DysmenorrheaNCT07633990
The Effect of vırtual realıty on paın and Sleep qualıty ın Women
A study testing experiment in people with Dysmenorrhea, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine whether a video viewed through virtual reality goggles accompanied by music has an effect on pain and sleep quality in women with dysmenorrhea. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- experiment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2023to 24 Sep 2023
- 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 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women who volunteered to participate in the study,
- Who are at least literate,
- Aged 15-49 and not yet in menopause,
- Who are not pregnant,
- Who have been diagnosed with dysmenorrhea by a physician and have a pain intensity of at least 4 on the Visual Analogue Scale
Who cannot join
- Women with dysmenorrhea pain intensity below 4 on the Visual Analog Scale,
- Women with vision or hearing impairments,
- Women who are unwilling to participate in the study,
- Women using analgesic medications for menstrual pain,
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of vıdeo Watched wıth musıc Through vırtual realıty Glasses and musıc lıstenıng Alone on paın and Sleep qualıty ın Women wıth Dysmenorrhea
The aim of this study is to determine whether a video viewed through virtual reality goggles accompanied by music has an effect on pain and sleep quality in women with dysmenorrhea. The main questions it seeks to answer are as follows:
- Does watching a video through virtual reality goggles accompanied by music reduce pain in women with dysmenorrhea?
- Does watching a video through virtual reality goggles accompanied by music improve sleep quality in women with dysmenorrhea? The study will compare a group that uses music from the virtual reality video with another group to determine whether the virtual reality application has an effect on pain and sleep quality.
Read more
Participants will do the following:
For 3 days, use the virtual reality or music application every evening before going to bed after completing the VAS. The next day, after waking up, complete the VAS and the sleep quality scale and record the results.
- Conditions
- Dysmenorrhea
- Being tested
- experiment, Control
- Keywords
- Dysmenorrhea, Virtual Reality, Music, Pain, Sleep Quality
- Medical subject headings
- Dysmenorrhea, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimentOther
Also called Virtual Reality
Group shown a video using a virtual reality headset: A video containing images of nature and waterfalls is downloaded to a phone and provided to the participant ready to use inside a virtual reality headset; the procedure is carried out as described below.
For three consecutive days, each day:
- After menstruation begins, apply the VAS pain scale before going to bed in the evening
- In the evening, in a dark and quiet environment, watch the 30-minute virtual reality video as instructed by the researcher until falling asleep
- The following morning, apply the VAS pain scale and RCUÖ and inform the researcher.
After the study was completed, the equipment returned to the researcher was calibrated and cleaned as necessary by the researcher and prepared for use with another patient.
ControlOther
Also called music
Unlike the intervention group, the women in the control group were given an MP3 player by the researcher, instructed on how to use it, and had the music used in the virtual reality video loaded onto it for them to listen to.
For three consecutive days, each day:
- Apply the VAS pain scale in the evening before going to bed after menstruation has occurred
- Listen to the 30-minute music in a dark and quiet environment in the evening, as instructed by the researcher
- Apply the VAS pain scale and RCUÖ the following morning and inform the researcher.
After the study was completed, the equipment returned to the researcher was calibrated and cleaned as necessary by the researcher and prepared for use with another patient.
| Study group | Role | What they receive |
|---|---|---|
| experiment | Experimental | Group shown a video using a virtual reality headset: For this experiment, a video featuring nature scenes and waterfalls was downloaded to a phone, loaded into a virtual reality headset, and provided to the participant ready for use. Receives: Other: experiment |
| control | Placebo comparator | Unlike the intervention group, the women in the control group were given MP3 players by the researcher, instructed on how to use them, and had the music used in the virtual reality video loaded onto the devices for them to listen to. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of women according to the characteristics of their menstrual cycles
This table includes the latest menstrual pain scale, the occurrence of pain during the menstrual cycle, the type of dysmenorrhea, the timing of dysmenorrhea, information about menstruation, who provided information about menstruation, the use of pain relievers during the menstrual period, non-pharmacological interventions used to alleviate menstrual pain, non-pharmacological interventions used to alleviate menstrual pain, the presence of dysmenorrhea in the family, and gynecological diagnosis data. Patients with a pain scale (VAS) score of 4 or higher were evaluated, and the analysis proceeded to secondary outcomes.
Measured: 4 weeks
Secondary outcomes (6)
Comparison of Participants' Sociodemographic Characteristics by Group
This table presents sociodemographic data such as women's marital status, age, and chronic conditions.
Measured: 2 weeks
A Comparison of Certain Characteristics of Participants' Menstrual Cycles Across Groups
This table presents data such as the age at first menstruation, menstrual cycle length, and duration of menstrual bleeding
Measured: 4 weeks
Comparison of Dysmenorrhea Characteristics Among Participants by Group
This table examines data such as the onset of dysmenorrhea, the presence of dysmenorrhea in the family, the family history of dysmenorrhea, the severity of pain during menstruation, and the use of pain relievers during menstruation.
Measured: 4 weeks
Comparison of Participants' Sleep-Related Characteristics by Group
This table provides information on a woman's sleep patterns during her menstrual cycle
Measured: 4 weeks
Comparisons of Participants' Visual Analog Scale (VAS) Scores Between and Within Groups
A visual analog scale is a pain assessment tool where individuals mark their pain level on a horizontal bar ranging from 0 to 10. The starting point of the scale indicates the absence of pain, while the end point indicates that the pain is unbearable.
This table shows the woman's pain scale assessment.
Measured: 6 weeks
Comparisons of Participants' Richard Campbell Sleep Scale (RCSQ) Scores Across and Within Groups
The Richard Campbell Sleep Scale assesses the depth of sleep, the time it takes to fall asleep, the frequency of waking, the duration of wakefulness upon waking, the quality of sleep, and the noise level in the environment. Each item on the scale is scored on a scale of 0 to 100. A score of "0-25" indicates "very poor sleep," while a score of "76-100" indicates "very good sleep." When calculating the total scale score, the scores from the 5 items are added together; the noise level in the environment is not included in the total score calculation.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start5 Jan 2023
- Primary completion29 Mar 2023
- Study completion24 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remzi KARASUNGUR, Hasan Kalyoncu University
- Investigators
- Remzi KARASUNGUR, Study director, not affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633990
- Sponsor's protocol ID
- HKÜ-HEM-RK-01
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: When our study is published as an article, the data on the individuals will be presented to researchers in tabular
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of vıdeo Watched wıth musıc Through vırtual realıty Glasses and musıc lıstenıng Alone on paın and Sleep qualıty ın Women wıth Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07633990
- Acronym / sponsor ID
- HKÜ-HEM-RK-01
- Conditions
- Dysmenorrhea
- Keywords
- Dysmenorrhea, Virtual Reality, Music, Pain, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 24 Sep 2023 (actual)
- First posted
- 8 Jun 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.
The aim of this study is to determine whether a video viewed through virtual reality goggles accompanied by music has an effect on pain and sleep quality in women with dysmenorrhea. The main questions it seeks to answer are as follows:
- Does watching a video through virtual reality goggles accompanied by music reduce pain in women with dysmenorrhea?
- Does watching a video through virtual reality goggles accompanied by music improve sleep quality in women with dysmenorrhea? The study will compare a group that uses music from the virtual reality video with another group to determine whether the virtual reality application has an effect on pain and sleep quality.
