NCT06011928

Brief Summary

The aim of this study is to compare the effects of motor imagery focused pelvic floor exercises and relaxation exercises used in the treatment of dysmenorrhea on pain and menstrual symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

August 3, 2023

Last Update Submit

November 5, 2023

Conditions

Keywords

DysmenorrheaMenstrual symptomImaginationRelaxationPelvic floor exercisesexercise

Outcome Measures

Primary Outcomes (4)

  • Visual Analogue Scale

    The VAS was used on the most severe day of the menstrual cycle to determine the severity of pain, which is one of the inclusion criteria of the participants before starting the study. Subjects were asked to mark the degree of pain they felt on a straight line of 100 millimeters (mm). A 0 at the beginning means no pain and a maximum of 10 at the end of the line means unbearable pain. The point determined on the line expresses the intensity of pain that people feel during menstruation.

    10 weeks

  • McGill pain questionnaire- short form

    It is a questionnaire used to describe the severity and quality of the pain that a person feels during menstruation. A high score indicates a high level of pain. The questionnaire consists of three parts. In the first part, there are 15 descriptive word groups, 11 of which are to evaluate the emotional/perceptual dimension of pain and 4 to evaluate the emotional/emotional dimension of pain. Words are rated from 0 to 3 (0= None at all, 1= Mild, 2=Moderate, 3= Severe). In the first part, three pain scores are obtained: sensory pain score, perceptual pain score and total pain score. Pain quality scores are obtained with sensory/perceptual 0-33 points, emotional/emotional 0-12 points, and a total of 0-45 points. The second part is the display of the pain intensity of his work on a scale. A low value indicates a low level of pain, and a high value indicates severe. The third section has five word groups ranging from 'mild pain' to 'unbearable pain' to describe one's pain.

    10 weeks

  • Menstruation attitude scale (MBI)

    It is used to evaluate the positive / negative aspects of menstruation. The scale is a Likert-type scale consisting of 33 items and five subscales. The subscales and the items of the subscales are as follows: * Menstruation as a debilitating phenomenon (12 items), * Menstruation as a disturbing phenomenon (6 items), * Menstruation as a natural phenomenon (5 items), * Noticing/anticipating that menstruation will occur (5 items), * Denial of the effects of menstruation (7 items) The scale is evaluated by scoring between 1 and 7, and the Turkish form has been converted into scoring between 1 and 5. Participants are asked to mark the most appropriate option (1. Strongly disagree, 2. Disagree, 3. Undecided, 4. Agree, 5. Totally agree).

    10 weeks

  • Functional and emotional dysmenorrhea scale (FEDS)

    Evaluates dysmenorrhea functionally and emotionally. It consists of 14 items and 2 sub-dimensions. In the scale, each item is scored between 1 and 5 (1. Not at all similar to my situation, 2. Not similar to my situation, 3. Similar or not similar to my situation, 4. Considered similar to my situation, 5. Very similar to my situation). The presence of a high score indicates that the level of functional and emotional impact of dysmenorrhea is high.

    10 weeks

Study Arms (3)

Motor imagery focused pelvic floor exercise (MOPEXE)

ACTIVE COMPARATOR

Internal imagery technique, one of the imagery techniques, will be applied to the participants. Exercise program 8 weeks, 3 days a week, 3 sets of 10 repetitions of each movement and between sets It is planned to rest for 10 seconds.

Other: MOPEX Exercise

Relaxation exercise (RE) group

ACTIVE COMPARATOR

One of the relaxation methods, Progressive Relaxation Exercises will be used.Exercises will be required to be applied 3 days a week, as 1 set of 10 repetitions per day.

Other: Relaxation Exercise

Combined exercise group (CEG)

ACTIVE COMPARATOR

With the video home exercise program, the participants performed progressive relaxation exercises, respectively. then they will be provided with motor imagery focused pelvic floor exercises. A rest period of 5 minutes will be applied between two different exercise programs.

