Painful MenstruationVRNCT06961396
Impact of Virtual Reality on Painful Menstruation
A study testing Relaxation Technique and Pain treatment in people with Painful Menstruation and Relaxation; Back Ligaments, run by New Ismailia National University at 2 sites in 2 countries.
Trial summary
To investigate the effect of virtual reality on painful menstruation in adolescent female Read more about this study
- Who is it for?
- Ages 13 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Painful Menstruation, Relaxation; Back Ligaments
- What is being tested?
- Relaxation Technique and Pain treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Apr 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age from 16 to 22 year
- cases of primary dysmenorrhea
- Normal body mass index (20-25)
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Egypt1 site, 1 recruiting
- Recruiting
Mohamed Abdel Moenem Abo El Ros
Ismailia, 8332601
Mohamed AM Abo El Ros, mohamed.aboelros@pt.ninu.edu.eg
mohamed.aboelros@pt.ninu.edu.eg
Jordan1 site, 1 recruiting
- Recruiting
Zaytona University in Jordon
Amman
Mohamed M Abo-El-Ros, Ph.D, 00960781524278 ext. A, 3767@zuj.edu.jo
Kerolous I Kelini, Ph.D, 00201229712126 ext. S, 3530@zuj.edu.jo
About this study
Official title: Impact of Virtual Reality Combined With Manual Diaphragmatic Release on Adolescent Female With Painful Menstruation
To investigate the effect of virtual reality on painful menstruation in adolescent female
Read the detailed description
The focus of relatively recent work has been on non-pharmacological pain management techniques. The usage of virtual reality (VR) devices that can replicate three-dimensional (3D) immersive worlds is one particularly exciting advancement. This technology is becoming more widely available in healthcare settings and has shown promise in lowering pain and anxiety levels for people receiving minor gynecological disorders, dental work, burn wound care, and labor. So, the research purpose is targeted to look into the impact of virtual reality combined with diaphragmatic release as an active relaxation technique on painful menstruation in adolescent female
- Conditions
- Painful Menstruation, Relaxation; Back Ligaments
- Being tested
- Relaxation Technique, Pain treatment
- Keywords
- virtual reality, Diaphragmatic Releasing Technique, Painful Menstruation, Adolescent Female
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation TechniqueDevice
Also called Pain management
utilizing virtual reality and a relaxation technique called diaphragmatic release to treat menstrual pain sufferers
Pain treatmentDevice
Also called Pain management
utilizing cold laser and a relaxation technique called diaphragmatic release to treat menstrual pain sufferers
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Relaxation Technique; Device: 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 Receives: Device: Relaxation Technique; Device: Pain treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
Measurement of pain intensity using a visual analogue scale via the application of a virtual reality device combined with diaphragmatic release exercises
Measured: 1o days for successive three months
Secondary outcomes (1)
Menstrual Distress Questionnaire
detects the type and severity and type of symptoms of different changes even it is physical, , behavioral mood changes, and arousal symptoms during the different phases of the menstrual cycle
Measured: 1o days for successive three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Apr 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful MenstruationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Ismailia National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel Moeim Abo EL Ros, New Ismailia National University
- Investigators
- Hadeel MA Badwan, Ph.D, Study chair, Al Zaytona University in Jordon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961396
- Sponsor's protocol ID
- IRB # 21/3/20242025
- Other IDs
- IRB # 21/3/20242025
- Acronym
- VR
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: online sharing
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Virtual Reality Combined With Manual Diaphragmatic Release on Adolescent Female With Painful Menstruation
- ClinicalTrials.gov ID
- NCT06961396
- Acronym / sponsor ID
- VR / IRB # 21/3/20242025
- Conditions
- Painful Menstruation, Relaxation; Back Ligaments
- Keywords
- virtual reality, Diaphragmatic Releasing Technique, Painful Menstruation, Adolescent Female
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- New Ismailia National UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of virtual reality on painful menstruation in adolescent female
Detailed description
The focus of relatively recent work has been on non-pharmacological pain management techniques. The usage of virtual reality (VR) devices that can replicate three-dimensional (3D) immersive worlds is one particularly exciting advancement. This technology is becoming more widely available in healthcare settings and has shown promise in lowering pain and anxiety levels for people receiving minor gynecological disorders, dental work, burn wound care, and labor. So, the research purpose is targeted to look into the impact of virtual reality combined with diaphragmatic release as an active relaxation technique on painful menstruation in adolescent female
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| virtual reality combined with diaphragmatic breathing technique | Experimental | Device: Relaxation Technique, Device: Pain treatmentto investigate the effect of virtual reality combined with the diaphragmatic breathing technique on painful menstruation, applied for 10 days successive 3 months |
| cold LASER combined with diaphragmatic breathing technique | Experimental | Device: Relaxation Technique, Device: Pain treatmentto investigate the effect of cold LASER combined with diaphragmatic breathing technique on painful menstruation applied for 10 days successive 3 months |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age from 16 to 22 year
- cases of primary dysmenorrhea
- Normal body mass index (20-25)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation TechniqueAlso: Pain managementutilizing virtual reality and a relaxation technique called diaphragmatic release to treat menstrual pain sufferers | Device | cold LASER combined with diaphragmatic breathing technique, virtual reality combined with diaphragmatic breathing technique |
| Pain treatmentAlso: Pain managementutilizing cold laser and a relaxation technique called diaphragmatic release to treat menstrual pain sufferers | Device | cold LASER combined with diaphragmatic breathing technique, virtual reality combined with diaphragmatic breathing technique |
Primary outcome
pain intensity
Time frame: 1o days for successive three months
Measurement of pain intensity using a visual analogue scale via the application of a virtual reality device combined with diaphragmatic release exercises
1 secondary outcome
Menstrual Distress Questionnaire
Time frame: 1o days for successive three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No. online sharing
Related trials for Painful Menstruation
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Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
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Painful Menstruation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hadeel MA Badwan, Ph.D study chair
Al Zaytona University in Jordon
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Technique and Pain treatment in people with Painful Menstruation and Relaxation; Back Ligaments, run by New Ismailia National University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt, Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed AM Abo El Ros, Ph.D (01206530584, mohamed.aboelros@pt.ninu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: 1o days for successive three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.