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The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students

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ClinicalTrials.gov Identifier: NCT03821207
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Meryem Kurek eken, Aydin Adnan Menderes University

Brief Summary:
The study will planing to determine the advantages of abdominal massage and exercise on primary dysmenorrhea in university students, and to evaluate whether one of these applications is superior to the other.

Condition or disease Intervention/treatment Phase
Primary Dysmenorrhea Behavioral: The exercise group Behavioral: The abdominal massage group Behavioral: Control Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomised Controlled Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students: A Randomised Controlled Study
Actual Study Start Date : December 6, 2018
Actual Primary Completion Date : June 6, 2019
Actual Study Completion Date : July 2, 2019

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Arm Intervention/treatment
Active Comparator: The exercise group
The group will be instructed to perform stretching exercises including the pelvic and lumbar regions 3 times a day for the first 3 days of the menstrual cycle
Behavioral: The exercise group
The students will make exercise during the first three days of the menstrual period

Active Comparator: The abdominal massage group
The group will be instructed to massage the abdomen for 10 mins a day on the first 3 days of the menstrual cycle.The massage is to be applied as effleurage (light touch) clockwise over the abdomen
Behavioral: The abdominal massage group
The students will make abdominal massage during the first three days of the menstrual period

Placebo Comparator: The control group
The control group will perform no exercise or massage.
Behavioral: Control Group
The students will nor massage or exercise




Primary Outcome Measures :
  1. The primer outcome of the study was to investigate the effects of abdominal massage and exercise on the level of pain [ Time Frame: 6 month ]
    Visuale Analogue Scale will be used to measure pain level at 3 menstrual cycle. The change from baseline in Visual Analog Scale at 3 menstrual cycle will be measured in the studied groups

  2. The other primer outcome of the study was to investigate the effects of abdominal massage and exercise duration of pain. [ Time Frame: 6 month ]
    Dysmenorrhea Symptom List will be used to measure degree of dysmenorrhea symptoms at 3 menstrual cycle. The findings seen in the presence of dysmenorrhea in females during 3 menstrual cycle will be measured by decrease at severity of scores belong to Dysmenorrhea Symptom List.


Secondary Outcome Measures :
  1. The seconder outcome of the study was to investigate the effects of abdominal massage and exercise amount of menstruel bleeding [ Time Frame: 6 month ]
    Pictorial Blood Loss Evaluation Table will be used to measure the amount of menstrual bleeding. The amount of menstrual bleeding will be measured by change from baseline in the pictorial index score at 3 menstrual cycle



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Ages Eligible for Study:   18 Years to 20 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Regular menstrual cycles Record ≥ 6 points on VAS in the first 3 days of at least 2 of the last 3 menstrual cycles Not use analgesics during the study period

Exclusion Criteria:

Endometriosis Pelvic inflammatory disease Ovarian cyst Myoma Chronic pelvic pain Urinary system infection Menometrorrhagia Obstructive vaginal or uterine congenital anomalies Secondary dysmenorrhea A history of major abdominal or pelvic surgery in the last 3 months Hormonal treatment in the last 6 months.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821207


Locations
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Turkey
Meryem Kurek Eken
Aydın, Turkey, 09013
Sponsors and Collaborators
Aydin Adnan Menderes University
Investigators
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Study Director: Meryem Kurek Eken Aydin Adnan Menderes University
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Responsible Party: Meryem Kurek eken, Associated Proffesor, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT03821207    
Other Study ID Numbers: 2018/1357
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meryem Kurek eken, Aydin Adnan Menderes University:
Abdominal massage
Exercise
Primary Dysmenorrhea
Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms