DysmenorrheaNCT07097285
The Effect of Sensory Awareness Training Given to Women of Reproductive Age on Dysmenorrhea and Kinesiophobia
A study testing sensory awareness training in people with Dysmenorrhea and Kinesiophobia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This research investigates the use of web-based sensory awareness training given to women of reproductive age. It was planned to examine the effect of dysmenorrhea level and kinzeophobia status.H0a = Body weight of women of reproductive age who received and did not receive sensory awareness training. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Dysmenorrhea, Kinesiophobia
- What is being tested?
- sensory awareness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 Jun 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteering to participate in research
- Having a complaint of dysmonea
- Being of childbearing age
- Being over 19 years old
- Having internet access
- Having a smart mobile phone
Who cannot join
- Be pregnant
- Having any disease that affects the menstrual period
- Using oral contraceptives
- Using intrauterine device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This research investigates the use of web-based sensory awareness training given to women of reproductive age. It was planned to examine the effect of dysmenorrhea level and kinzeophobia status.H0a = Body weight of women of reproductive age who received and did not receive sensory awareness training. There is no difference between awareness levels.
H1a = Body size of women of reproductive age who receive and do not receive sensory awareness training. There is a difference between awareness levels.
Read more
H0b = Dysmenorrhea of women of reproductive age who received or did not receive sensory awareness training. There is no difference between the levels.
H1b = Dysmenorrhea among women of reproductive age who received and did not receive sensory awareness training. There is a difference between the levels.
H0c = Kinesiophobia in women of childbearing age who received or did not receive sensory awareness training. There is no difference between the situations.
H1c = Kinesiophobia in women of reproductive age who receive and do not receive sensory awareness training. There is a difference between situations Sensory awareness training was given to women in the intervention group of the study for 4 weeks. will be given. Training contents, Sensory System Training Presentation, Proprioception and Kinesthesia Sensory Training Presentation, Interoception Sense Training Presentation will be given, then Graded Sensory Discrimination, Graded Motor Imagery (DMI), interoception awareness training, body training with training consisting of interoceptive awareness exercises and home exercise programs. A protocol for awareness training will be implemented.
Read the detailed description
Sensory awareness training was given to women in the intervention group of the study for 4 weeks will be given. Training contents, Sensory System Training Presentation, Proprioception and Kinesthesia Sensory Training Presentation, Interoception Sense Training Presentation will be given, then Graded Sensory Discrimination, Graded Motor Imagery (DMI), interoception awareness training, body training with training consisting of interoceptive awareness exercises and home exercise programs.
A protocol for awareness training will be implemented. Each training is 60 minutes long will be planned. Women who volunteered to participate in the study and were assigned to the intervention group An informational meeting will be held before the training. 4 weeks from pre-training and first training "Tampa Kinesiophobia Scale (TKÖ)" "Dysmenorrhea Affectedness Scale" and "Very Dimensional Body Awareness Assessment-II Scale" will be applied. be once a week Each training period is limited to 60 minutes. Research forms were given to participants face to face. will be implemented.
- Conditions
- Dysmenorrhea, Kinesiophobia
- Being tested
- sensory awareness training
- Keywords
- Sensory Awareness, Dysmenorrhea, Kinesiophobia, Reproductive, Women
- Medical subject headings
- Dysmenorrhea, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory awareness trainingBehavioural
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. Graded Sensory Discrimination protocol, localization training It includes level 1, localization training level 2 and graphesthesia training. Graded Engine Visualization (DMI) protocol includes right/left discrimination training and visual imagery training.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care (n:40) | No intervention | No intervention will be made to the control group. |
| sensory awareness training (n:40) | Experimental | Sensory awareness training was given to women in the intervention group of the study for 4 weeks. will be given. Each training is 60 minutes long will be planned. 4 weeks from pre-training and first training "Tampa Kinesiophobia Scale (TKÖ)" "Dysmenorrhea Affectedness Scale" and "Very Dimensional Body Awareness Assessment-II Scale" will be applied. be once a week Each training period is limited to 60 minutes. Research forms were given to participants face to face. will be implemented. Receives: Behavioral: 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, There are questions about the participants' age, the high school they graduated from, dysmenorrhea and kinesiophobia is taking.
