- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Baykan
-
Siirt, Baykan, Turchia (Türkiye), 56460
- Baykan State Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
Altri nomi:
|
|
Comparatore placebo: 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.
|
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Distribution of women according to the characteristics of their menstrual cycles
Lasso di tempo: 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.
|
4 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Comparison of Participants' Sociodemographic Characteristics by Group
Lasso di tempo: 2 weeks
|
This table presents sociodemographic data such as women's marital status, age, and chronic conditions.
|
2 weeks
|
|
A Comparison of Certain Characteristics of Participants' Menstrual Cycles Across Groups
Lasso di tempo: 4 weeks
|
This table presents data such as the age at first menstruation, menstrual cycle length, and duration of menstrual bleeding
|
4 weeks
|
|
Comparison of Dysmenorrhea Characteristics Among Participants by Group
Lasso di tempo: 4 weeks
|
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.
|
4 weeks
|
|
Comparison of Participants' Sleep-Related Characteristics by Group
Lasso di tempo: 4 weeks
|
This table provides information on a woman's sleep patterns during her menstrual cycle
|
4 weeks
|
|
Comparisons of Participants' Visual Analog Scale (VAS) Scores Between and Within Groups
Lasso di tempo: 6 weeks
|
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
|
|
Comparisons of Participants' Richard Campbell Sleep Scale (RCSQ) Scores Across and Within Groups
Lasso di tempo: 6 weeks
|
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.
|
6 weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Remzi KARASUNGUR, not affiliated
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Disordini mentali
- Processi patologici
- Disturbi del sonno e della veglia
- Disturbi del sonno, intrinseci
- Dissonnie
- Dolore pelvico
- Disturbi delle mestruazioni
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Dolore
- Disturbi dell'inizio e del mantenimento del sonno
- Dismenorrea
- Terapie
- Terapie complementari
- Cura del paziente
- Psicoterapia
- Discipline e attività comportamentali
- Riabilitazione
- Assistenza post -terapia
- Continuità della cura del paziente
- Terapie artistiche sensoriali
- Musicoterapia
Altri numeri di identificazione dello studio
- HKÜ-HEM-RK-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .