Primary Dysmenorrhea
Conditions
Keywords
Exercise Therapy, Pain Management, Primary Dysmenorrhea, Progressive Muscle Relaxation, Virtual Reality
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.
Interventions
BEHAVIORALImmersive Virtual Reality-Based Relaxation
Participants experienced a 20-minute immersive relaxation session using the virtual reality headset and the Nature Treks application, while seated comfortably. Participants were instructed to select the natural environment they found most relaxing from options such as Blue Ocean, Orange Sunset, Violet Down, White Winter, and Green Meadows, and spent 20 minutes immersed in their chosen virtual environment.
BEHAVIORALNon-immersive VR-Based Exergaming
Participants engaged in a 20-minute calisthenic exercise session guided by the Kinect Adventures game on the Xbox Kinect 360 system. The exercise session consisted of playing two rounds each of the game segments 20,000 Leaks, Reflex Ridge, and River Rush, each lasting approximately 3 minutes
BEHAVIORALJacobson's Relaxation
Participants underwent 20 minutes of progressive relaxation training as developed by Dr. Jacobson. The training involves a series of deep diaphragmatic breaths followed by the systematic tensing and relaxing of 16 major muscle groups throughout the body. Participants were guided through the exercise by an approximately 20-minute audio recording prepared by a psychologist and available online
Sponsors
The Scientific and Technological Research Council of Turkey
Trakya University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdomino-Pelvic Pain İntensity (APPI) | Immediately before and immediately after the 20-minute intervention session | Visuel Analogue Scale was used to measure abdomino-pelvic pain intensity. A 10 cm line was labeled with 0 cm indicating no pain and 10 cm representing unbearable pain at each end. Participants were asked to indicate their pain level by either drawing a line, placing a dot, or marking a point along the scale. Pain assessments were made for the most painful menstrual day and abdomino-pelvic pain on the intervention day. |
| Menstruation-Related Symptoms | Immediately before and immediately after the 20-minute intervention session | The Daily Symptom Rating Scale (DSRS), a 17-item self-report tool, was used to assess the intensity of various menstrual symptoms, including pain, mood swings, and physical discomfort. Each symptom was rated on a scale from 0 (no symptoms) to 5 (severe), with higher scores indicating greater symptom severity. The Turkish version of the scale has been validated and shown to be reliable . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | The morning following the intervention and the morning of the most painful day during the subsequent menstrual cycle. | Richard Campbell Sleep Questionairre was used to assess sleep quality on the night following the intervention and during a non-intervention menstruation day. The six-item self-report questionnaire, validated in Turkish, evaluates aspects such as sleep depth, latency, frequency of awakenings, and overall quality, with higher scores indicating better sleep quality. |
Countries
Turkey (Türkiye)
Outcome results
None listed