Functional Exercises With Water Intake in Primary Dysmenorrhea

NCT05285475 | Completed

• 1 other identifier: 024433
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

Functional exercises, water intake, Menstrual Pain, Sleep

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Group A

EXPERIMENTAL

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)

Other: Exercise and Water Intake

Group B

NO INTERVENTION

The participants in this group will be asked neither to do any exercise nor to change their daily basis routine.

Interventions

Exercise and Water Intake OTHER

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)

Group A

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Behbud Association of Pakistan

Rawalpindi, Fedral, 46000, Pakistan

Location

Related 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.

  PMID: 32415471 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26319652 BACKGROUND

• 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.

  PMID: 21514190 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Exercise; Drinking

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Eating; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Huma Riaz, PHD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be kept blind from the group allocation of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be two parallel groups in the study.

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 17, 2022
• Study Start: March 10, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 7, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)