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

NCT06728306 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-12-11

No results posted yet for this study

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

Interventions

BEHAVIORAL

Immersive 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.

BEHAVIORAL

Non-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

BEHAVIORAL

Jacobson'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 & Collaborators

  • The Scientific and Technological Research Council of Turkey

    collaborator OTHER
  • Trakya University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-12
Primary Completion
2024-02-04
Completion
2024-02-05

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06728306 on ClinicalTrials.gov