[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658411":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":28,"studyPopulation":17,"armGroups":29,"interventions":41,"overallOfficials":17,"centralContacts":46,"locations":52,"responsibleParty":76,"collaborators":17,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":17,"enrollmentInfo":91,"targetDuration":17,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":105,"whyStopped":17,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Tokat Gaziosmanpasa University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"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.","1-3. days",[14],{"measure":15,"description":16,"timeFrame":12},"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",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","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.","SUPPORTIVE_CARE",{"masking":24,"maskingDescription":25,"whoMasked":26},"SINGLE","The study is open-label for participants, care providers, and investigators. The statistician\u002Fdata analyst will be blinded to group allocation during the statistical analysis. Group assignments will be coded without identifying the intervention groups until the primary analyses have been completed.",[27],"OUTCOMES_ASSESSOR","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.\n\nPharmacological 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.\n\nThe 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.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"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.",[35],"Behavioral: Virtual Reality",{"label":37,"type":38,"description":39,"interventionNames":40},"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.",[35],[42],{"type":43,"name":37,"description":44,"armGroupLabels":45,"otherNames":17},"BEHAVIORAL","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.",[31,37],[47],{"name":48,"role":49,"phone":50,"phoneExt":17,"email":51},"Abdurrahim Uyanık, MSc","CONTACT","05419634590","abdurrahim.uyanik@gop.edu.tr",[53,67],{"facility":5,"status":17,"city":54,"state":55,"zip":56,"country":57,"countryCode":17,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Erbaa","Tokat Province","60500","Turkey (Türkiye)",{"type":59,"coordinates":60},"Point",[61,62],36.5675,40.66889,{"lat":62,"lon":61},[65],{"name":66,"role":49,"phone":50,"phoneExt":17,"email":51},"Abdurrahim Uyanık",{"facility":5,"status":17,"city":54,"state":55,"zip":17,"country":57,"countryCode":17,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},{"type":59,"coordinates":69},[61,62],{"lat":62,"lon":61},[72],{"name":73,"role":49,"phone":74,"phoneExt":17,"email":75},"Gözde Taşdemir, Associate Degree","+905434294355","gozdetasdemir72@gmail.com",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Abdurrahim UYANIK","Lecturer","100658411","effect-of-virtual-reality-on-pain-and-anxiety-in-women-with-dysmenorrhea-a-randomized-controlled-trial-100658411",false,"NCT07853508","Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea","Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea: A Randomized Controlled Trial","VR","Inclusion Criteria:\n\n* University students,\n* Diagnosed with primary dysmenorrhea,\n* Having a regular menstrual cycle,\n* Willing to participate in the study,\n* Having no vision or hearing problems.\n\nExclusion Criteria:\n\n* Individuals diagnosed with secondary dysmenorrhea,\n* Individuals experiencing chronic pelvic pain,\n* Individuals with a psychiatric disorder,\n* Individuals using hormonal therapy,\n* Individuals using analgesics during menstruation,\n* Individuals with visual or hearing impairments,\n* Individuals wishing to withdraw at any stage of the study,\n* Individuals who fill out the forms incompletely or fail to fill them out.",true,"FEMALE","18 Years",{"count":92,"type":93},68,"ESTIMATED","INTERVENTIONAL",[96],"NA","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.\n\nParticipants 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.\n\nPain 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.",[99,100,101],"Primary Dysmenorrhea","Menstrual Pain","Anxiety",[99,37,103,101,104],"Pain","Women health","NOT_YET_RECRUITING","2026-10-05",{"date":108,"type":109},"2026-10-07","ACTUAL",{"date":111,"type":93},"2026-09-30",{"date":113,"type":93},"2026-11-30",{"name":5,"class":6},2]