Functional Exercises With Water Intake in Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

Effect of Functional Exercises With Water Intake on Sleep Quality and Menstrual Symptoms in Primary Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05285475
• Other study ID #: 024433
• Status: Completed
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: July 7, 2022

Study information

• Verified date: July 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 7, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Other:
• Exercise and Water Intake
The exercise protocol for this group will be abdominals, pelvic stretching and kegels exercises (PFM) for three days/week lasting about 30 minutes with approximately 1600-1800ml (8-10 glasses) intake of water for 8 weeks (two consecutive menstrual cycles) Exercises include: Piriformis stretching (5 repetitions×20 seconds) Adductor stretching (5 repetitions×20 seconds) Sit-ups (10 repetitions×3 sets) Bridging (10 repetitions×3 sets) Kegels exercises (10 repetions×3 sets) Pelvic elevation (10 repetitions×3 sets) Pelvic rotation (10 repetitions×3 sets) Cobra pose (5 repetitions×20 seconds)

Locations

Country	Name	City	State
Pakistan	Behbud Association of Pakistan	Rawalpindi	Fedral

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View 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.

Ortiz MI, Cortés-Márquez SK, Romero-Quezada LC, Murguía-Cánovas G, Jaramillo-Díaz 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale (NPRS)	The Numeric Pain Rating Scale (NPRS) (an outcome measure) is a one-dimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme (or "worst pain imaginable"). The intrarater reliability with ICC = 0.67.	changes from Baseline to 8th week
Primary	Numeric Pain Rating Scale (NPRS)	The Numeric Pain Rating Scale (NPRS) (an outcome measure) is a one-dimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme (or "worst pain imaginable"). The intrarater reliability with ICC = 0.67.	Post 8 weeks
Primary	Menstrual Symptom Questionnaire (MSQ)	The menstrual symptom questionnaire is a Psychometric test used to determine the menstrual symptoms. The questionnaire consists of 24 items	changes from Baseline to 8th week
Primary	Menstrual Symptom Questionnaire (MSQ)	The menstrual symptom questionnaire is a Psychometric test used to determine the menstrual symptoms. The questionnaire consists of 24 items	post 8th week
Primary	Pittsburgh Sleep Quality Index (PSQI)	The Pittsburg Sleep Quality Index (PSQI) is used to evaluate sleep quality with score ranging from 0 to 21. Higher scores indicate poor sleep quality	changes from Baseline to 8th week
Primary	Pittsburgh Sleep Quality Index (PSQI)	The Pittsburg Sleep Quality Index (PSQI) is used to evaluate sleep quality with score ranging from 0 to 21. Higher scores indicate poor sleep quality	post 8th week