Primary DysmenorrheaVRNCT07853508
Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea
A study testing Virtual Reality in people with Primary Dysmenorrhea and Menstrual Pain, run by Tokat Gaziosmanpasa University at 2 sites in Turkey (Türkiye).
Trial summary
Dysmenorrhea, or painful menstrual periods, is a common condition that can affect daily activities and quality of life. This study aims to evaluate whether using virtual reality (VR) can reduce pain and anxiety in women with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea, Menstrual Pain, Anxiety
- What is being tested?
- Virtual Reality
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Sep 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- University students,
- Diagnosed with primary dysmenorrhea,
- Having a regular menstrual cycle,
- Willing to participate in the study,
- Having no vision or hearing problems.
Who cannot join
- Individuals diagnosed with secondary dysmenorrhea,
- Individuals experiencing chronic pelvic pain,
- Individuals with a psychiatric disorder,
- Individuals using hormonal therapy,
- Individuals using analgesics during menstruation,
- Individuals with visual or hearing impairments,
- Individuals wishing to withdraw at any stage of the study,
- Individuals who fill out the forms incompletely or fail to fill them out.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Tokat Gaziosmanpasa University
Erbaa, Tokat Province, 60500
Abdurrahim Uyanık, 05419634590, abdurrahim.uyanik@gop.edu.tr
Tokat Gaziosmanpasa University
Erbaa, Tokat Province
Gözde Taşdemir, Associate Degree, +905434294355, gozdetasdemir72@gmail.com
About this study
Official title: Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea: A Randomized Controlled Trial
Dysmenorrhea, or painful menstrual periods, is a common condition that can affect daily activities and quality of life. This study aims to evaluate whether using virtual reality (VR) can reduce pain and anxiety in women with primary dysmenorrhea.
Participants will be randomly assigned to either a VR group or a 2D video group. Participants in the VR group will watch a relaxing virtual environment using a VR headset for 20 minutes once a day for three consecutive days. Participants in the 2D video group will watch the same content for the same duration and frequency using a 2D screen, such as a phone, tablet, or computer.
Pain intensity and anxiety levels will be assessed before and after each session during the three-day intervention. The study will compare changes in pain and anxiety between the two groups to evaluate the effect of VR in women with primary dysmenorrhea.
Read the detailed description
Dysmenorrhea is a common menstrual health problem that may negatively affect physical well-being, psychological status, daily activities, and quality of life. Primary dysmenorrhea occurs in the absence of an underlying pelvic pathology and is commonly characterized by cramping pain during menstruation. Pain associated with dysmenorrhea may also be accompanied by psychological symptoms such as anxiety.
Pharmacological treatments are commonly used to manage dysmenorrhea; however, interest in non-pharmacological approaches has increased because of potential limitations and adverse effects associated with medication use. Virtual reality (VR) is a non-pharmacological and non-invasive approach that may help manage pain by directing attention away from painful stimuli and providing an immersive sensory experience.
The purpose of this randomized controlled trial is to evaluate the effect of a relaxing VR-based intervention on pain intensity and anxiety levels among university students with primary dysmenorrhea. The study will also examine changes in these outcomes across repeated measurements during the three-day intervention period. The findings may contribute to the development of non-pharmacological approaches for managing pain and anxiety associated with primary dysmenorrhea.
- Conditions
- Primary Dysmenorrhea, Menstrual Pain, Anxiety
- Being tested
- Virtual Reality
- Keywords
- Primary Dysmenorrhea, Virtual Reality, Pain, Anxiety, Women health
- Medical subject headings
- Dysmenorrhea, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
A 20-minute relaxation video will be presented using a virtual reality (VR) headset. Participants will receive the intervention once daily for three consecutive days during the first three days of menstruation. The VR environment is designed to provide an immersive visual and auditory experience and to direct participants' attention away from menstrual pain.
| Study group | Role | What they receive |
|---|---|---|
| 2D Video | Active comparator | Participants will watch the same 20-minute relaxation video on a conventional 2D screen (e.g., tablet, smartphone, or computer) once daily for three consecutive days during the first three days of menstruation. Pain intensity and state anxiety will be assessed immediately before and after each session. Receives: Behavioral: Virtual Reality |
| Virtual Reality | Experimental | Participants will receive a 20-minute relaxation video through a virtual reality (VR) headset once daily for three consecutive days during the first three days of menstruation. Pain intensity and state anxiety will be assessed immediately before and after each session. Receives: Behavioral: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
This is used to quantify certain values that cannot be measured numerically. The two extremes of the parameter being evaluated are marked at either end of a 100 mm line, and the patient is asked to indicate their current status on this line by drawing a mark, placing a dot, or pointing. For pain assessment, "no pain" is written at one end and "severe pain" at the other; the patient then marks their current pain level on the line. The distance from the "no pain" end to the patient's mark represents the level of pain. Evaluation is performed by calculating the mean of the values obtained from the patients.
