New Management of PMS Anxiety

NCT ID: NCT07037667

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-22

Study Completion Date

2025-02-04

Brief Summary

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The goal of this clinical trial is to determine the effect of Pilates exercises in management of premenstrual anxiety in adult virgin females.The main question it aims to answer is :

Do Pilates exercises have an effect on premenstrual anxiety? Researcher will compare the effect of Pilates exercises to dietary recommendations as healthy snacks rich in magnesium and vitamin B-6 to see if Pilates exercises have an effect on premenstrual anxiety.

Participants will :

Do Pilates exercises two times per week for 12 weeks.

Detailed Description

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Conditions

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Premenstrual Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experimental group

This group will do Pilates exercises as single leg lift 10 rep and one leg circle 5 times in each direction for 15 minutes 2 times per week for 12 weeks and receives dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6.

Group Type ACTIVE_COMPARATOR

Pilates exercises

Intervention Type OTHER

Single leg lifts:The participant is in supine lying position with knees bent and feet parallel and hip-width apart. Head, neck and shoulders totally relaxed and arm extended and relaxed beside the body. Then the participant is asked to inhale first without moving her leg then exhale while bringing one leg up towards chest , drawing her pelvic floor and abdominals up and in like gently tightening a belt and maintaining 90 degrees angle at the knee and then put her leg down while inhaling. One leg circle:The participant is in supine lying position with one leg raised towards the ceiling and the other leg on the floor and both knees slightly bent.Then the participant is asked to inhale first without moving her leg and to make sure to use the abdominal muscles to try to maintain a neutral pelvis while doing the exercise then makes a small circle while exhaling and inhale when she completes the circle and reaches the starting position.

Dietary recommendations

Intervention Type OTHER

Dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6.

Control group

This group will receive dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6.

Group Type PLACEBO_COMPARATOR

Dietary recommendations

Intervention Type OTHER

Dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6.

Interventions

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Pilates exercises

Single leg lifts:The participant is in supine lying position with knees bent and feet parallel and hip-width apart. Head, neck and shoulders totally relaxed and arm extended and relaxed beside the body. Then the participant is asked to inhale first without moving her leg then exhale while bringing one leg up towards chest , drawing her pelvic floor and abdominals up and in like gently tightening a belt and maintaining 90 degrees angle at the knee and then put her leg down while inhaling. One leg circle:The participant is in supine lying position with one leg raised towards the ceiling and the other leg on the floor and both knees slightly bent.Then the participant is asked to inhale first without moving her leg and to make sure to use the abdominal muscles to try to maintain a neutral pelvis while doing the exercise then makes a small circle while exhaling and inhale when she completes the circle and reaches the starting position.

Intervention Type OTHER

Dietary recommendations

Dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All participants are virgins.
* All of them suffering from moderate and severe premenstrual anxiety.
* Their BMI is less than 30 km/m2
* The regularity of their menstrual cycle is 28-35 days.

Exclusion Criteria

* Smoking.
* Taking any medications for anxiety.
* Irregular menstruation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Summer Kamal Abbas Mabrouk

Master's degree student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Elbeheira governorate

Damanhūr, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P.T.REC/012/004060

Identifier Type: -

Identifier Source: org_study_id

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