, premenstrual syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Jul 2025 (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.
This research investigates the effects of web-based sensory awareness training on female students' body movements.
In order to examine its effect on awareness and premenstrual symptom levels. planned. H0a = Body awareness levels of female students who receive and do not receive sensory awareness training. There is no difference between.
H1a = Body awareness levels of female students who receive and do not receive sensory awareness training. There is a difference between .
H0b = Premenstrual symptoms of female students who received and did not receive sensory awareness training. There is no difference between the levels.
H1b = Premenstrual symptoms of female students who receive and do not receive sensory awareness training. There is a difference between the levels.
Participants will be given sensory awareness training for 4 weeks and female students will be given "Premenstrual Syndrome Scale" and "Very" before the training and 4 weeks after the first training.Dimensional Body Awareness Assessment-II Scale" will be applied
Detailed description
The study will be conducted online via https://teams.microsoft.com/v2/. Female first-year students from the Midwifery Department and the Physiotherapy and Rehabilitation Department of SBÜ Hamidiye Faculty of Health Sciences who volunteer to participate will be assigned to the intervention group (n=90) and control group (n=90) using random numbers generated via https://www.randomizer.org/ by the researchers. All participants will complete an introductory information form.
Female students in the intervention group will receive sensory awareness training for four weeks. The training content will include presentations on the Sensory System, Proprioception and Kinesthesia, and Interoception. Following the presentations, a protocol focusing on body awareness will be implemented, including graded sensory discrimination, graded motor imagery (GMI), interoception awareness training, interoceptive awareness exercises, and home exercise programs. Each training session will be planned to last 60 minutes.
A pre-training briefing session will be held with the female students assigned to the intervention group who volunteer to participate. The "Premenstrual Syndrome Scale" and the "Multidimensional Assessment of Interoceptive Awareness-II Scale" will be administered to the students before the training and four weeks after the first session. Each training session will be conducted once a week and will be limited to 60 minutes. The study forms will be administered to participants in person.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Sensory awareness training was given to the female students in the intervention group of the research for 4 weeks. training will be given. Training contents, Sensory System Training Presentation, Proprioception and Kinesthesia Sense Training Presentation, Interoception Sense Training Presentation will be held later. Graded Sensory Discrimination, Graded Motor Imagery (DMI), interoception consisting of awareness training, interoceptive awareness exercises and home exercises program. A protocol for training and body awareness training will be implemented.
| Arm | Type | Receives |
|---|---|---|
| Standard of care (n:90) | No intervention | –No educational intervention will be made to the students in the control group. |
| web-based sensory awareness training (n:90) | Experimental | Behavioral: web-based sensory awareness trainingFemale students in the intervention group will receive sensory awareness training for four weeks. The training content will include presentations on the Sensory System, Proprioception and Kinesthesia, and Interoception. Following these presentations, a protocol focusing on body awareness will be implemented. This protocol will consist of graded sensory discrimination, graded motor imagery (GMI), interoception awareness training, interoceptive awareness exercises, and a home exercise program. Each training session will be planned to last 60 minutes. A pre-training briefing session will be held with female students who volunteer to participate and are assigned to the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteering to participate in research.
- University of Health Sciences, Hamidiye Faculty of Health Sciences, Department of Midwifery Being an active student in the first grade.
- University of Health Sciences, Hamidiye Faculty of Health Sciences, Physiotherapy and Being an active female student in the first year of the Department of Rehabilitation.
- Having internet access.
- Having a smart mobile phone.
Key exclusion criteria (2 listed)
- University of Health Sciences, Hamidiye Faculty of Health Sciences, Department of Midwifery Being a passive student in the first grade.
- University of Health Sciences, Hamidiye Faculty of Health Sciences, Physiotherapy and Being a passive female student in the first year of the Rehabilitation Department.
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 |
|---|---|---|
| web-based sensory awareness trainingThe girl in the intervention group of the study 4 weeks to inform students, raise awareness and provide sensory education. Sensory awareness training will be provided throughout. Presentations to inform during training will be done, then Graded Sensory Discrimination, Graded Motor Imagery (DMI) and a home exercise program, as well as a body awareness training program. protocol will be applied. | Behavioural | web-based sensory awareness training (n:90) |
Primary outcome
Introductory Information Form
Time frame: 6 week
In this form created by researchers based on the literature, It includes questions about the participants' age, high school they graduated from, menstrual period and symptoms. is taking.
Premenstrual Syndrome Scale (PMSS)
Time frame: 6 week
The scale was developed by Gençdoğan in 2006. It consists of 44 items and is designed in a five-point Likert format. The scoring of the scale is as follows: "Never" is scored as 1 point, "Rarely" as 2 points, "Sometimes" as 3 points, "Often" as 4 points, and "Always" as 5 points. The scale includes nine subdimensions:Fatigue ,Depressive Affect,Depressive Thoughts,Anxiety ,Irritability ,Appetite Changes ,Pain ,Sleep Changes ,Bloating.The PMS Scale (PMSÖ) score is obtained by summing the scores of these subdimensions. The scale is administered by asking the individual to respond based on their experience during the week before their menstruation. The total score ranges from a minimum of 44 to a maximum of 220. A higher score indicates more severe premenstrual symptoms.
Multidimensional Body Awareness Assessment-II Scale
Time frame: 6 week
Body Awareness has multiple developed by Mehling, Acree, Stewart, Silas and Jones to measure the dimensions of The Turkish adaptation of the scale was made by Mungurlar and Kahya. Scale, 37 It is a self-report scale consisting of one item and eight factors. These factors; "Noticing", "Attention "Not Distracting", "Not Worrying", "Regulating Attention", "Emotional Awareness", "Self-Regulation", "Listening to the Body" and "Trusting". Evaluation of the scale is 1-5 points and is made by averaging the scoring factors separately. of scale Validity reliability Cronbach's alpha coefficient was determined as 0.88. As the score obtained from the scale increases, it means that people have more positive body awareness.
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 31 Jul 2025.
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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 web-based sensory awareness training in people with for Girls and Sensory Awareness Training, run by Saglik Bilimleri Universitesi 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 5 inclusion and 2 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 31 Jul 2025. 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 Yasemin AYDIN KARTAL, Doç. Dr. (0543 287 00 29, yasemin.aydin@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: 6 week). The study lists 3 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 31 Jul 2025.