Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea: A Randomized Controlled Trial

NCT07853508 | Not Yet Recruiting

• 1 other identifier: TOGÜ- AUGT
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Primary Dysmenorrhea; Menstrual Pain; Anxiety

Keywords

Primary Dysmenorrhea; Virtual Reality; Pain; Anxiety; Women health

Outcome Measures

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.

  1-3. days

Secondary Outcomes (1)

• State Anxiety Inventory (STAI-X)

  1-3. days

Study Arms (2)

2D Video Group

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.

Behavioral: Virtual Reality

Virtual Reality Group

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.

Behavioral: Virtual Reality

Interventions

Virtual Reality 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.

2D Video Group; Virtual Reality Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who self-identify as female are eligible to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• University students,
• Diagnosed with primary dysmenorrhea,
• Having a regular menstrual cycle,
• Willing to participate in the study,
• Having no vision or hearing problems.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (2)

Tokat Gaziosmanpasa University

Erbaa, Tokat Province, 60500, Turkey (Türkiye)

Location

Tokat Gaziosmanpasa University

Erbaa, Tokat Province, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Central Study Contacts

Abdurrahim Uyanık, MSc

CONTACT

05419634590; abdurrahim.uyanik@gop.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study is open-label for participants, care providers, and investigators. The statistician/data 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 1, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)