Clinical trial NCT06728306: Virtual Reality-Based Relaxation and Exergaming vs. Traditional Relaxation for Primer Dysmenorrhea
Official title: Acute Impact of Virtual Reality-Based Relaxation and Exergaming Compared to Traditional Relaxation on Primary Dysmenorrhea Symptoms: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Exercise Therapy
Pain Management
Primary Dysmenorrhea
Progressive Muscle Relaxation
Virtual Reality
Lead sponsor: Trakya University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-12-11
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to investigate the acute effects of virtual reality-based relaxation (immersive VR relaxation) and exergaming (non-immersive VR) compared to traditional Jacobson's relaxation on symptoms of primary dysmenorrhea (PD) in women aged 18-30 years with regular menstrual cycles. The main questions it aims to answer are:

Does immersive VR relaxation reduce abdomino-pelvic pain and menstrual symptom severity more effectively than Jacobson's relaxation? Does non-immersive VR exergaming provide better pain relief and symptom management compared to traditional relaxation methods?

Hypotheses:

Immersive VR relaxation will result in significantly greater reductions in abdomino-pelvic pain and menstrual symptom severity compared to traditional relaxation.

Non-immersive VR exergaming will also provide better outcomes in pain and symptom management compared to traditional relaxation.

Researchers will compare immersive VR relaxation, non-immersive VR exergaming, and Jacobson's relaxation (control group) to determine the relative effectiveness of each intervention.

Participants will:

Engage in a 20-minute session of one of the assigned interventions. Complete questionnaires on abdomino-pelvic pain, menstrual symptoms, and perceived effectiveness.

Participate in follow-up assessments for sleep quality during menstruation. This study aims to explore innovative, technology-driven approaches for managing menstrual symptoms and their effectiveness relative to traditional methods.

Detailed description: This study seeks to address this gap by investigating whether these innovative approaches can provide superior symptom relief. By evaluating pain intensity, symptom severity, and perceived effectiveness, this research will provide valuable insights into the feasibility and advantages of integrating technology into dysmenorrhea management.

Eligibility criteria: Inclusion Criteria:

* women aged 18-30 with no pregnancy history.
* a regular menstrual cycle (28 ± 7 days) over the past 6 months
* menstrual pain with a Visual Analog Scale score \>4 during this period

Exclusion Criteria:

* regular medication use or medical treatment during the study (e.g., oral contraceptives, antidepressants).
* recent musculoskeletal trauma or surgery.
* intrauterine device use or pathological conditions/ultrasound findings of secondary dysmenorrhea
* consumption of painkillers, alcohol, recreational drugs, or similar substances within the last 48 hours.

Primary outcomes:
measure: Abdomino-Pelvic Pain İntensity (APPI)
timeFrame: Immediately before and immediately after the 20-minute intervention session
measure: Menstruation-Related Symptoms
timeFrame: Immediately before and immediately after the 20-minute intervention session
Secondary outcomes:
measure: Sleep Quality
timeFrame: The morning following the intervention and the morning of the most painful day during the subsequent menstrual cycle.
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
state: İskender
city: Edirne
country: Turkey
facility: Trakya University
Study officials:
References: