- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Baykan
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Siirt, Baykan, Tyrkiet (Türkiye), 56460
- Baykan State Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
Andre navne:
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Placebo komparator: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Distribution of women according to the characteristics of their menstrual cycles
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Comparison of Participants' Sociodemographic Characteristics by Group
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Remzi KARASUNGUR, not affiliated
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Psykiske lidelser
- Patologiske processer
- Søvnvågningsforstyrrelser
- Søvnforstyrrelser, iboende
- Dyssomnier
- Bækkensmerter
- Menstruationsforstyrrelser
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Smerte
- Søvninitiering og vedligeholdelsesforstyrrelser
- Dysmenoré
- Terapeutik
- Komplementære terapier
- Patientpleje
- Psykoterapi
- Adfærdsdiscipliner og aktiviteter
- Rehabilitering
- Efterpleje
- Kontinuitet i patientpleje
- Sensoriske kunstterapier
- Musikterapi
Andre undersøgelses-id-numre
- HKÜ-HEM-RK-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med experiment
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King's College LondonRekrutteringKirurgi | Patienttilfredshed | Patientpræference | Muskelinvasiv blærekræft | Seksuel velværeDet Forenede Kongerige