Other: Combine Exercise

Interventions

Exercises to be done in order: 1. Pelvic tilt in supine position 2. Bridge building 3. Pelvic stretching 4. Ball spin 5. Cat-camel exercise Exercise program 8 weeks, 3 days a week, 3 sets of 10 repetitions of each movement and between sets It is planned to rest for 10 seconds

Motor imagery focused pelvic floor exercise (MOPEXE)

Progressive muscle relaxation exercises, respectively, facial muscles, neck and shoulders, right-left arm, right-left hand, back muscles, chest muscles, abdominal muscles, hip, right-left leg, right-left foot muscles are contracted while breathing deeply and slowly, and relaxing when exhaling. will be displayed. Each muscle is contracted for 5 seconds and relaxed for 10 seconds. will be held. Before moving on to the new muscle group in intermuscular contraction and relaxation, several times in between Slow and deep breathing will be practiced. After all the muscles are contracted and relaxed in sequence, Then, while inhaling, all the muscles contract simultaneously and while exhaling, will be loosened.

Relaxation exercise (RE) group

Exercises to be done in order: Pelvic tilt in supine position Bridge building Pelvic stretching Ball spin Cat-camel exercise Exercise program 8 weeks, 3 days a week, 3 sets of 10 repetitions of each movement and between sets It is planned to rest for 10 seconds. Progressive muscle relaxation exercises, respectively, facial muscles, neck and shoulders, right-left arm, right-left hand, back muscles, chest muscles, abdominal muscles, hip, right-left leg, right-left foot muscles are contracted while breathing deeply and slowly, and relaxing when exhaling. will be displayed. Each muscle is contracted for 5 seconds and relaxed for 10 seconds. will be held. Before moving on to the new muscle group in intermuscular contraction and relaxation, several times in between Slow and deep breathing will be practiced. After all the muscles are contracted and relaxed in sequence, Then, while inhaling, all the muscles contract simultaneously and while exhaling, will be loosened.

Combined exercise group (CEG)

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsdysmenorrhea is a female disease
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having a normal menstrual cycle (24-35 days),
  • never having given birth
  • According to the Visual Analogue Scale (VAS), the pain level during the menstruation period is 10.
  • to give a score of 5 or more out of cooperative and oriented
  • Volunteer to participate in the study.

You may not qualify if:

  • Having an active sexual life
  • Receiving psychiatric treatment for stress disorder or anxiety, using birth control pills,
  • Those with irregular menstrual cycles (less than 21 days or longer than 35 days)
  • those with a menstrual cycle period),
  • undergoing any gynecological surgery,
  • A mental, cardiovascular, pulmonary, or orthopedic disorder that may interfere with exercise have a disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üsküdar Unıversıty

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • McKenna KA, Fogleman CD. Dysmenorrhea. Am Fam Physician. 2021 Aug 1;104(2):164-170.

    PMID: 34383437BACKGROUND
  • Boztas Elverisli G, Armagan N, Atilgan E. Comparison of the efficacy of pharmacological and nonpharmacological treatments in women with primary dysmenorrhea: randomized controlled parallel-group study. Ginekol Pol. 2023;94(9):687-697. doi: 10.5603/GP.a2022.0009. Epub 2022 Apr 14.

    PMID: 35419791BACKGROUND
  • Daley AJ. Exercise and primary dysmenorrhoea : a comprehensive and critical review of the literature. Sports Med. 2008;38(8):659-70. doi: 10.2165/00007256-200838080-00004.

    PMID: 18620466BACKGROUND
  • Armour M, Ee CC, Naidoo D, Ayati Z, Chalmers KJ, Steel KA, de Manincor MJ, Delshad E. Exercise for dysmenorrhoea. Cochrane Database Syst Rev. 2019 Sep 20;9(9):CD004142. doi: 10.1002/14651858.CD004142.pub4.

    PMID: 31538328BACKGROUND
  • Fuentes-Aparicio L, Cuenca-Martinez F, Munoz-Gomez E, Molla-Casanova S, Aguilar-Rodriguez M, Sempere-Rubio N. Effects of therapeutic exercise in primary dysmenorrhea: an umbrella and mapping review. Pain Med. 2023 Dec 1;24(12):1386-1395. doi: 10.1093/pm/pnad104.

    PMID: 37555833BACKGROUND
  • Lopez-Liria R, Torres-Alamo L, Vega-Ramirez FA, Garcia-Luengo AV, Aguilar-Parra JM, Trigueros-Ramos R, Rocamora-Perez P. Efficacy of Physiotherapy Treatment in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 23;18(15):7832. doi: 10.3390/ijerph18157832.

    PMID: 34360122BACKGROUND

MeSH Terms

Conditions

DysmenorrheaGenital Diseases, FemaleMotor Activity

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and SymptomsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBehavior

Study Officials

  • Selda KOÇOĞLU

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor doctor

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 25, 2023

Study Start

September 1, 2023

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

November 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations