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

NCT06460870 | Not Yet Recruiting

• 1 other identifier: REC/0562 Zainab Waheed
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Dysmenorrhea

Keywords

insomnia; menstrual symptom; pain; primary dysmenorrhea; stretching

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

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.

Other: Mojzisova method

Stretching exercises

ACTIVE COMPARATOR

Stretching exercises cobra pose, child pose and cat/cow pose.

Other: Stretching exercises

Interventions

Mojzisova method OTHER

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.

Mojzisova method

Stretching exercises OTHER

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.

Stretching exercises

Eligibility Criteria

• Age: 15 Years - 30 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

DHQ Hospital

Toba Tek Singh, Punjab Province, 36050, Pakistan

Location

Related Publications (10)

• 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.

  PMID: 36513486 BACKGROUND

• 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.

  PMID: 36124820 BACKGROUND

• 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.

  PMID: 35320895 BACKGROUND

• 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.

  PMID: 36048405 BACKGROUND

• 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.

  PMID: 35444471 BACKGROUND

• 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.

  PMID: 33030880 BACKGROUND

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

  PMID: 34383437 BACKGROUND

• 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.

  PMID: 23055467 BACKGROUND

• 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.

  PMID: 31071464 BACKGROUND

• 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.

  PMID: 31195099 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Pain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Syed Shakeel Ur Rehman, Phd

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Imran Amjad, Phd

CONTACT

051-5481826; imran.amjad@riphah.edu.pk

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

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)