Pelvic Floor AwarenessNCT07443423
The Effect of Training Based on the Transtheoretical Model on Pelvic Floor Muscle Strength
A study testing TRAINING BASED ON THE TRANSTEOROTİK MODEL and Not providing training in people with Pelvic Floor Awareness, run by Aynur Erçek Karci.
Trial summary
The study was designed to evaluate the effect of training based on the transtheoretical model on pelvic floor muscle strength in women. The study was designed as a randomized controlled single-blind experimental study with pre-test and post-test measurements and will be conducted with sexually active women aged 18 and… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Awareness
- What is being tested?
- TRAINING BASED ON THE TRANSTEOROTİK MODEL and Not providing training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Aug 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sexually active women aged 18-65
- Women who volunteered to participate in the study
Who cannot join
- Those with a perinometer measurement result of 2
- Pregnant women
- Those who have undergone pelvic floor muscle training in the last two years
- Those with conditions that prevent them from performing Pelvic Floor Muscle Exercises
- Those who use a mobile application for Pelvic Floor Muscle Exercises
- Those with Pelvic Floor Dysfunction
- Those who are unable to perform the Pelvic Floor exercise program -
About this study
Official title: The Effect of Transtheoretical Model-Based Training on Pelvic Floor Muscle Strength in Women: Creating an Application-Oriented Training Model
The study was designed to evaluate the effect of training based on the transtheoretical model on pelvic floor muscle strength in women.
The study was designed as a randomized controlled single-blind experimental study with pre-test and post-test measurements and will be conducted with sexually active women aged 18 and over who meet the inclusion criteria and who applied to the Sevgi Family Health Center No. 13 in Gaziemir District, Izmir Province.
Read the detailed description
The pelvic floor is a complex anatomical structure composed of nerve, muscle, fascia, and connective tissue components. Working in conjunction with other muscles associated with the pelvic girdle, the pelvic floor is a vital component responsible for stabilizing the entire body. The primary functions of the pelvic floor and its components include providing support to intra-abdominal structures such as the bladder, urethra, prostate, vagina, uterus, anus, and rectum; supporting continence by enabling the voluntary initiation and cessation of urination and defecation, thus preventing incontinence; preventing pelvic organ prolapse; playing an active role during childbirth; and maintaining sexual function .
Pelvic floor dysfunction (PFD) manifests with various complex symptoms such as urinary incontinence (UI), pelvic organ prolapse (POP), fecal incontinence (FI), sexual problems, and chronic pelvic pain, alongside damage, weakening, and impairment of the pelvic floor's function and morphological structure. affecting women's daily activities, psychosocial status, and overall health perception . Pelvic floor dysfunction is a common problem worldwide, occurring at rates ranging from 1.9% to 46.5%, and is underdiagnosed. In Turkey, the prevalence of pelvic organ prolapse is 30-50%, urinary incontinence is 26.3-71.5%, and fecal/anal incontinence is reported in the literature as 2-3%. it is reported that this rate increases with age, exceeding 10%, and that the rate of sexual dysfunction in women ranges from 20% to 73% stated in their article that approximately 10% of women face pelvic floor problems requiring surgery . Although it varies between countries and societies, the prevalence of pelvic floor dysfunction in women generally ranges between 20-40% .These rates indicate that pelvic floor dysfunction is a significant public health issue.
The treatment and care interventions for pelvic floor dysfunction are a preventive health service that healthcare professionals, particularly midwives in primary healthcare institutions, should prioritize. Providing education on pelvic floor strengthening is important both in preventing misconceptions and in increasing women's knowledge and awareness levels.
A systematic review conducted to determine the effectiveness of health promotion interventions based on behavioral change models for modifying lifestyle factors (physical activity, diet, alcohol, and smoking) in adults receiving primary health care found that the Transtheoretical Model was the most frequently used intervention for these purposes. The Transtheoretical Model was developed by Prochaska and Diclemente to guide individuals in accepting problematic behaviors in their lives and changing these behaviors with positive expectations and desire. This model aims to change the individual's behavior intentionally. It is recommended that the Transtheoretical Model be used to facilitate individuals' adaptation to lifestyle changes and to provide effective education also stated in their studies that care provided in conjunction with pelvic floor training prevents pelvic floor dysfunction and improves quality of life .
- Conditions
- Pelvic Floor Awareness
- Being tested
- TRAINING BASED ON THE TRANSTEOROTİK MODEL, Not providing training
- Keywords
- Pelvic Floor Exercises, Transtheoretical Model, Randomized Controlled Trial, Health Education, Quality of Life
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAINING BASED ON THE TRANSTEOROTİK MODELOther
Women in the intervention group will receive awareness training on pelvic floor muscle exercises based on the transtheoretical model.
This training includes a brochure and a seminar program prepared according to the transtheoretical model.
A monthly exercise schedule will be provided to the women in this group to support them in performing pelvic floor muscle exercises.
Not providing trainingOther
Once the data collection phase of the study is complete, women in the control group will also be given a detailed explanation of pelvic floor muscle exercises based on the transtheoretical model and awareness training, and will be provided with a brochure.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Group not receiving training Receives: Other: Not providing training |
| Experimental group | Experimental | Not described Receives: Other: TRAINING BASED ON THE TRANSTEOROTİK MODEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pelvic floor muscle activity (Microvolts µV)
The maximum voluntary contraction (MVC) and average contraction of the pelvic floor muscles will be measured using a surface EMG biofeedback device.Higher values indicate improved muscle activation and strength.
