NCT06961396

Brief Summary

To investigate the effect of virtual reality on painful menstruation in adolescent female

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 7, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

April 8, 2025

Last Update Submit

April 28, 2025

Conditions

Painful MenstruationRelaxation; Back Ligaments

Keywords

virtual realityDiaphragmatic Releasing TechniquePainful MenstruationAdolescent Female

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    Measurement of pain intensity using a visual analogue scale via the application of a virtual reality device combined with diaphragmatic release exercises

    1o days for successive three months

Secondary Outcomes (1)

  • Menstrual Distress Questionnaire

    1o days for successive three months

Study Arms (2)

virtual reality combined with diaphragmatic breathing technique

EXPERIMENTAL

to investigate the effect of virtual reality combined with the diaphragmatic breathing technique on painful menstruation, applied for 10 days successive 3 months

Device: Relaxation TechniqueDevice: Pain treatment

cold LASER combined with diaphragmatic breathing technique

EXPERIMENTAL

to investigate the effect of cold LASER combined with diaphragmatic breathing technique on painful menstruation applied for 10 days successive 3 months

Device: Relaxation TechniqueDevice: Pain treatment

Interventions

Relaxation TechniqueDEVICE

utilizing virtual reality and a relaxation technique called diaphragmatic release to treat menstrual pain sufferers

Also known as: Pain management
cold LASER combined with diaphragmatic breathing techniquevirtual reality combined with diaphragmatic breathing technique
Pain treatmentDEVICE

utilizing cold laser and a relaxation technique called diaphragmatic release to treat menstrual pain sufferers

Also known as: Pain management
cold LASER combined with diaphragmatic breathing techniquevirtual reality combined with diaphragmatic breathing technique

Eligibility Criteria

Age13 Years - 20 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsundergraduate students
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age from 16 to 22 year
  • cases of primary dysmenorrhea
  • Normal body mass index (20-25)

You may not qualify if:

  • cases with polycystic ovarian syndrome
  • Obese female or body mass index more than 25
  • severe bleeding with menstruation
  • cases with low back pain due to orthopedic origin like disc herniation or spinal malalignment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mohamed Abdel Moenem Abo El Ros

Ismailia, 8332601, Egypt

RECRUITING

Zaytona University in Jordon

Amman, Jordan

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Relaxation TherapyPain ManagementAnalgesia

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesDisease ManagementPatient Care ManagementHealth Services AdministrationAnesthesia and Analgesia

Study Officials

  • Hadeel MA Badwan, Ph.D

    Al Zaytona University in Jordon

    STUDY CHAIR

Central Study Contacts

Mohamed AM Abo El Ros, Ph.D

CONTACT

01206530584mohamed.aboelros@pt.ninu.edu.eg

Kerolous IS Kelini, Ph.D

CONTACT

012297121263530@zuj.edu.jo

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Using Sealed Envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatric Physical Therapy

Study Record Dates

First Submitted

April 8, 2025

First Posted

May 7, 2025

Study Start

April 1, 2025

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

May 7, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

online sharing

Locations

JO(1)EG(1)