NCT07080580

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

July 15, 2025

Last Update Submit

July 22, 2025

Conditions

Keywords

Vibrationdysmenorrhea primarycore exercisewhole body vibration

Outcome Measures

Primary Outcomes (3)

  • 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.

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

  • 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.

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

  • 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.

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

Secondary Outcomes (5)

  • Pain Intensity (Visual Analog Scale)

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

  • Quality of Life Assessment (Short Form-36 Scale)

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

  • Trunk endurance assessment (Sorenson Test)

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

  • Trunk endurance assessment (Sit-up testi)

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

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

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

Study Arms (2)

Whole Body Vibration

EXPERIMENTAL

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.

Behavioral: Core exercises performed simultaneously on a whole body vibration platform

Control Group

NO INTERVENTION

No intervention was applied to the control group.

Interventions

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.

Whole Body Vibration

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Okan University

Istanbul, Tuzla, 34959, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

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

    BACKGROUND

Study Officials

  • EBRU ALOĞLU ÇİFTÇİ, Lecturer

    Okan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 15, 2025

First Posted

July 23, 2025

Study Start

April 20, 2023

Primary Completion

August 17, 2024

Study Completion

September 17, 2024

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Summary-level data and supporting documents (e.g., study protocol and statistical analysis plan) will be available within 12 months following the final publication of study results.
Access Criteria
The study's outcome results, including group-level means, standard deviations, p-values, and effect sizes, as well as supporting materials such as the study protocol and statistical analysis plan, will be made available to qualified academic researchers upon reasonable request.

Locations