Primary DysmenorrheaNCT06460870
Effect of Mojzisova Method on Pain, Menstrual Symptom and Insomnia in PD
A study testing Mojzisova method and Stretching exercises in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
Trial summary
This project was a Randomized controlled trial conducted to check the effectiveness of mojzisova method in primary dysmenorrhea for pain, menstrual symptoms and insomnia. Duration was of 6 months, convenient sampling was done, subject following eligibility criteria from DHQ hospital Toba Tek were randomly assigned… Read more about this study
- Who is it for?
- Ages 15 to 30 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Mojzisova method and Stretching exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2024to 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 15 to 30 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pain must be recurrent (at least following three menstrual cycles).
- No history of any blood problems, such as thalassemia, folate insufficiency, or anemia due to a lack of iron. Five criteria to fulfill to be considered primary dysmenorrhea.
- Hypogastrium pain during menstruation.
- Irradiation of pain to lower back, lower limbs or lingual region.
- Inability to perform daily activity.
- The need for medical management or self-medication to control pain Nulliparous women with primary dysmenorrhea.
Who cannot join
- Female with history of any specific disease.
- Female with endocrine disorders.
- Had gone major surgery.
- Diagnosis of secondary dysmenorrhea.
- Having symptoms such as numbness and tingling sensation.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
DHQ Hospital
Toba Tek Singh, Punjab Province, 36050
H Neelam Muneeb, 03204097476, hafiza.neelam@riphah.edu.pk
Zainab Waheed, MS-WHPT
About this study
Official title: Effect of Mojzisova Method on Pain, Menstrual Symptom and Insomnia in Primary Dysmenorrhea
This project was a Randomized controlled trial conducted to check the effectiveness of mojzisova method in primary dysmenorrhea for pain, menstrual symptoms and insomnia. Duration was of 6 months, convenient sampling was done, subject following eligibility criteria from DHQ hospital Toba Tek were randomly assigned, baseline assessment was done, Group A paarticipants were given baseline treatment along with mojzisova method, Group B participants were given baseline treatment along with stretching exercises, post intervention assessment was done, via WALIDD, Numeric pain rating scale (NPRS) and Pittsburgh sleep quality index (PSQI) questionnaire 45 minutes per session, 2 sessions per month for 3 months, data was analyzed by using SPSS version 26.
Read the detailed description
Primary dysmenorrhea is most common reported problems to gynecologists and physical therapists. There is long history of using over the counter painkillers. Due to this there is high absenteeism from schools colleges and work. On the basis of symptoms primary dysmnorhea can be separated from secondary dysmenorrhea.Physical activity has long been used for relieving the pain, menstrual symptoms and improve insomnia. Previous studies also reported the effects of stretching exercises, core stabilizing exercises yoga, Pilates, aerobics on improving the pain and symptoms in primary dysmenorrhea. According to researcher knowledge there is limited evidence on mojzisova method that how this method improve the menstrual symptoms, pain and insomnia in primary dysmenorrhea. The aim of this study is to see the effects of mojzisova method on pain, menstrual symptom and insomnia in primary dysmenorrhea.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Mojzisova method, Stretching exercises
- Keywords
- insomnia, menstrual symptom, pain, primary dysmenorrhea, stretching
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mojzisova methodOther
The home based regular exercises stretching and strengthning exercises twice daily along with hot pack. Manual therapy was applied in the first half of the menstrual cycle, once a month, for one hour. It includes mobilization of ribs, lumbar spine, and sacroiliac joints as well as coccygeal treatment, and internal rectal work. The patient was received 2 sessions per month for 3 months, for 45 minutes.
