Effect of Mojzisova Method on Pain, Menstrual Symptom and Insomnia in PD

Primary Dysmenorrhea Clinical Trial

Official title:

Effect of Mojzisova Method on Pain, Menstrual Symptom and Insomnia in Primary Dysmenorrhea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06460870
• Other study ID #: REC/0562 Zainab Waheed
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Imran Amjad, Phd
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 30 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• Mojzisova method
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 exercises
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.

Locations

Country	Name	City	State
Pakistan	DHQ Hospital	Toba Tek Singh	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

Al-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. — View Citation

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. — View Citation

Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096. — View Citation

Itani 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. — View Citation

Iwata 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. — View Citation

Kannan 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. — View Citation

Kramp 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. — View Citation

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

Samy 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. — View Citation

Wu 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4th week
Primary	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.	4th week
Primary	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.	4th week