Measured: 1-3. days
Secondary outcomes (1)
State Anxiety Inventory (STAI-X)
The State-Trait Anxiety Inventory (STAI) form, developed by Spielberger (1983), is used for adults aged 18-69 and consists of 20 items measuring the intensity of anxiety as an emotional state (state anxiety). Responses on the scale are rated as follows: 1: not at all, 2: somewhat, 3: very much, and 4: completely. If more than three items are left unanswered, the completed form is considered invalid and is not scored. Direct items express negative emotions, while reverse-scored items express positive emotions. During scoring, items with a weight of 1 are converted to 4, and those with a weight of 4 are converted to 1. The state anxiety scale contains ten reverse-scored items: items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. Theoretically, the obtained scores range from 20 to 80. A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety (Spielberger, 1983). The scale was adapted for Turkish culture by Öner and Le Compte, and reliability and validity
Measured: 1-3. days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
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
- Model description
- Participants will be randomly assigned to either a virtual reality (VR) intervention group or a 2D video group. Both groups will receive a 20-minute relaxation video once daily for three consecutive days during the first three days of menstruation. The VR group will watch the content using a VR headset, while the 2D video group will watch the same content on a conventional screen. Pain intensity and state anxiety will be assessed immediately before and after each session. Thus, six repeated measurements will be obtained for each outcome over the three-day intervention period. Randomization will be performed using a computer-generated random sequence by an independent researcher who is not involved in the study procedures.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdurrahim UYANIK, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853508
- Sponsor's protocol ID
- TOGÜ- AUGT
- Acronym
- VR
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. De-identified aggregate data will be reported in publications resulting from this study.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07853508
- Acronym / sponsor ID
- VR / TOGÜ- AUGT
- Conditions
- Primary Dysmenorrhea, Menstrual Pain, Anxiety
- Keywords
- Primary Dysmenorrhea, Virtual Reality, Pain, Anxiety, Women health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 1 Oct 2026 (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.
Dysmenorrhea, or painful menstrual periods, is a common condition that can affect daily activities and quality of life. This study aims to evaluate whether using virtual reality (VR) can reduce pain and anxiety in women with primary dysmenorrhea.
Participants will be randomly assigned to either a VR group or a 2D video group. Participants in the VR group will watch a relaxing virtual environment using a VR headset for 20 minutes once a day for three consecutive days. Participants in the 2D video group will watch the same content for the same duration and frequency using a 2D screen, such as a phone, tablet, or computer.
Pain intensity and anxiety levels will be assessed before and after each session during the three-day intervention. The study will compare changes in pain and anxiety between the two groups to evaluate the effect of VR in women with primary dysmenorrhea.
Detailed description
Dysmenorrhea is a common menstrual health problem that may negatively affect physical well-being, psychological status, daily activities, and quality of life. Primary dysmenorrhea occurs in the absence of an underlying pelvic pathology and is commonly characterized by cramping pain during menstruation. Pain associated with dysmenorrhea may also be accompanied by psychological symptoms such as anxiety.
Pharmacological treatments are commonly used to manage dysmenorrhea; however, interest in non-pharmacological approaches has increased because of potential limitations and adverse effects associated with medication use. Virtual reality (VR) is a non-pharmacological and non-invasive approach that may help manage pain by directing attention away from painful stimuli and providing an immersive sensory experience.
The purpose of this randomized controlled trial is to evaluate the effect of a relaxing VR-based intervention on pain intensity and anxiety levels among university students with primary dysmenorrhea. The study will also examine changes in these outcomes across repeated measurements during the three-day intervention period. The findings may contribute to the development of non-pharmacological approaches for managing pain and anxiety associated with primary dysmenorrhea.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either a virtual reality (VR) intervention group or a 2D video group. Both groups will receive a 20-minute relaxation video once daily for three consecutive days during the first three days of menstruation. The VR group will watch the content using a VR headset, while the 2D video group will watch the same content on a conventional screen. Pain intensity and state anxiety will be assessed immediately before and after each session. Thus, six repeated measurements will be obtained for each outcome over the three-day intervention period. Randomization will be performed using a computer-generated random sequence by an independent researcher who is not involved in the study procedures.
| Arm | Type | Receives |
|---|---|---|
| 2D Video | Active comparator | Behavioral: Virtual RealityParticipants will watch the same 20-minute relaxation video on a conventional 2D screen (e.g., tablet, smartphone, or computer) once daily for three consecutive days during the first three days of menstruation. Pain intensity and state anxiety will be assessed immediately before and after each session. |
| Virtual Reality | Experimental | Behavioral: Virtual RealityParticipants will receive a 20-minute relaxation video through a virtual reality (VR) headset once daily for three consecutive days during the first three days of menstruation. Pain intensity and state anxiety will be assessed immediately before and after each session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- University students,
- Diagnosed with primary dysmenorrhea,
- Having a regular menstrual cycle,
- Willing to participate in the study,
- Having no vision or hearing problems.
Key exclusion criteria (8 listed)
- Individuals diagnosed with secondary dysmenorrhea,
- Individuals experiencing chronic pelvic pain,
- Individuals with a psychiatric disorder,
- Individuals using hormonal therapy,
- Individuals using analgesics during menstruation,
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 |
|---|---|---|
| Virtual RealityA 20-minute relaxation video will be presented using a virtual reality (VR) headset. Participants will receive the intervention once daily for three consecutive days during the first three days of menstruation. The VR environment is designed to provide an immersive visual and auditory experience and to direct participants' attention away from menstrual pain. | Behavioural | 2D Video, Virtual Reality |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 1-3. days
This is used to quantify certain values that cannot be measured numerically. The two extremes of the parameter being evaluated are marked at either end of a 100 mm line, and the patient is asked to indicate their current status on this line by drawing a mark, placing a dot, or pointing. For pain assessment, "no pain" is written at one end and "severe pain" at the other; the patient then marks their current pain level on the line. The distance from the "no pain" end to the patient's mark represents the level of pain. Evaluation is performed by calculating the mean of the values obtained from the patients.
1 secondary outcome
State Anxiety Inventory (STAI-X)
Time frame: 1-3. days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. De-identified aggregate data will be reported in publications resulting from this study.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Primary Dysmenorrhea and Menstrual Pain, run by Tokat Gaziosmanpasa 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdurrahim Uyanık, MSc (05419634590, abdurrahim.uyanik@gop.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 1-3. days). 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 7 Oct 2026.