The Effect of Sensory Awareness Education on Female Students' Body Awareness and Premenstrual Symptom Levels

July 30, 2025 updated by: YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Sağlık Bilimleri Üniversitesi
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sema AKER, Arş. Gör.
        • Sub-Investigator:
          • Aleyna BULUT, Arş. Gör.
        • Sub-Investigator:
          • İzel DEMİRHAN, Arş. Gör.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard of care (n:90)
No educational intervention will be made to the students in the control group.
Experimental: web-based sensory awareness training (n:90)

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.
Behavioral: web-based sensory awareness training

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 week
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.
6 week
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.
6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBU-AYDINKARTAL-014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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