- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07080580
- Original Trial
Vibration-Assisted Core Exercises for Primary Dysmenorrhea
Effects of Vibration-Assisted Core Stabilization Exercises on Menstrual Symptoms, Pain, and Quality of Life in Women With Primary Dysmenorrhea: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tuzla
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Istanbul, Tuzla, Turkey, 34959
- Istanbul Okan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control Group
No intervention was applied to the control group.
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Experimental: Whole Body Vibration
The 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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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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.
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First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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Menstruation Symptoms (Menstruation Symptom Scale)
Time Frame: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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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.
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First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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Menstruation Attitudes (Menstruation Attitude Questionnaire)
Time Frame: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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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.
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First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Intensity (Visual Analog Scale)
Time Frame: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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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.
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First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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Quality of Life Assessment (Short Form-36 Scale)
Time Frame: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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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.
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First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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Trunk endurance assessment (Sorenson Test)
Time Frame: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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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.
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First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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Trunk endurance assessment (Sit-up testi)
Time Frame: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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In the sit-up test, the maximum number of correct repetitions that the subjects perform within a 30-second time period is recorded.
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First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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Trunk endurance assessment (Lateral Bridge Test-Right and Left)
Time Frame: First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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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.
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First 48 hours of the menstrual cycle (pre-intervention), week 4 (post-intervention), week 8 (post-intervention)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: EBRU ALOĞLU ÇİFTÇİ, Lecturer, Okan University
Publications and helpful links
General 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.
- Hoseini, M., Gharahtapeh, S. R., Jahazi, A. 2015 "Effect Of Vibration And Heat Combination On Primary Dysmenorrhea" Bali Medical Journal, 4(1), 12-16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EAloglu02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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