Stretching exercisesOther
Stretching exercises was performed such as cobra pose, cat/cow pose and baby pose along with hotpack for 2 sessions per month for 45 min for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Mojzisova method | Experimental | Mobilization of rib, lumbar spine, SI joint and internal rectal work. Stretching and strengthening exercises of pelvic floor, lumbar spine, sacrum and coccyx. Receives: Other: Mojzisova method |
| Stretching exercises | Active comparator | Stretching exercises cobra pose, child pose and cat/cow pose. Receives: Other: Stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
WALIDD
A scale-type survey (working ability, location, intensity, days of pain, dysmenorrhea [WaLIDD] score) was designed.)which integrated features of dysmenorrhea such as: 1) number of anatomical pain locations (no part of the body, lower abdomen, lumbar region, lower limbs, inguinal region), 2) Wong-Baker pain range (does not hurt, hurts a little, hurts a little more, hurts even more, hurts a lot, hurts a lot more), 3) number of days of pain during menstruation (0, 1-2, 3-4, ≥5), and 4) frequency of disabling pain to perform their activities (never, almost never, almost always, always).Each tool's variable provided a specific score between 0 and 3, and the final score ranged from 0 to 12 points.
Measured: 4th week
NPRS
The numeric rating scale is similar to the VAS in that it is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable" (or something similar). The difference is that instead of a line without marks, numbers from 0 to 10 are spaced evenly across the page. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. A variation of this scale is the verbal numeric scale (VNS), in which patients are asked to verbally state a number between 0 and 10 that corresponds to their present pain intensity.
Measured: 4th week
PSQI Questionnaire
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Seven component scores, ranging from 0 (no difficulty) to 3 (extreme difficulty), are obtained while assessing the PSQI. The global score, which ranges from 0 to 21, is calculated by adding the component scores. Poorer sleep quality is indicated by higher scores.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakeel Ur Rehman, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460870
- Sponsor's protocol ID
- REC/0562 Zainab Waheed
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alikamali M, Mohammad-Alizadeh-Charandabi S, Maghalian M, Mirghafourvand M. The effects of vitamin E on the intensity of primary dysmenorrhea: A systematic review and meta-analysis. Clin Nutr ESPEN. 2022 Dec;52:50-59. doi: 10.1016/j.clnesp.2022.10.001. Epub 2022 Oct 9.
PubMed 36513486Wu L, Zhang J, Tang J, Fang H. The relation between body mass index and primary dysmenorrhea: A systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2022 Dec;101(12):1364-1373. doi: 10.1111/aogs.14449. Epub 2022 Sep 20.
PubMed 36124820Itani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HMJ. Primary Dysmenorrhea: Pathophysiology, Diagnosis, and Treatment Updates. Korean J Fam Med. 2022 Mar;43(2):101-108. doi: 10.4082/kjfm.21.0103. Epub 2022 Mar 17.
PubMed 35320895Iwata M, Oikawa Y, Shimizu Y, Sakashita N, Shoji A, Igarashi A, Osuga Y. Efficacy of Low-Dose Estrogen-Progestins and Progestins in Japanese Women with Dysmenorrhea: A Systematic Review and Network Meta-analysis. Adv Ther. 2022 Nov;39(11):4892-4909. doi: 10.1007/s12325-022-02298-9. Epub 2022 Sep 1.
PubMed 36048405Al-Husban N, Odeh O, Dabit T, Masadeh A. The Influence of Lifestyle Variables on Primary Dysmenorrhea: A Cross-Sectional Study. Int J Womens Health. 2022 Apr 13;14:545-553. doi: 10.2147/IJWH.S338651. eCollection 2022.
PubMed 35444471Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.
PubMed 33030880McKenna KA, Fogleman CD. Dysmenorrhea. Am Fam Physician. 2021 Aug 1;104(2):164-170.
PubMed 34383437Kramp ME. Combined manual therapy techniques for the treatment of women with infertility: a case series. J Am Osteopath Assoc. 2012 Oct;112(10):680-4.
PubMed 23055467Kannan P, Chapple CM, Miller D, Claydon-Mueller L, Baxter GD. Effectiveness of a treadmill-based aerobic exercise intervention on pain, daily functioning, and quality of life in women with primary dysmenorrhea: A randomized controlled trial. Contemp Clin Trials. 2019 Jun;81:80-86. doi: 10.1016/j.cct.2019.05.004. Epub 2019 May 7.