Measured: Baseline (week 0) and Post-intervention( week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor AwarenessStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aynur Erçek Karci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aynur Erçek Karci, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443423
- Sponsor's protocol ID
- 26-1T/83
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article (text, tables,figures and appendices) will be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transtheoretical Model-Based Training on Pelvic Floor Muscle Strength in Women: Creating an Application-Oriented Training Model
- ClinicalTrials.gov ID
- NCT07443423
- Acronym / sponsor ID
- 26-1T/83
- Conditions
- Pelvic Floor Awareness
- Keywords
- Pelvic Floor Exercises, Transtheoretical Model, Randomized Controlled Trial, Health Education, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Aynur Erçek KarciUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 2 Mar 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.
The study was designed to evaluate the effect of training based on the transtheoretical model on pelvic floor muscle strength in women.
The study was designed as a randomized controlled single-blind experimental study with pre-test and post-test measurements and will be conducted with sexually active women aged 18 and over who meet the inclusion criteria and who applied to the Sevgi Family Health Center No. 13 in Gaziemir District, Izmir Province.
Detailed description
The pelvic floor is a complex anatomical structure composed of nerve, muscle, fascia, and connective tissue components. Working in conjunction with other muscles associated with the pelvic girdle, the pelvic floor is a vital component responsible for stabilizing the entire body. The primary functions of the pelvic floor and its components include providing support to intra-abdominal structures such as the bladder, urethra, prostate, vagina, uterus, anus, and rectum; supporting continence by enabling the voluntary initiation and cessation of urination and defecation, thus preventing incontinence; preventing pelvic organ prolapse; playing an active role during childbirth; and maintaining sexual function .
Pelvic floor dysfunction (PFD) manifests with various complex symptoms such as urinary incontinence (UI), pelvic organ prolapse (POP), fecal incontinence (FI), sexual problems, and chronic pelvic pain, alongside damage, weakening, and impairment of the pelvic floor's function and morphological structure. affecting women's daily activities, psychosocial status, and overall health perception . Pelvic floor dysfunction is a common problem worldwide, occurring at rates ranging from 1.9% to 46.5%, and is underdiagnosed. In Turkey, the prevalence of pelvic organ prolapse is 30-50%, urinary incontinence is 26.3-71.5%, and fecal/anal incontinence is reported in the literature as 2-3%. it is reported that this rate increases with age, exceeding 10%, and that the rate of sexual dysfunction in women ranges from 20% to 73% stated in their article that approximately 10% of women face pelvic floor problems requiring surgery . Although it varies between countries and societies, the prevalence of pelvic floor dysfunction in women generally ranges between 20-40% .These rates indicate that pelvic floor dysfunction is a significant public health issue.
The treatment and care interventions for pelvic floor dysfunction are a preventive health service that healthcare professionals, particularly midwives in primary healthcare institutions, should prioritize. Providing education on pelvic floor strengthening is important both in preventing misconceptions and in increasing women's knowledge and awareness levels.
A systematic review conducted to determine the effectiveness of health promotion interventions based on behavioral change models for modifying lifestyle factors (physical activity, diet, alcohol, and smoking) in adults receiving primary health care found that the Transtheoretical Model was the most frequently used intervention for these purposes. The Transtheoretical Model was developed by Prochaska and Diclemente to guide individuals in accepting problematic behaviors in their lives and changing these behaviors with positive expectations and desire. This model aims to change the individual's behavior intentionally. It is recommended that the Transtheoretical Model be used to facilitate individuals' adaptation to lifestyle changes and to provide effective education also stated in their studies that care provided in conjunction with pelvic floor training prevents pelvic floor dysfunction and improves quality of life .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Not providing trainingGroup not receiving training |
| Experimental group | Experimental | Other: TRAINING BASED ON THE TRANSTEOROTİK MODEL |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sexually active women aged 18-65
- Women who volunteered to participate in the study
Key exclusion criteria (7 listed)
- Those with a perinometer measurement result of 2
- Pregnant women
- Those who have undergone pelvic floor muscle training in the last two years
- Those with conditions that prevent them from performing Pelvic Floor Muscle Exercises
- Those who use a mobile application for Pelvic Floor Muscle Exercises
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 |
|---|---|---|
| TRAINING BASED ON THE TRANSTEOROTİK MODELWomen in the intervention group will receive awareness training on pelvic floor muscle exercises based on the transtheoretical model. This training includes a brochure and a seminar program prepared according to the transtheoretical model. A monthly exercise schedule will be provided to the women in this group to support them in performing pelvic floor muscle exercises. | Other | Experimental group |
| Not providing trainingOnce the data collection phase of the study is complete, women in the control group will also be given a detailed explanation of pelvic floor muscle exercises based on the transtheoretical model and awareness training, and will be provided with a brochure. | Other | Control Group |
Primary outcome
Change in pelvic floor muscle activity (Microvolts µV)
Time frame: Baseline (week 0) and Post-intervention( week 8)
The maximum voluntary contraction (MVC) and average contraction of the pelvic floor muscles will be measured using a surface EMG biofeedback device.Higher values indicate improved muscle activation and strength.
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 2 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this article (text, tables,figures and appendices) will be shared
Related trials for Pelvic Floor Awareness
Not yet recruiting
Pain Neuroscience Education and Basic Body Awareness Therapy in Women With Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome, Female
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TRAINING BASED ON THE TRANSTEOROTİK MODEL and Not providing training in people with Pelvic Floor Awareness, run by Aynur Erçek Karci.
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 2 inclusion and 7 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pelvic floor muscle activity (Microvolts µV) (time frame: Baseline (week 0) and Post-intervention( week 8)). 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 2 Mar 2026.