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Investigation of the Effect of Online Yoga Based Exercise Program on Women With Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise Program
Education Program
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Yoga, Telerehabilitation, Exercise, Online

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Being a nulliparous woman between the ages of 18-35,
  • Having a primary dysmenorrhea symptom,
  • Having a regular menstrual cycle (28 ± 7 days),
  • Menstrual pain Visual Analogue Scale score higher than 4 cm in the last 6 months

Exclusion Criteria:

  • Having gastrointestinal, urogynecological, autoimmune, psychiatric, neurological diseases or other chronic pain syndromes,
  • To have given birth, Current pregnancy status,
  • Using an intrauterine device and having had pelvic surgery,
  • Using drugs including oral contraceptives or antidepressants at least 6 months before the study,
  • Having an irregular menstrual cycle (those with a menstrual cycle shorter than 21 days or longer than 35 days)
  • A pathological history or ultrasonographic result showing secondary dysmenorrhea.

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Online Yoga Based Exercise Program

Education Program

Arm Description

A 50-minute online exercise program consisting of 5 categories will be created. The program will last 8 weeks, twice a week. In the first category, 20-30 seconds of stretching was applied to iliopsoas, hamstring, adductor, tensor fascia lata, piriformis, quadratus lumborum, quadriceps femoris and gastrocnemius muscles. In the second category, stabilization and pelvic mobilization exercises will be applied to the core muscles. Each exercise will be performed in 3 sets of 10 repetitions. In the third category, strengthening exercises will be done for the gluteal muscles, abdominal muscles, erector spine, quadriceps femoris and latissimus dorsi. Each exercise will be performed as 10 repetitions and 3 sets. In the fourth category, 3 sets and 10 repetitions of kegel exercises will be done. minute diaphragmatic breathing will be applied.

The informative training was given to both group members individually and online. In the training program; The female reproductive system organs, the structure of the pelvis, the location and functions of the pelvic floor muscles, the definition and physiology of menstruation, the types and risk factors of dysmenorrhea, the definition and symptoms of primary dysmenorrhea, treatment methods for coping with pain in primary dysmenorrhea were mentioned.

Outcomes

Primary Outcome Measures

Sociodemographic Evaluation
A personal data questionnaire was used, in which personal information and information about menstrual periods were questioned.
Pain Intensity
Visual Analogue Scale was used to measure the pain intensity. The visual analog scale consists of emotional adjectives that mark the level of pain experienced by the person at that moment with a vertical line on the plane. Participants were asked to rate their menstrual pain levels. Each emotion was evaluated between not experiencing that emotion at all (eg, I'm not nervous = 0) and being fully experienced (eg, I'm extremely nervous = 10).
Life Quality
Short Form-36 (SF36) questionnaire, evaluates general health and quality of life. The questionnaire has 36 questions and 8 subscales. Limitations in social activities due to physical health-related limitations, physical pain, general health perceptions, vitality, physical or emotional problems and general mental health are questioned. The answers of the questions are scored between 0 (low) and 100 (high). 0 means the lowest level of life and 100 the highest level of quality of life.
Menstrual Attitude
The Turkish version of the Menstrual Attitude Scale (MBI) consisting of 5 subscales and a total of 33 items was used to determine the attitudes and behaviors of women during the menstrual period.It was prepared in 1980, based on the view that attitudes about menstruation can be positive as well as negative, and expectations about physiological and emotional symptoms before or during menstruation can be effective in behaviors displayed during this period. Menstruation as a debilitating phenomenon (12 items); Menstruation as a disturbing phenomenon (6 items); Menstruation as a natural phenomenon (5 items); It is a scale consisting of 5 categories and 33 sub-items, including recognizing / anticipating that menstruation will occur (5 items) and denial of the effects of menstruation (7 items). Each item is scored between 1 (strongly disagree) and 5 (totally agree). The high scores obtained from the subscales in the Menstruation Attitude Scale indicate that the attitude towards menstruation
Body Awareness
Participants; The Body Awareness Questionnaire, which was developed by Shields et al. In 1989, was used to define body awareness, evaluate the effectiveness of the treatment, and determine its relationship with physical and emotional components. Body Awareness Questionnaire is defined as a tool with psychometric features that fully evaluates the concept of body awareness. It consists of 18 questions in total. Each question is scored between 1 (Not right at all for me) to 7 (Totally true for me). A high score in the questionnaire means high body awareness.
Satisfaction survey
Three questions about the satisfaction of the online exercise program applied at the end of the study were asked to the participants in the study group. Satisfaction with the treatment and the level of recommending the treatment to other patients were asked to be scored between 0 and 10, and if they had a choice, they were asked whether they would prefer an online or a face-to-face exercise program.
Weight
kg
Height
m