Measured: Baseline
Tampa Kinesiophobia Scale
Tampa Kinesiophobia Scale (TCS) Miller, Kori and Todd It is a scale developed by in 1991. Fear of movement and re-injury, and It was developed to evaluate avoidance behavior due to fear. It was adapted to Turkish by Yılmaz et al. in 2011 and tested for validity and reliability. study has been done. The scale consists of 17 questions. On the scale, "1" means "strongly disagree" and "2" means "strongly disagree." from "1" to "4", where "I disagree", "3" I agree, "4" I completely agree. Varying Likert scoring is used. An individual can get a total score between 17-68, A high score indicates that the individual has high kinesiophobia.
Measured: day 1
Dysmenorrhea Affect Scale
Validity and reliability study by Gün (2014) The Dysmenorrhea Exposure Scale (DES) was used to measure women's periods of menstrual pain. It is designed to identify problems and coping methods. A total of items 39 and 11 It consists of sub-dimensions. The Cronbach's Alpha coefficient of the scale is 0.90. Participants each rated the item on a 5-point scale ranging from 'I totally disagree (1)' to 'I totally agree (5)'. It evaluates on a Likert type scale. As the score obtained from the scale increases, people's The level of being affected by dysmenorrhea also increases. The lowest score that can be obtained from the scale is , The highest score is 195.
Measured: day 1
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, 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: day 1
Secondary outcomes (3)
Tampa Kinesiophobia Scale
Tampa Kinesiophobia Scale (TCS) Miller, Kori and Todd It is a scale developed by in 1991. Fear of movement and re-injury, and It was developed to evaluate avoidance behavior due to fear. It was adapted to Turkish by Yılmaz et al. in 2011 and tested for validity and reliability. study has been done. The scale consists of 17 questions. On the scale, "1" means "strongly disagree" and "2" means "strongly disagree." from "1" to "4", where "I disagree", "3" I agree, "4" I completely agree. Varying Likert scoring is used. An individual can get a total score between 17-68, A high score indicates that the individual has high kinesiophobia.
Measured: up to 4 weeks
Dysmenorrhea Affect Scale
Validity and reliability study by Gün (2014) The Dysmenorrhea Exposure Scale (DES) was used to measure women's periods of menstrual pain. It is designed to identify problems and coping methods. A total of items 39 and 11 It consists of sub-dimensions. The Cronbach's Alpha coefficient of the scale is 0.90. Participants each rated the item on a 5-point scale ranging from 'I totally disagree (1)' to 'I totally agree (5)'. It evaluates on a Likert type scale. As the score obtained from the scale increases, people's The level of being affected by dysmenorrhea also increases. The lowest score that can be obtained from the scale is , The highest score is 195.
Measured: up to 4 weeks
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, 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: up to 4 weeks
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 start1 Dec 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 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
- NCT07097285
- Sponsor's protocol ID
- SBÜ-AYDINKARTAL-015
- Status last verified
- Jul 2025
- First submitted
- 8 Dec 2024
- Last updated
- 22 Aug 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 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sensory Awareness Training Given to Women of Reproductive Age on Dysmenorrhea and Kinesiophobia
- ClinicalTrials.gov ID
- NCT07097285
- Acronym / sponsor ID
- SBÜ-AYDINKARTAL-015
- Conditions
- Dysmenorrhea, Kinesiophobia
- Keywords
- Sensory Awareness, Dysmenorrhea, Kinesiophobia, Reproductive, Women
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (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 use of web-based sensory awareness training given to women of reproductive age. It was planned to examine the effect of dysmenorrhea level and kinzeophobia status.H0a = Body weight of women of reproductive age who received and did not receive sensory awareness training. There is no difference between awareness levels.
H1a = Body size of women of reproductive age who receive and do not receive sensory awareness training. There is a difference between awareness levels.
H0b = Dysmenorrhea of women of reproductive age who received or did not receive sensory awareness training. There is no difference between the levels.
H1b = Dysmenorrhea among women of reproductive age who received and did not receive sensory awareness training. There is a difference between the levels.
H0c = Kinesiophobia in women of childbearing age who received or did not receive sensory awareness training. There is no difference between the situations.
H1c = Kinesiophobia in women of reproductive age who receive and do not receive sensory awareness training. There is a difference between situations Sensory awareness training was given to women in the intervention group of the study for 4 weeks. will be given. Training contents, Sensory System Training Presentation, Proprioception and Kinesthesia Sensory Training Presentation, Interoception Sense Training Presentation will be given, then Graded Sensory Discrimination, Graded Motor Imagery (DMI), interoception awareness training, body training with training consisting of interoceptive awareness exercises and home exercise programs. A protocol for awareness training will be implemented.
