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Dysmenorrhea PrimaryNCT07080580

Vibration-Assisted Core Exercises for Primary Dysmenorrhea

A study testing Core exercises performed simultaneously on a whole body vibration platform in people with Dysmenorrhea Primary, run by Ebru Aloğlu Çiftçi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the effects of core stabilization exercises performed on a vibration platform in young women with primary dysmenorrhea. The exercises are designed to help reduce menstrual symptoms and pain, and to improve attitudes toward menstruation, functional and emotional well-being, and quality of… Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Dysmenorrhea Primary
What is being tested?
Core exercises performed simultaneously on a whole body vibration platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Apr 2023to 17 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

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 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Being in the 18-28 age group.
  • Being diagnosed with primary dysmenorrhea on an ultrasound examination.
  • Having a Body Mass Index (BMI) between 19-24.9.
  • Describing pain intensity as 5 or higher on the VAS pain scale.
  • Having regular menstrual cycles (every 21-35 days and no intermenstrual bleeding) for the past 6 months.
  • Being willing to participate in the study.
Show all 9Show fewer
  • Being cooperative and oriented.
  • Not having had any fractures, dislocations, or joint injuries in the past 6 months.
  • Not having had any surgery in the past 6 months.

Who cannot join

  • Having a systemic or chronic disease,
  • Being a professional athlete,
  • Having secondary dysmenorrhea,
  • Using oral contraceptives,
  • Being pregnant,
  • Having an orthopedic, neurological, rheumatological, or cardiovascular problem that prevents exercise,
  • Having any balance problems (vertigo, etc.) that prevent exercise.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Okan University

    Istanbul, Tuzla, 34959

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Vibration-Assisted Core Stabilization Exercises on Menstrual Symptoms, Pain, and Quality of Life in Women With Primary Dysmenorrhea: A Randomized Controlled Trial

This study aims to evaluate the effects of core stabilization exercises performed on a vibration platform in young women with primary dysmenorrhea. The exercises are designed to help reduce menstrual symptoms and pain, and to improve attitudes toward menstruation, functional and emotional well-being, and quality of life. A total of 24 women participated in the study. Participants were assigned either to a group receiving vibration-assisted core exercises or to a control group receiving no intervention. The intervention lasted 8 weeks, with sessions held three times per week.

Read the detailed description

Primary dysmenorrhea (PD) is a common gynecological condition characterized by uterine-origin lower abdominal pain during or before menstruation in the absence of any pelvic pathology. This randomized controlled trial aims to investigate the effects of a core exercise (CE) program performed on a vibration-supported platform on pain intensity, menstrual attitudes, quality of life, and functional and emotional status in women with PD. A total of 24 women aged 18 to 35 years participated in the study. Participants were randomly assigned to either an intervention group (n=12) or a control group (n=12). The intervention group performed vibration-assisted CE on a portable platform three times per week for eight weeks. The control group received no intervention. All participants were evaluated within the first 48 hours of the menstrual cycle, with follow-up assessments at weeks 4, and a final evaluation at the end of week 8.

Being tested
Core exercises performed simultaneously on a whole body vibration platform
Keywords
Vibration, dysmenorrhea primary, core exercise, whole body vibration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Core exercises performed simultaneously on a whole body vibration platformBehavioural

    It's a method where individuals stand on a vibration-generating platform and the vibration is transmitted from the soles of their feet to the entire body. Its use in combination with exercise has become popular in recent years due to the hypergravity it creates, aiming to increase muscle strength and reduce pain.

    There is no standardized protocol for the frequency, amplitude, and frequency of vibration application. However, it is known that when applied at frequencies between 10-30 Hz, it has no negative side effects and is beneficial in managing pain. In our study, core exercises will be performed on a vibration platform at a frequency of 14 Hz with an amplitude of 8 mm.

Study groups in NCT07080580
Study groupRoleWhat they receive
Whole Body VibrationExperimentalThe vibration group performed core exercises with vibration at 8 mm amplitude and 14 Hz frequency, 3 days a week for 8 weeks (24 sessions). Each session lasted 45-60 minutes, including a 10-minute warm-up (walking) and a 5-minute cool-down (stretching). Vibration time started at 15 minutes and increased to 30 minutes. Eight core exercises (bridge exercise, plank, cat-camel exercise, crunches, side-bends, heel drops, squats, half push-ups) were applied, with repetitions increased every 2 weeks: 8 reps in weeks 1-2, 10 reps in weeks 3-4, 12 reps in weeks 5-6, and 15 reps in weeks 7-8. A 30-second rest was given between exercises.
Receives: Behavioral: Core exercises performed simultaneously on a whole body vibration platform
Control GroupNo interventionNo intervention was applied to the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional and Emotional Status Assessment (Functional and Emotional Dysmenorrhea Scale)

    The Functional and Emotional Dysmenorrhea Scale was used to assess participants' dysmenorrhea experiences functionally and emotionally. The scale is a Likert-type scale consisting of 14 items and two subscales. Each item can be scored from 1 to 5. Scoring criteria are: 1. Not at all like my situation, 2. Not at all like my situation, 3. Both similar and not like my situation, 4. Similar to my situation, 5. Very similar to my situation. As the total score on the scale increases, the extent to which individuals are functionally and emotionally affected by dysmenorrhea also increases.

