Clinical trial NCT05285475: Functional Exercises With Water Intake in Primary Dysmenorrhea
Official title: Effect of Functional Exercises With Water Intake on Sleep Quality and Menstrual Symptoms in Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Functional exercises, water intake, Menstrual Pain, Sleep
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 34
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two parallel groups in the study.
Primary purpose: TREATMENT

Brief summary: Dysmenorrhea and its associated symptoms are very common in women. In Pakistan, almost 78% of women report Primary Dysmenorrhea. This will be a randomized controlled trial with two parallel groups. one group will be receiving functional exercises along with water intake and the other will be receiving no interventions.

Detailed description: Mostly in the reproductive years of age women suffers from the Pain of Menstruation which is known as Dysmenorrhea. In Pakistan every other girl is silently suffers from this disease leading to the inefficiency and one of the main cause of school and work absenteeism. This novel study is designed to target the menstrual symptoms of women with functional exercises combine with optimal intake of water. The objective of this study is to determine the effects of functional exercises with water intake on menstrual symptoms and pain in Primary Dysmenorrhea.

This is a Randomized controlled study. Before the study, all the participants will go through baseline evaluation, and then allocated to the groups. The exercise protocol consisting of the combination of exercises with regular intake of water (in bouts) will be informed to them. Females fulfilling the criteria and willing to participate in exercise trial will be recruited in the study. Outcome will be assessed at baseline and post treatment after 8th week.

Eligibility criteria: Inclusion Criteria:

* Age group 15-35
* Patients with pain at a severity level of 5 on NPRS during menstruation.
* Primary Dysmenorrhea diagnosis made on WALIDD score
* Patients having regular menstrual cycle

Exclusion Criteria:

* Patients having some previous surgical history
* Patients diagnosed with Secondary Dysmenorrhea
* Abnormal Cognition
* Involved in any regular physical activity for last 6 months

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: changes from Baseline to 8th week
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Post 8 weeks
measure: Menstrual Symptom Questionnaire (MSQ)
timeFrame: changes from Baseline to 8th week
measure: Menstrual Symptom Questionnaire (MSQ)
timeFrame: post 8th week
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: changes from Baseline to 8th week
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: post 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Behbud Association of Pakistan
state: Fedral
Study officials:
affiliation: Riphah International University
name: Huma Riaz, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirmizigil B, Demiralp C. Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial. Arch Gynecol Obstet. 2020 Jul;302(1):153-163. doi: 10.1007/s00404-020-05579-2. Epub 2020 May 15.
citation: Mahvash N, Eidy A, Mehdi K, Zahra MT, Mani M, Shahla H. The effect of physical activity on primary dysmenorrhea of female university students. World Applied Sciences Journal. 2012;17(10):1246-52.
citation: Ortiz MI, Cortes-Marquez SK, Romero-Quezada LC, Murguia-Canovas G, Jaramillo-Diaz AP. Effect of a physiotherapy program in women with primary dysmenorrhea. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:24-9. doi: 10.1016/j.ejogrb.2015.08.008. Epub 2015 Aug 17.
citation: Rakhshaee Z. Effect of three yoga poses (cobra, cat and fish poses) in women with primary dysmenorrhea: a randomized clinical trial. J Pediatr Adolesc Gynecol. 2011 Aug;24(4):192-6. doi: 10.1016/j.jpag.2011.01.059. Epub 2011 Apr 21.