Detailed description
Sensory awareness training was given to women in the intervention group of the study for 4 weeks will be given. Training contents, Sensory System Training Presentation, Proprioception and Kinesthesia Sensory Training Presentation, Interoception Sense Training Presentation will be given, then Graded Sensory Discrimination, Graded Motor Imagery (DMI), interoception awareness training, body training with training consisting of interoceptive awareness exercises and home exercise programs.
A protocol for awareness training will be implemented. Each training is 60 minutes long will be planned. Women who volunteered to participate in the study and were assigned to the intervention group An informational meeting will be held before the training. 4 weeks from pre-training and first training "Tampa Kinesiophobia Scale (TKÖ)" "Dysmenorrhea Affectedness Scale" and "Very Dimensional Body Awareness Assessment-II Scale" will be applied. be once a week Each training period is limited to 60 minutes. Research forms were given to participants face to face. will be implemented.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care (n:40) | No intervention | –No intervention will be made to the control group. |
| sensory awareness training (n:40) | Experimental | Behavioral: sensory awareness trainingSensory awareness training was given to women in the intervention group of the study for 4 weeks. will be given. Each training is 60 minutes long will be planned. 4 weeks from pre-training and first training "Tampa Kinesiophobia Scale (TKÖ)" "Dysmenorrhea Affectedness Scale" and "Very Dimensional Body Awareness Assessment-II Scale" will be applied. be once a week Each training period is limited to 60 minutes. Research forms were given to participants face to face. will be implemented. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteering to participate in research
- Having a complaint of dysmonea
- Being of childbearing age
- Being over 19 years old
- Having internet access
Key exclusion criteria (4 listed)
- Be pregnant
- Having any disease that affects the menstrual period
- Using oral contraceptives
- Using intrauterine device
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 |
|---|---|---|
| sensory awareness trainingPresentations 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. Graded Sensory Discrimination protocol, localization training It includes level 1, localization training level 2 and graphesthesia training. Graded Engine Visualization (DMI) protocol includes right/left discrimination training and visual imagery training. | Behavioural | sensory awareness training (n:40) |
Primary outcome
Introductory Information Form
Time frame: Baseline
In this form created by researchers based on the literature, There are questions about the participants' age, the high school they graduated from, dysmenorrhea and kinesiophobia is taking.
Tampa Kinesiophobia Scale
Time frame: day 1
Tampa Kinesiophobia Scale (TCS) Miller, Kori and Todd It is a scale developed by in 1991. Fear of movement and re-injury, and It was developed to evaluate avoidance behavior due to fear. It was adapted to Turkish by Yılmaz et al. in 2011 and tested for validity and reliability. study has been done. The scale consists of 17 questions. On the scale, "1" means "strongly disagree" and "2" means "strongly disagree." from "1" to "4", where "I disagree", "3" I agree, "4" I completely agree. Varying Likert scoring is used. An individual can get a total score between 17-68, A high score indicates that the individual has high kinesiophobia.
Dysmenorrhea Affect Scale
Time frame: day 1
Validity and reliability study by Gün (2014) The Dysmenorrhea Exposure Scale (DES) was used to measure women's periods of menstrual pain. It is designed to identify problems and coping methods. A total of items 39 and 11 It consists of sub-dimensions. The Cronbach's Alpha coefficient of the scale is 0.90. Participants each rated the item on a 5-point scale ranging from 'I totally disagree (1)' to 'I totally agree (5)'. It evaluates on a Likert type scale. As the score obtained from the scale increases, people's The level of being affected by dysmenorrhea also increases. The lowest score that can be obtained from the scale is , The highest score is 195.
Multidimensional Body Awareness Assessment-II Scale
Time frame: day 1
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, 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.
3 secondary outcomes
Tampa Kinesiophobia Scale
Time frame: up to 4 weeks
Dysmenorrhea Affect Scale
Time frame: up to 4 weeks
Multidimensional Body Awareness Assessment-II Scale
Time frame: up to 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 22 Aug 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 sensory awareness training in people with Dysmenorrhea and Kinesiophobia, 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 6 inclusion and 4 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 22 Aug 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: Baseline). The study lists 4 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 22 Aug 2025.