Effect of Connective Tissue Massage on Premenstrual Syndrome

NCT06621680 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005312
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to investigate the effect of connective tissue massage on premenstrual syndrome.

Conditions

Premenstrual Syndrome

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Degrees of menstrual pain will be assessed using a VAS for all participants before and after treatment, which is a method of representing pain on a 10 cm linear scale. A score of zero means "No pain" and 10 means "a very high degree of pain".

  3 months

• Premenstrual syndrome severity

  Severity of premenstrual symptoms will be assessed by using the Menstrual Distress Questionnaire (MDQ). Each participant will examine symptom categories (pain, concentration, water retention, behavior changes, negative effect, autonomic reaction, arousal and control) Participants are asked to report the symptoms experienced during their most recent menstrual period, using a rating scale. Responses ranged from (0) No experience of the symptom, (1) mild, (2) moderate, (3) severe and (4) very severe disabling symptoms. Overall scores are interpreted as follows: \>50- mild, 50 to 70- moderate and \>70 severe

  3 months

Study Arms (2)

Multivitamins group

ACTIVE COMPARATOR

This group will receive multivitamins capsule once daily, for 12 weeks.

Drug: Multivitamins

Connective tissue massage group

EXPERIMENTAL

This group will receive multivitamins in addition to connective tissue massage on (Sacral, lumbar, last thoracic vertebrae-T12, and subcostal regions), 2 sessions/week, 20 minutes/ session for 12 weeks

Drug: Multivitamins; Other: Connective tissue massage

Interventions

Multivitamins DRUG

All participants will receive multivitamins (vitatron) capsule once daily, for 12 weeks.

Connective tissue massage group; Multivitamins group

Connective tissue massage OTHER

Connective tissue massage will be applied on (Sacral, lumbar, last thoracic vertebrae-T12, and subcostal regions), 2 sessions/week for 20 minutes each session for 12 weeks. Treatment will begin 3 days before menstruation to the 4th day of menstruation for 3 successive menstrual cycles.

Connective tissue massage group

Eligibility Criteria

• Age: 17 Years - 25 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Virgin adolescent females diagnosed with premenstrual syndrome.
• Their age will be ranged from 17-25 years (3 years post puberty).
• Their body mass index (BMI) will be less than 30 kg/m2 .
• All are of regular menstrual cycles.
• All of them suffering from moderate and severe PMS.

You may not qualify if:

• Participants will be excluded from this study if they have
• Any pathological finding in the pelvic cavity as polycystic ovarian syndrome, endometriosis, and pelvic inflammatory diseases.
• Irregular menstruation.
• Any history of gynecological intervention.
• Open wounds, weak/broken bones or fractures.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Enas Nabil Georgy

Giza, Egypt

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Geritol

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Azza B Kassab, professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Enas N Georgy, Master

CONTACT

+201222764419; nosa.mannous@gmail.com

Mohamed F Abo Eleinien, professor

CONTACT

+201001414404; drmohamedfawzy61@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 1, 2024
• Study Start: October 10, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 15, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)