Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTokat Gaziosmanpasa University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
University students,
Diagnosed with primary dysmenorrhea,
Having a regular menstrual cycle,
Willing to participate in the study,
Disqualifiers
Individuals diagnosed with secondary dysmenorrhea,
Individuals experiencing chronic pelvic pain,
Individuals with a psychiatric disorder,
Individuals using hormonal therapy,
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality
BehavioralA 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.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: 2D VideoActive comparator 1 intervention
Group B: Virtual RealityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1-3. daysSecondary 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
Time frame
1-3. daysSponsors and contacts
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Source ClinicalTrials.gov
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