Primary DysmenorrheaNCT06728306
Virtual Reality-Based Relaxation and Exergaming vs. Traditional Relaxation for Primer Dysmenorrhea
A study testing Immersive Virtual Reality-Based Relaxation, Non-immersive VR-Based Exergaming and Jacobson's Relaxation in people with Primary Dysmenorrhea, run by Trakya University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Immersive Virtual Reality-Based Relaxation, Non-immersive VR-Based Exergaming and Jacobson's Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 12 May 2023to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Trakya University
Edirne, İskender, 22100
Trakya University
Edirne, 22100
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Immersive Virtual Reality-Based Relaxation, Non-immersive VR-Based Exergaming, Jacobson's Relaxation
- Keywords
- Exercise Therapy, Pain Management, Primary Dysmenorrhea, Progressive Muscle Relaxation, Virtual Reality
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality-Based RelaxationBehavioural
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.
Non-immersive VR-Based ExergamingBehavioural
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
Jacobson's RelaxationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality Based Relaxation | Experimental | Not described Receives: Behavioral: Immersive Virtual Reality-Based Relaxation |
| Non-Immersive Virtual Reality Based Exergaming | Experimental | Not described Receives: Behavioral: Non-immersive VR-Based Exergaming |
| Traditional Jacobson's Relaxation | Active comparator | Not described Receives: Behavioral: Jacobson's Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: Immediately before and immediately after the 20-minute intervention session
Secondary outcomes (1)
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.
Measured: The morning following the intervention and the morning of the most painful day during the subsequent menstrual cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start12 May 2023
- Primary completion4 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Muhammed Şeref Yıldırım, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728306
- Sponsor's protocol ID
- TU-FTR-MŞY-002
- Other IDs
- 1919B012219298
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Impact of Virtual Reality-Based Relaxation and Exergaming Compared to Traditional Relaxation on Primary Dysmenorrhea Symptoms: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06728306
- Acronym / sponsor ID
- TU-FTR-MŞY-002
- Conditions
- Primary Dysmenorrhea
- Keywords
- Exercise Therapy, Pain Management, Primary Dysmenorrhea, Progressive Muscle Relaxation, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 12 May 2023 (actual)
- Primary completion
- 4 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual Reality-Based RelaxationParticipants 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. | Behavioural | Immersive Virtual Reality Based Relaxation |
| Non-immersive VR-Based ExergamingParticipants 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 | Behavioural | Non-Immersive Virtual Reality Based Exergaming |
| Jacobson's RelaxationParticipants 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 | Behavioural | Traditional Jacobson's Relaxation |
Primary outcome
Abdomino-Pelvic Pain İntensity (APPI)
Time frame: 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
Time frame: 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 .
1 secondary outcome
Sleep Quality
Time frame: The morning following the intervention and the morning of the most painful day during the subsequent menstrual cycle.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality-Based Relaxation, Non-immersive VR-Based Exergaming and Jacobson's Relaxation in people with Primary Dysmenorrhea, run by Trakya University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdomino-Pelvic Pain İntensity (APPI) (time frame: Immediately before and immediately after the 20-minute intervention session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.