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

Acute Impact of Virtual Reality-Based Relaxation and Exergaming Compared to Traditional Relaxation on Primary Dysmenorrhea Symptoms: A Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Behavioral: Immersive Virtual Reality-Based Relaxation; Behavioral: Non-immersive VR-Based Exergaming; Behavioral: Jacobson's Relaxation

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Edirne, Turkey, 22100
    • Trakya University
  • İskender
    • Edirne, İskender, Turkey, 22100
      • Trakya University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immersive Virtual Reality Based Relaxation	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.
Experimental: Non-Immersive Virtual Reality Based Exergaming	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
Active Comparator: Traditional Jacobson's Relaxation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality	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.	The morning following the intervention and the morning of the most painful day during the subsequent menstrual cycle.

Collaborators and Investigators

• Sponsor: Trakya University
• Collaborators: The Scientific and Technological Research Council of Turkey

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Actual): February 4, 2024
• Study Completion (Actual): February 5, 2024

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Reality; Exercise Therapy; Pain Management; Primary Dysmenorrhea; Progressive Muscle Relaxation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Dysmenorrhea
• Other Study ID Numbers: TU-FTR-MŞY-002; 1919B012219298 (Other Grant/Funding Number: The Scientific and Technological Research Council of Turkey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No