EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME
Primary Purpose
Premenstrual Tension
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dietary supplement ,electronic treadmill ,DASH diet.
Sponsored by
About this trial
This is an interventional treatment trial for Premenstrual Tension
Eligibility Criteria
Inclusion Criteria:
- Fifty adolescent females were diagnosed with premenstrual syndrome.
- Their age will be ranged from 15-to 25 years (3 years post-puberty).
- Their body mass index (BMI) will range from 18-25.9 kg/m2.
- All are of regular menstrual cycles.
- All of them suffer from moderate and severe PMS.
Exclusion Criteria:
- Any pathologic findings in the pelvic cavity as a polycystic ovarian syndrome, endometriosis, and pelvic inflammatory diseases.
- Having irregular menstruation.
- Any metabolic diseases.
- Any history of gynecological intervention.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
medical treatment
the same medication, in addition to DASH diet and aerobic exercise
Arm Description
Control group:Will be consisted of 25 females suffering from PMS will receive medical treatment in form of vit, B6, ca supplements and minerals (vitatron), once daily(1capsule), for 12 weeks.
Study group: Will be consisted of 25 females suffering from PMS will Receive the same medication as in group (A) in addition to the DASH diet and aerobic exercise for 30 minutes,3 times/week,for 12 weeks.
Outcomes
Primary Outcome Measures
Visual analogue scale (VAS)
Visual analogue scale (VAS):
Degrees of menstrual pain will be assessed using a VAS for all participants in both groups (A&B) before and after treatment, which is a method of representing .participants pain on a 10 cm linear scale. A score of zero mean "a very low degree of pain" and 10 mean "a very high degree of pain"
Menstrual Distress Questionnaire (MDQ)
Menstrual Distress Questionnaire (MDQ):
The subjects decreased activity, lower back pain, tension or anxiety, breast tenderness, and headaches will assess for all participants in both group before and after treatment using Menstrual Distress Questionnaire (MDQ) .Each item will be score on a 5-point likert scale ,with 1 being "no pain at all" follow by "mild pain", "moderate pain", "slightly sever pain" ,and "extremely severe pain.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05395169
Brief Title
EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME
Official Title
EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypothesis:
There will be no effect of the DASH diet and aerobic exercise on premenstrual syndrome.
Statement of the problem:
Do the DASH diet and aerobic exercise have an effect on premenstrual syndrome?
Detailed Description
For some women, symptoms of PMS may be so severe that they miss work or school. Physical activity is a suitable method for the treatment of PMS and is the best method for all women to reduce pressure and balance the brain's chemical secretion. It seems that physical activity by increasing endorphins and reducing adrenal cortisol leads to the improvement of symptoms of PMS.
DASH diet has been suggested to play an important role in the development, and treatment of some psychological disorders. For instance, it has been reported that a diet rich in fish, folate, and B-vitamins can alleviate the manifestations of depression. An established association was also shown between the dietary glycemic index (GI) and psychological diseases, depressive disorder, and mental functioning.
Diets containing of "junk foods" (high energy and low nutritional) have been shown to increase the risk of mental illness, but a healthy diet is associated with less depressive symptoms and can improve mood .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Tension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
medical treatment
Arm Type
Experimental
Arm Description
Control group:Will be consisted of 25 females suffering from PMS will receive medical treatment in form of vit, B6, ca supplements and minerals (vitatron), once daily(1capsule), for 12 weeks.
Arm Title
the same medication, in addition to DASH diet and aerobic exercise
Arm Type
Experimental
Arm Description
Study group: Will be consisted of 25 females suffering from PMS will Receive the same medication as in group (A) in addition to the DASH diet and aerobic exercise for 30 minutes,3 times/week,for 12 weeks.
Intervention Type
Other
Intervention Name(s)
dietary supplement ,electronic treadmill ,DASH diet.
Intervention Description
Control group Will be receive medical treatment for 12 weeks. Study group Will be receive the same medication as in control group in addition to DASH diet and aerobic exercise for 12 weeks.
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
Visual analogue scale (VAS):
Degrees of menstrual pain will be assessed using a VAS for all participants in both groups (A&B) before and after treatment, which is a method of representing .participants pain on a 10 cm linear scale. A score of zero mean "a very low degree of pain" and 10 mean "a very high degree of pain"
Time Frame
assessment will be take 12 weeks
Title
Menstrual Distress Questionnaire (MDQ)
Description
Menstrual Distress Questionnaire (MDQ):
The subjects decreased activity, lower back pain, tension or anxiety, breast tenderness, and headaches will assess for all participants in both group before and after treatment using Menstrual Distress Questionnaire (MDQ) .Each item will be score on a 5-point likert scale ,with 1 being "no pain at all" follow by "mild pain", "moderate pain", "slightly sever pain" ,and "extremely severe pain.
Time Frame
assessment will be take 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fifty adolescent females were diagnosed with premenstrual syndrome.
Their age will be ranged from 15-to 25 years (3 years post-puberty).
Their body mass index (BMI) will range from 18-25.9 kg/m2.
All are of regular menstrual cycles.
All of them suffer from moderate and severe PMS.
Exclusion Criteria:
Any pathologic findings in the pelvic cavity as a polycystic ovarian syndrome, endometriosis, and pelvic inflammatory diseases.
Having irregular menstruation.
Any metabolic diseases.
Any history of gynecological intervention.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Azaa Barmoud, professor
Phone
01008410312
Email
drazzakassab@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME
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