Virtual Reality-Based Relaxation and Exergaming vs. Traditional Relaxation for Primer Dysmenorrhea

NCT06728306 | Completed

• 2 other identifiers: TU-FTR-MŞY-0021919B012219298
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

Primary Dysmenorrhea

Keywords

Exercise Therapy; Pain Management; Primary Dysmenorrhea; Progressive Muscle Relaxation; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• Abdomino-Pelvic Pain İntensity (APPI)

  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.

  Immediately before and immediately after the 20-minute intervention session

• Menstruation-Related Symptoms

  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 .

  Immediately before and immediately after the 20-minute intervention session

Secondary Outcomes (1)

• Sleep Quality

  The morning following the intervention and the morning of the most painful day during the subsequent menstrual cycle.

Study Arms (3)

Immersive Virtual Reality Based Relaxation

EXPERIMENTAL

Behavioral: Immersive Virtual Reality-Based Relaxation

Non-Immersive Virtual Reality Based Exergaming

EXPERIMENTAL

Behavioral: Non-immersive VR-Based Exergaming

Traditional Jacobson's Relaxation

ACTIVE COMPARATOR

Behavioral: Jacobson's Relaxation

Interventions

Immersive Virtual Reality-Based Relaxation BEHAVIORAL

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.

Immersive Virtual Reality Based Relaxation

Non-immersive VR-Based Exergaming BEHAVIORAL

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

Non-Immersive Virtual Reality Based Exergaming

Jacobson's Relaxation BEHAVIORAL

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

Traditional Jacobson's Relaxation

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trakya University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (2)

Trakya University

Edirne, İskender, 22100, Turkey (Türkiye)

Location

Trakya University

Edirne, 22100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 11, 2024
• Study Start: May 12, 2023
• Primary Completion: February 4, 2024
• Study Completion: February 5, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)