PubMed 31071464Samy A, Zaki SS, Metwally AA, Mahmoud DSE, Elzahaby IM, Amin AH, Eissa AI, Abbas AM, Hussein AH, Talaat B, Ali AS. The Effect of Zumba Exercise on Reducing Menstrual Pain in Young Women with Primary Dysmenorrhea: A Randomized Controlled Trial. J Pediatr Adolesc Gynecol. 2019 Oct;32(5):541-545. doi: 10.1016/j.jpag.2019.06.001. Epub 2019 Jun 11.
PubMed 31195099
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mojzisova Method on Pain, Menstrual Symptom and Insomnia in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06460870
- Acronym / sponsor ID
- REC/0562 Zainab Waheed
- Conditions
- Primary Dysmenorrhea
- Keywords
- insomnia, menstrual symptom, pain, primary dysmenorrhea, stretching
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project was a Randomized controlled trial conducted to check the effectiveness of mojzisova method in primary dysmenorrhea for pain, menstrual symptoms and insomnia. Duration was of 6 months, convenient sampling was done, subject following eligibility criteria from DHQ hospital Toba Tek were randomly assigned, baseline assessment was done, Group A paarticipants were given baseline treatment along with mojzisova method, Group B participants were given baseline treatment along with stretching exercises, post intervention assessment was done, via WALIDD, Numeric pain rating scale (NPRS) and Pittsburgh sleep quality index (PSQI) questionnaire 45 minutes per session, 2 sessions per month for 3 months, data was analyzed by using SPSS version 26.
Detailed description
Primary dysmenorrhea is most common reported problems to gynecologists and physical therapists. There is long history of using over the counter painkillers. Due to this there is high absenteeism from schools colleges and work. On the basis of symptoms primary dysmnorhea can be separated from secondary dysmenorrhea.Physical activity has long been used for relieving the pain, menstrual symptoms and improve insomnia. Previous studies also reported the effects of stretching exercises, core stabilizing exercises yoga, Pilates, aerobics on improving the pain and symptoms in primary dysmenorrhea. According to researcher knowledge there is limited evidence on mojzisova method that how this method improve the menstrual symptoms, pain and insomnia in primary dysmenorrhea. The aim of this study is to see the effects of mojzisova method on pain, menstrual symptom and insomnia in primary dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mojzisova method | Experimental | Other: Mojzisova methodMobilization of rib, lumbar spine, SI joint and internal rectal work. Stretching and strengthening exercises of pelvic floor, lumbar spine, sacrum and coccyx. |
| Stretching exercises | Active comparator | Other: Stretching exercisesStretching exercises cobra pose, child pose and cat/cow pose. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Pain must be recurrent (at least following three menstrual cycles).
- No history of any blood problems, such as thalassemia, folate insufficiency, or anemia due to a lack of iron. Five criteria to fulfill to be considered primary dysmenorrhea.
- Hypogastrium pain during menstruation.
- Irradiation of pain to lower back, lower limbs or lingual region.
- Inability to perform daily activity.
Key exclusion criteria (5 listed)
- Female with history of any specific disease.
- Female with endocrine disorders.
- Had gone major surgery.
- Diagnosis of secondary dysmenorrhea.
- Having symptoms such as numbness and tingling sensation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mojzisova methodThe home based regular exercises stretching and strengthning exercises twice daily along with hot pack. Manual therapy was applied in the first half of the menstrual cycle, once a month, for one hour. It includes mobilization of ribs, lumbar spine, and sacroiliac joints as well as coccygeal treatment, and internal rectal work. The patient was received 2 sessions per month for 3 months, for 45 minutes. | Other | Mojzisova method |
| Stretching exercisesStretching exercises was performed such as cobra pose, cat/cow pose and baby pose along with hotpack for 2 sessions per month for 45 min for 3 months. | Other | Stretching exercises |
Primary outcome
WALIDD
Time frame: 4th week
A scale-type survey (working ability, location, intensity, days of pain, dysmenorrhea [WaLIDD] score) was designed.)which integrated features of dysmenorrhea such as: 1) number of anatomical pain locations (no part of the body, lower abdomen, lumbar region, lower limbs, inguinal region), 2) Wong-Baker pain range (does not hurt, hurts a little, hurts a little more, hurts even more, hurts a lot, hurts a lot more), 3) number of days of pain during menstruation (0, 1-2, 3-4, ≥5), and 4) frequency of disabling pain to perform their activities (never, almost never, almost always, always).Each tool's variable provided a specific score between 0 and 3, and the final score ranged from 0 to 12 points.
