Clinical Trial Radar

This clinical trial, identified as NCT06961396 and titled "Impact of Virtual Reality on Painful Menstruation" (VR), aims to explore how virtual reality (VR) technology, when combined with a relaxation technique, can affect painful menstruation in adolescent females.

📋 Trial Overview

The study investigates a non-pharmacological approach to managing painful menstruation, also known as dysmenorrhea. It compares the effectiveness of virtual reality combined with diaphragmatic release (a relaxation technique) against cold laser therapy combined with the same relaxation technique. The research is driven by the growing interest in using immersive technologies like VR for pain and anxiety reduction in various medical contexts.

🎯 Purpose

The primary purpose of this trial is to determine if using virtual reality alongside diaphragmatic release can effectively reduce the intensity of menstrual pain in adolescent females. A secondary goal is to assess the impact on overall menstrual distress, including physical, behavioral, and mood changes.

🔬 Terminology Explained

• Painful Menstruation (Primary Dysmenorrhea): This refers to cramping pain in the lower abdomen that occurs before or during menstruation, in the absence of other underlying pelvic diseases.
• Virtual Reality (VR): A technology that creates immersive, three-dimensional (3D) environments, allowing users to experience and interact with a simulated world. In this context, it's used as a tool for distraction and relaxation to manage pain.
• Diaphragmatic Release: A relaxation technique that involves deep, controlled breathing, focusing on the movement of the diaphragm. It's often used to promote relaxation and reduce stress or pain.
• Visual Analogue Scale (VAS): A common tool used to measure pain intensity. Participants typically mark their pain level on a continuous line, ranging from "no pain" to "worst imaginable pain."
• Menstrual Distress Questionnaire (MDQ): A questionnaire designed to assess the severity and types of symptoms experienced during different phases of the menstrual cycle, including physical symptoms, mood changes, behavioral changes, and arousal symptoms.
• Randomized Clinical Trial: A study design where participants are randomly assigned to different treatment groups. This helps to minimize bias and ensure that the groups are comparable.
• Single Masking (Single-Blind): In this study, the participants are "masked" or "blinded," meaning they do not know which treatment group they have been assigned to. This helps prevent their expectations from influencing the results. The investigators are aware of the treatment assignments.

🧪 Study Design

This is an interventional study with a randomized, parallel assignment design. This means participants will be randomly assigned to one of two groups, and each group will receive a different intervention simultaneously.

• Intervention Group 1: Will receive virtual reality combined with diaphragmatic breathing technique.
• Intervention Group 2: Will receive cold laser therapy combined with diaphragmatic breathing technique.

The study is single-masked, where only the participants are unaware of the specific intervention they are receiving. This is achieved using sealed envelopes for allocation. The primary purpose is treatment.

Notice: Check the Trial Radar Card View 'Study Plan' tab for more Arms & Interventions details.

✅ Participation & Eligibility

The trial plans to enroll 200 adolescent females.

Key Inclusion Criteria:

• Age from 16 to 22 years.
• Diagnosed with primary dysmenorrhea.
• Normal body mass index (BMI) between 20-25.

Key Exclusion Criteria:

• Polycystic ovarian syndrome (PCOS).
• Obesity (BMI more than 25).
• Severe menstrual bleeding.
• Low back pain due to orthopedic issues like disc herniation or spinal malalignment.

The study is recruiting healthy volunteers who are female undergraduate students. The specified age range for participation is 13 to 20 years, although the inclusion criteria state 16 to 22 years. This discrepancy might warrant clarification from the study coordinators.

Notice: Check the Trial Radar Card View 'Participation' tab for complete Eligibility details.

📊 Outcomes Measured / Endpoints

The study will assess the following:

Primary Outcome:

• Pain Intensity: Measured using a Visual Analogue Scale (VAS). This will be assessed over 10 days for three successive months, specifically looking at the impact of VR combined with diaphragmatic release.

Secondary Outcome:

• Menstrual Distress: Evaluated using the Menstrual Distress Questionnaire to detect the type and severity of various symptoms (physical, behavioral, mood, arousal) during different phases of the menstrual cycle. This will also be assessed over 10 days for three successive months.

Notice: Check the Trial Radar Card View 'Study Plan' tab for complete Outcome details.
Notice Outcome Stats: Total outcomes - Primary: 1, Secondary: 1, Other: 0

📈 Related Research & Trends

This study aligns with a growing trend in healthcare exploring non-pharmacological methods for pain management. Virtual reality, in particular, has shown promise in various medical procedures and conditions by distracting patients from pain and reducing anxiety. Its application for gynecological conditions like painful menstruation is an innovative area of research.

🌍 Locations

The trial is planned to be conducted at sites in Egypt and Jordan.

Notice: Check the Trial Radar Card View 'Contacts & Locations' tab for more Location details.

This trial is sponsored by New Ismailia National University and is currently in the "Recruiting" phase, with an anticipated start date of April 1, 2025, and an estimated completion date of January 1, 2026.

It's important for individuals considering participation in any clinical trial to discuss it thoroughly with their healthcare provider to understand the potential benefits and risks.

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