Secondary Outcome Measures

Full Information

First Posted
March 26, 2021
Last Updated
July 30, 2022
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05081869
Brief Title
Investigation of the Effect of Online Yoga Based Exercise Program on Women With Primary Dysmenorrhea
Official Title
Investigation of the Effect of Online Yoga Based Exercise Program on Women With Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dysmenorrhea; It is defined as painful menstrual bleeding and is included in the 10th Revision of International Disease Statistics and Related Health Problems published by the World Health Organization in 1992. In women with dysmenorrhea, pain usually begins within 1-2 years after menarche, is intermittent, cramp-like, predominantly in the suprapubic region, and may sometimes be accompanied by various symptoms such as diarrhea, nausea, and vomiting. The incidence of dysmenorrhea can often differ because most women suffering from this problem do not seek any health care services. Symptoms of the menstrual period may negatively affect women in all areas of life by causing various somatic and psychological problems. The state of being absent at least once at school or work due to symptoms of primary dysmenorrhea has been reported by 13-51% of women suffering from this condition. In the treatment of dysmenorrhea, the application of exercise to reduce the level of pain and alleviate the severity of symptoms was started by Mosler in 1914. Mosler demonstrated that exercise pumps blood to the uterus, thereby reducing menstrual pain. In later recent studies, it was found that exercise increases beta-endorphin hormone secretion, which has a natural pain reliever effect in the body; suggested that it reduces stress, pain, and prostaglandin levels. Therefore, the use of exercise as a therapy is thought to improve not only pain and mental health symptoms, but also the quality of life. As of March 11, 2020, since the World Health Organization defined Coronavirus Disease 2019 (COVID-19) as a pandemic. In the current epidemic process, the concept of "social distance" has been emphasized as the most important and basic way of reducing the risk of transmission from close contact, and the importance of choosing telerehabilitation has been emphasized once again. Online application of exercise programs can be defined as telerehabilitation, as the transmission of rehabilitation services over long distances by using electronic information and communication technology. In recent years, it has become one of the popular areas with the development of technology. Due to the limited number of studies on this subject in the literature, our study aimed to investigate the effect of the online yoga-based exercise program on women with primary dysmenorrhea.
Detailed Description
This study will be conducted online between March 2021 and May 2021 in their own settings for women with regular menstrual cycles to investigate the impact of online yoga-based exercise programs on women with primary dysmenorrhea. All participants will be given detailed information about the study and a written informed consent form will be signed that they agree to work voluntarily. The GPower program was used to determine the number of people to be included in the study and control groups. When the results of two studies similar to our study were evaluated in the literature review, it was seen that the Effect size d value for the VAS score was distributed between 0.17 and 2.06 and clustered around 1. When the effect size was d = 1, α = 0.05, Power (1-β) = 0.90 (90%) was taken in the GPower package program, and the minimum sample size was determined to be 50, 25 in the study and control groups. They will be randomly divided into two groups of 25 people each, according to the order of application. While an online yoga-based exercise program and an informative training program was applied to the experimental group from two randomly separated groups, only an informative training program will be given to the control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
Yoga, Telerehabilitation, Exercise, Online