NPRS
Time frame: 4th week
The numeric rating scale is similar to the VAS in that it is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable" (or something similar). The difference is that instead of a line without marks, numbers from 0 to 10 are spaced evenly across the page. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. A variation of this scale is the verbal numeric scale (VNS), in which patients are asked to verbally state a number between 0 and 10 that corresponds to their present pain intensity.
PSQI Questionnaire
Time frame: 4th week
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Seven component scores, ranging from 0 (no difficulty) to 3 (extreme difficulty), are obtained while assessing the PSQI. The global score, which ranges from 0 to 21, is calculated by adding the component scores. Poorer sleep quality is indicated by higher scores.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 36513486Alikamali M, Mohammad-Alizadeh-Charandabi S, Maghalian M, Mirghafourvand M. The effects of vitamin E on the intensity of primary dysmenorrhea: A systematic review and meta-analysis. Clin Nutr ESPEN. 2022 Dec;52:50-59. doi: 10.1016/j.clnesp.2022.10.001. Epub 2022 Oct 9.
- Background: PubMed 36124820Wu L, Zhang J, Tang J, Fang H. The relation between body mass index and primary dysmenorrhea: A systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2022 Dec;101(12):1364-1373. doi: 10.1111/aogs.14449. Epub 2022 Sep 20.
- Background: PubMed 35320895Itani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HMJ. Primary Dysmenorrhea: Pathophysiology, Diagnosis, and Treatment Updates. Korean J Fam Med. 2022 Mar;43(2):101-108. doi: 10.4082/kjfm.21.0103. Epub 2022 Mar 17.
- Background: PubMed 36048405Iwata M, Oikawa Y, Shimizu Y, Sakashita N, Shoji A, Igarashi A, Osuga Y. Efficacy of Low-Dose Estrogen-Progestins and Progestins in Japanese Women with Dysmenorrhea: A Systematic Review and Network Meta-analysis. Adv Ther. 2022 Nov;39(11):4892-4909. doi: 10.1007/s12325-022-02298-9. Epub 2022 Sep 1.
- Background: PubMed 35444471Al-Husban N, Odeh O, Dabit T, Masadeh A. The Influence of Lifestyle Variables on Primary Dysmenorrhea: A Cross-Sectional Study. Int J Womens Health. 2022 Apr 13;14:545-553. doi: 10.2147/IJWH.S338651. eCollection 2022.
- Background: PubMed 33030880Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.
- Background: PubMed 34383437McKenna KA, Fogleman CD. Dysmenorrhea. Am Fam Physician. 2021 Aug 1;104(2):164-170.
- Background: PubMed 23055467Kramp ME. Combined manual therapy techniques for the treatment of women with infertility: a case series. J Am Osteopath Assoc. 2012 Oct;112(10):680-4.
- Background: PubMed 31071464Kannan P, Chapple CM, Miller D, Claydon-Mueller L, Baxter GD. Effectiveness of a treadmill-based aerobic exercise intervention on pain, daily functioning, and quality of life in women with primary dysmenorrhea: A randomized controlled trial. Contemp Clin Trials. 2019 Jun;81:80-86. doi: 10.1016/j.cct.2019.05.004. Epub 2019 May 7.
- Background: PubMed 31195099Samy A, Zaki SS, Metwally AA, Mahmoud DSE, Elzahaby IM, Amin AH, Eissa AI, Abbas AM, Hussein AH, Talaat B, Ali AS. The Effect of Zumba Exercise on Reducing Menstrual Pain in Young Women with Primary Dysmenorrhea: A Randomized Controlled Trial. J Pediatr Adolesc Gynecol. 2019 Oct;32(5):541-545. doi: 10.1016/j.jpag.2019.06.001. Epub 2019 Jun 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed Shakeel Ur Rehman, Phd principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mojzisova method and Stretching exercises in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WALIDD (time frame: 4th week). 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 NCT06460870, which also lists 10 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 14 Jun 2024.