- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07633990
The Effect of vırtual realıty on paın and Sleep qualıty ın Women
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.
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 Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Baykan
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Siirt, Baykan, Turkey (Türkiye), 56460
- Baykan State Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: experiment
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.
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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 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 Names:
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Placebo Comparator: control
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.
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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:
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Distribution of women according to the characteristics of their menstrual cycles
Time Frame: 4 weeks
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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.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison of Participants' Sociodemographic Characteristics by Group
Time Frame: 2 weeks
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This table presents sociodemographic data such as women's marital status, age, and chronic conditions.
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2 weeks
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A Comparison of Certain Characteristics of Participants' Menstrual Cycles Across Groups
Time Frame: 4 weeks
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This table presents data such as the age at first menstruation, menstrual cycle length, and duration of menstrual bleeding
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4 weeks
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Comparison of Dysmenorrhea Characteristics Among Participants by Group
Time Frame: 4 weeks
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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.
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4 weeks
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Comparison of Participants' Sleep-Related Characteristics by Group
Time Frame: 4 weeks
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This table provides information on a woman's sleep patterns during her menstrual cycle
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4 weeks
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Comparisons of Participants' Visual Analog Scale (VAS) Scores Between and Within Groups
Time Frame: 6 weeks
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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. |
6 weeks
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Comparisons of Participants' Richard Campbell Sleep Scale (RCSQ) Scores Across and Within Groups
Time Frame: 6 weeks
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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.
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Remzi KARASUNGUR, not affiliated
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Pathologic Processes
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Pelvic Pain
- Menstruation Disturbances
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Sleep Initiation and Maintenance Disorders
- Dysmenorrhea
- Therapeutics
- Complementary Therapies
- Patient Care
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Sensory Art Therapies
- Music Therapy
Other Study ID Numbers
- HKÜ-HEM-RK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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