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Fifty women with primary dysmenorrhea will be divided into two groups as study and control. The working group will be subjected to informative training and an online exercise program of 16 sessions. The control group will only receive information training.
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online Yoga Based Exercise Program
Arm Type
Experimental
Arm Description
A 50-minute online exercise program consisting of 5 categories will be created. The program will last 8 weeks, twice a week. In the first category, 20-30 seconds of stretching was applied to iliopsoas, hamstring, adductor, tensor fascia lata, piriformis, quadratus lumborum, quadriceps femoris and gastrocnemius muscles. In the second category, stabilization and pelvic mobilization exercises will be applied to the core muscles. Each exercise will be performed in 3 sets of 10 repetitions. In the third category, strengthening exercises will be done for the gluteal muscles, abdominal muscles, erector spine, quadriceps femoris and latissimus dorsi. Each exercise will be performed as 10 repetitions and 3 sets. In the fourth category, 3 sets and 10 repetitions of kegel exercises will be done. minute diaphragmatic breathing will be applied.
Arm Title
Education Program
Arm Type
Sham Comparator
Arm Description
The informative training was given to both group members individually and online. In the training program; The female reproductive system organs, the structure of the pelvis, the location and functions of the pelvic floor muscles, the definition and physiology of menstruation, the types and risk factors of dysmenorrhea, the definition and symptoms of primary dysmenorrhea, treatment methods for coping with pain in primary dysmenorrhea were mentioned.
Intervention Type
Other
Intervention Name(s)
Exercise Program
Intervention Description
An online yoga-based exercise program will be applied for 16 sessions in individuals' own environments. The exercise program will consist of stretching, mobilization, stabilization, strengthening and relaxation exercises.
Intervention Type
Other
Intervention Name(s)
Education Program
Intervention Description
There will be video training on the subject for both groups.
Primary Outcome Measure Information:
Title
Sociodemographic Evaluation
Description
A personal data questionnaire was used, in which personal information and information about menstrual periods were questioned.
Time Frame
At the baseline
Title
Pain Intensity
Description
Visual Analogue Scale was used to measure the pain intensity. The visual analog scale consists of emotional adjectives that mark the level of pain experienced by the person at that moment with a vertical line on the plane. Participants were asked to rate their menstrual pain levels. Each emotion was evaluated between not experiencing that emotion at all (eg, I'm not nervous = 0) and being fully experienced (eg, I'm extremely nervous = 10).
Time Frame
Change from Baseline pain intensity at 8 weeks
Title
Life Quality
Description
Short Form-36 (SF36) questionnaire, evaluates general health and quality of life. The questionnaire has 36 questions and 8 subscales. Limitations in social activities due to physical health-related limitations, physical pain, general health perceptions, vitality, physical or emotional problems and general mental health are questioned. The answers of the questions are scored between 0 (low) and 100 (high). 0 means the lowest level of life and 100 the highest level of quality of life.
Time Frame
Change from Baseline life quality at 8 weeks
Title
Menstrual Attitude
Description
The Turkish version of the Menstrual Attitude Scale (MBI) consisting of 5 subscales and a total of 33 items was used to determine the attitudes and behaviors of women during the menstrual period.It was prepared in 1980, based on the view that attitudes about menstruation can be positive as well as negative, and expectations about physiological and emotional symptoms before or during menstruation can be effective in behaviors displayed during this period. Menstruation as a debilitating phenomenon (12 items); Menstruation as a disturbing phenomenon (6 items); Menstruation as a natural phenomenon (5 items); It is a scale consisting of 5 categories and 33 sub-items, including recognizing / anticipating that menstruation will occur (5 items) and denial of the effects of menstruation (7 items). Each item is scored between 1 (strongly disagree) and 5 (totally agree). The high scores obtained from the subscales in the Menstruation Attitude Scale indicate that the attitude towards menstruation
Time Frame
Change from Baseline menstrual attitude at 8 weeks
Title
Body Awareness
Description
Participants; The Body Awareness Questionnaire, which was developed by Shields et al. In 1989, was used to define body awareness, evaluate the effectiveness of the treatment, and determine its relationship with physical and emotional components. Body Awareness Questionnaire is defined as a tool with psychometric features that fully evaluates the concept of body awareness. It consists of 18 questions in total. Each question is scored between 1 (Not right at all for me) to 7 (Totally true for me). A high score in the questionnaire means high body awareness.
Time Frame
Change from Baseline body awareness at 8 weeks
Title
Satisfaction survey
Description
Three questions about the satisfaction of the online exercise program applied at the end of the study were asked to the participants in the study group. Satisfaction with the treatment and the level of recommending the treatment to other patients were asked to be scored between 0 and 10, and if they had a choice, they were asked whether they would prefer an online or a face-to-face exercise program.
Time Frame
At the end of the 8 weeks
Title
Weight
Description
kg
Time Frame
At the baseline
Title
Height
Description
m
Time Frame
At the baseline