Participants will do the following:
For 3 days, use the virtual reality or music application every evening before going to bed after completing the VAS. The next day, after waking up, complete the VAS and the sleep quality scale and record the results.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment | Experimental | Other: experimentGroup shown a video using a virtual reality headset: For this experiment, a video featuring nature scenes and waterfalls was downloaded to a phone, loaded into a virtual reality headset, and provided to the participant ready for use. |
| control | Placebo comparator | Other: ControlUnlike the intervention group, the women in the control group were given MP3 players by the researcher, instructed on how to use them, and had the music used in the virtual reality video loaded onto the devices for them to listen to. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Women who volunteered to participate in the study,
- Who are at least literate,
- Aged 15-49 and not yet in menopause,
- Who are not pregnant,
- Who have been diagnosed with dysmenorrhea by a physician and have a pain intensity of at least 4 on the Visual Analogue Scale
Key exclusion criteria (5 listed)
- Women with dysmenorrhea pain intensity below 4 on the Visual Analog Scale,
- Women with vision or hearing impairments,
- Women who are unwilling to participate in the study,
- Women using analgesic medications for menstrual pain,
- Pregnant women
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 |
|---|---|---|
| experimentAlso: Virtual RealityGroup shown a video using a virtual reality headset: A video containing images of nature and waterfalls is downloaded to a phone and provided to the participant ready to use inside a virtual reality headset; the procedure is carried out as described below. For three consecutive days, each day: * After menstruation begins, apply the VAS pain scale before going to bed in the evening * In the evening, in a dark and quiet environment, watch the 30-minute virtual reality video as instructed by the researcher until falling asleep * The following morning, apply the VAS pain scale and RCUÖ and inform the researcher. After the study was completed, the equipment returned to the researcher was calibrated and cleaned as necessary by the researcher and prepared for use with another patient. | Other | experiment |
| ControlAlso: musicUnlike the intervention group, the women in the control group were given an MP3 player by the researcher, instructed on how to use it, and had the music used in the virtual reality video loaded onto it for them to listen to. For three consecutive days, each day: * Apply the VAS pain scale in the evening before going to bed after menstruation has occurred * Listen to the 30-minute music in a dark and quiet environment in the evening, as instructed by the researcher * Apply the VAS pain scale and RCUÖ the following morning and inform the researcher. After the study was completed, the equipment returned to the researcher was calibrated and cleaned as necessary by the researcher and prepared for use with another patient. | Other | control |
Primary outcome
Distribution of women according to the characteristics of their menstrual cycles
Time frame: 4 weeks
This table includes the latest menstrual pain scale, the occurrence of pain during the menstrual cycle, the type of dysmenorrhea, the timing of dysmenorrhea, information about menstruation, who provided information about menstruation, the use of pain relievers during the menstrual period, non-pharmacological interventions used to alleviate menstrual pain, non-pharmacological interventions used to alleviate menstrual pain, the presence of dysmenorrhea in the family, and gynecological diagnosis data. Patients with a pain scale (VAS) score of 4 or higher were evaluated, and the analysis proceeded to secondary outcomes.
6 secondary outcomes
Comparison of Participants' Sociodemographic Characteristics by Group
Time frame: 2 weeks
A Comparison of Certain Characteristics of Participants' Menstrual Cycles Across Groups
Time frame: 4 weeks
Comparison of Dysmenorrhea Characteristics Among Participants by Group
Time frame: 4 weeks
Comparison of Participants' Sleep-Related Characteristics by Group
Time frame: 4 weeks
Comparisons of Participants' Visual Analog Scale (VAS) Scores Between and Within Groups
Time frame: 6 weeks
Comparisons of Participants' Richard Campbell Sleep Scale (RCSQ) Scores Across and Within Groups
Time frame: 6 weeks
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 8 Jun 2026.
- Individual participant dataSharing planned: Undecided. When our study is published as an article, the data on the individuals will be presented to researchers in tabular
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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.
Remzi KARASUNGUR study director
not affiliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experiment in people with Dysmenorrhea, run by Hasan Kalyoncu University at 1 site 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 5 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Distribution of women according to the characteristics of their menstrual cycles (time frame: 4 weeks). 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 8 Jun 2026.