    Measured: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)

  2. Menstruation Symptoms (Menstruation Symptom Scale)

    In our study, the Menstrual Symptom Scale, a useful tool for assessing menstrual symptoms in Turkish women and found to have adequate validity and reliability, was used to assess participants' symptoms. The scale consists of 22 items developed to assess dysmenorrhea and its symptoms. Each item can be scored from 1 to 5. Scoring criteria range from 1 (never) to 5 (always). It consists of three subscales: items 1-13 address negative effects/somatic complaints, items 14-19 address menstrual pain symptoms, and items 20-22 address coping strategies. The subscale score is calculated by calculating the total mean score of the items in the subscales. A higher mean score for a subscale indicates an increase in the severity of menstrual symptoms related to that subscale. The mean score calculated from the scale is directly proportional to the severity of menstrual symptoms.

    Measured: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)

  3. Menstruation Attitudes (Menstruation Attitude Questionnaire)

    In our study, we used the Menstruation Attitude Questionnaire to measure attitudes toward menstruation in individuals with dysmenorrhea and varying socio-demographic characteristics. The scale is a Likert-type scale consisting of 33 items and 5 subscales. Each item is scored from 1 to 5. Scoring criteria range from 1 (Strongly disagree) to 5 (Strongly agree). The subscales and number of items are as follows: 1. Menstruation as a debilitating phenomenon (12 items); 2. Menstruation as a disturbing phenomenon (6 items); 3. Menstruation as a natural phenomenon (5 items); 4. Precognition/Anticipation of menstruation (5 items); and 5. Denial of the effects of menstruation (7 items). A high mean score on the Menstruation Attitude Questionnaire is directly proportional to the positive attitude toward menstruation.

    Measured: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)

Secondary outcomes (5)
  1. Pain Intensity (Visual Analog Scale)

    VAS is a frequently used assessment method for converting the intensity of pain, which cannot be measured numerically, into numerical data. Pain intensity is assessed on a scale from 0 to 10, with 0 indicating no pain and 10 indicating unbearable pain.

    Measured: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)

  2. Quality of Life Assessment (Short Form-36 Scale)

    The SF-36 is a self-assessment tool consisting of eight subscales and 36 questions. This tool is grouped to assess participants' physical functioning (10 items), physical limitations (4 items), emotional limitations (3 items), pain limitations (2 items), vitality (4 items), social functioning (2 items), mental health (5 items), and general health (5 items). Each subscale can be scored from 0 to 100. In this scoring system, 0 represents the lowest quality of life, and 100 represents the best.

    Measured: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)

  3. Trunk endurance assessment (Sorenson Test)

    In the Sorenson Test, participants were positioned prone, their pelvises positioned at the edge of the table, and their ankles were stabilized. The upper extremities were positioned next to the torso. The time the participant could maintain the horizontal position was measured with a stopwatch. The test was terminated if the position could not be maintained.

    Measured: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)

  4. Trunk endurance assessment (Sit-up testi)

    In the sit-up test, the maximum number of correct repetitions that the subjects perform within a 30-second time period is recorded.

    Measured: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)

  5. Trunk endurance assessment (Lateral Bridge Test-Right and Left)

    The Side Bridge Test was performed to assess the endurance of the spinal stabilizer muscles. Participants were positioned in a side-lying position. They were asked to lift their hips until the pelvis and trunk were horizontal. The time the position was maintained was measured with a stopwatch, and the assessment was performed on both sides.

    Measured: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start20 Apr 2023
  3. Primary completion17 Aug 2024
  4. Study completion17 Sep 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07080580
Sponsor's protocol ID
EAloglu02
Status last verified
Jul 2025
First submitted
15 Jul 2025
Last updated
25 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The study will share de-identified, summary-level outcome data, including group-level means, standard deviations, effect sizes, and p-values derived from statistical analyses.

Publications

  • Lefebvre G, Pinsonneault O, Antao V, Black A, Burnett M, Feldman K, Lea R, Robert M; SOGC. Primary dysmenorrhea consensus guideline. J Obstet Gynaecol Can. 2005 Dec;27(12):1117-46. doi: 10.1016/s1701-2163(16)30395-4. English, French.

    PubMed 16524531
  • Hoseini, M., Gharahtapeh, S. R., Jahazi, A. 2015 "Effect Of Vibration And Heat Combination On Primary Dysmenorrhea" Bali Medical Journal, 4(1), 12-16.

Questions about this trial

What is this clinical trial studying?

A study testing Core exercises performed simultaneously on a whole body vibration platform in people with Dysmenorrhea Primary, run by Ebru Aloğlu Çiftçi 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 9 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: finished, as of the sponsor's last update on 25 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Functional and Emotional Status Assessment (Functional and Emotional Dysmenorrhea Scale) (time frame: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)). 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?

On the ClinicalTrials.gov record for NCT07080580, which also lists 2 linked publications.

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 25 Jul 2025.

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