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being a nulliparous woman between the ages of 18-35, Having a primary dysmenorrhea symptom, Having a regular menstrual cycle (28 ± 7 days), Menstrual pain Visual Analogue Scale score higher than 4 cm in the last 6 months Exclusion Criteria: Having gastrointestinal, urogynecological, autoimmune, psychiatric, neurological diseases or other chronic pain syndromes, To have given birth, Current pregnancy status, Using an intrauterine device and having had pelvic surgery, Using drugs including oral contraceptives or antidepressants at least 6 months before the study, Having an irregular menstrual cycle (those with a menstrual cycle shorter than 21 days or longer than 35 days) A pathological history or ultrasonographic result showing secondary dysmenorrhea.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaren Çakmak
Organizational Affiliation
Istanbul Medipol University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10418884
Citation
Hillen TI, Grbavac SL, Johnston PJ, Straton JA, Keogh JM. Primary dysmenorrhea in young Western Australian women: prevalence, impact, and knowledge of treatment. J Adolesc Health. 1999 Jul;25(1):40-5. doi: 10.1016/s1054-139x(98)00147-5.
Results Reference
background
PubMed Identifier
9308868
Citation
Campbell MA, McGrath PJ. Use of medication by adolescents for the management of menstrual discomfort. Arch Pediatr Adolesc Med. 1997 Sep;151(9):905-13. doi: 10.1001/archpedi.1997.02170460043007.
Results Reference
background
PubMed Identifier
31673284
Citation
Hasanpour M, Mohammadi MM, Shareinia H. Effects of reflexology on premenstrual syndrome: a systematic review and meta-analysis. Biopsychosoc Med. 2019 Oct 24;13:25. doi: 10.1186/s13030-019-0165-0. eCollection 2019.
Results Reference
result
PubMed Identifier
32151612
Citation
Li R, Li B, Kreher DA, Benjamin AR, Gubbels A, Smith SM. Association between dysmenorrhea and chronic pain: a systematic review and meta-analysis of population-based studies. Am J Obstet Gynecol. 2020 Sep;223(3):350-371. doi: 10.1016/j.ajog.2020.03.002. Epub 2020 Mar 7.
Results Reference
result
PubMed Identifier
25243766
Citation
Kannan P, Claydon LS, Miller D, Chapple CM. Vigorous exercises in the management of primary dysmenorrhea: a feasibility study. Disabil Rehabil. 2015;37(15):1334-9. doi: 10.3109/09638288.2014.962108. Epub 2014 Sep 22.
Results Reference
result
PubMed Identifier
16690671
Citation
Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.
Results Reference
result
PubMed Identifier
32311034
Citation
Wosik J, Fudim M, Cameron B, Gellad ZF, Cho A, Phinney D, Curtis S, Roman M, Poon EG, Ferranti J, Katz JN, Tcheng J. Telehealth transformation: COVID-19 and the rise of virtual care. J Am Med Inform Assoc. 2020 Jun 1;27(6):957-962. doi: 10.1093/jamia/ocaa067.
Results Reference
result
PubMed Identifier
29037637
Citation
Yonglitthipagon P, Muansiangsai S, Wongkhumngern W, Donpunha W, Chanavirut R, Siritaratiwat W, Mato L, Eungpinichpong W, Janyacharoen T. Effect of yoga on the menstrual pain, physical fitness, and quality of life of young women with primary dysmenorrhea. J Bodyw Mov Ther. 2017 Oct;21(4):840-846. doi: 10.1016/j.jbmt.2017.01.014. Epub 2017 Feb 7.
Results Reference
result
PubMed Identifier
9817107
Citation
Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol. 1998 Nov;51(11):903-12. doi: 10.1016/s0895-4356(98)00081-x.
Results Reference
result
Links:
URL
http://icd.who.int/browse10/2016/en
Description
International Statistical Classification of Diseases and Related Health Problems 10th Revision
URL
http://bpsmedicine.biomedcentral.com/articles/10.1186/s13030-019-0165-0
Description
Effects of reflexology on premenstrual syndrome: a systematic review and meta-analysis
URL
http://www.who.int/emergencies/diseases/novel-coronavirus-2019
Description
Coronavirus disease (COVID-19) pandemic/Vaccines, treatment & tests
URL
http://publichealthmatters.blog.gov.uk/
Description
Public health matters

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Investigation of the Effect of Online Yoga Based Exercise Program on Women With Primary Dysmenorrhea

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