- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07778355
Operating Room Orientation Video Education in Patients Undergoing Prostate Surgery
The Effect of Operating Room Orientation Video Education Applied at Different Times on Postoperative Pain and Anxiety in Patients Undergoing Prostate Surgery
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The study will evaluate whether the timing of operating room orientation video education influences postoperative pain and state anxiety in patients undergoing surgery for benign prostatic hyperplasia. The intervention consists of a 5-minute video designed to familiarize patients with the perioperative environment and expected procedures. The video includes information about the operating room environment, the operating table, patient positioning, information related to the surgical process, the post-anesthesia care unit, and patient transfer.
Participants will be randomly allocated in a 1:1:1 ratio to one of three parallel groups. Participants in the first intervention group will receive the video approximately one day before surgery in the surgical ward. Participants in the second intervention group will receive the same video approximately 30 minutes before surgery in the operating room waiting unit. Participants in the control group will receive routine preoperative information according to standard clinical practice.
Pain intensity will be assessed using the Visual Analog Scale, and state anxiety will be assessed using the State-Trait Anxiety Inventory-State Anxiety Scale. Assessments will be performed one day before surgery, before the intervention in the operating room waiting unit, and six hours after surgery in the surgical ward.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Beyza Çakır
- Telefonnummer: +905372600955
- E-post: beyzacakir7856@gmail.com
Studieorter
-
-
Atakum
-
Samsun, Atakum, Turkiet (Türkiye), 55500
- Ondokuz Mayıs University Health Practice and Research Center
-
Kontakt:
- Beyza Çakır
- Telefonnummer: +905372600955
- E-post: beyzacakir7856@gmail.com
-
Huvudutredare:
- Beyza Çakır
-
Underutredare:
- Özge İşeri, Associate professor
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Being conscious and able to communicate. Being able to read and understand Turkish. Voluntarily agreeing to participate in the study and providing informed consent.
Having no visual or hearing impairment that would interfere with viewing the educational video or completing the study assessments.
Undergoing prostate surgery for the first time. Being 18 years of age or older.
Exclusion Criteria:
- Having a diagnosed psychiatric disorder. Having a chronic pain syndrome. Being scheduled for emergency surgery. Having previously received similar operating room orientation education.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Ward Video Education Group
Participants will receive a 5-minute operating room orientation video approximately one day before surgery in the surgical ward.
|
A 5-minute video-based educational intervention designed to familiarize patients with the operating room environment and the perioperative process.
The video includes information about the operating room environment, operating table, patient positioning, information related to the surgical process, the post-anesthesia care unit, and patient transfer.
|
|
Experimentell: Operating Room Waiting Unit Video Education Group
Participants will receive the same 5-minute operating room orientation video approximately 30 minutes before surgery in the operating room waiting unit.
|
A 5-minute video-based educational intervention designed to familiarize patients with the operating room environment and the perioperative process.
The video includes information about the operating room environment, operating table, patient positioning, information related to the surgical process, the post-anesthesia care unit, and patient transfer.
|
|
Aktiv komparator: Routine Information Control Group
Participants will receive routine preoperative information according to standard clinical practice without the study-specific operating room orientation video.
|
Participants will receive routine preoperative information according to standard clinical practice without the study-specific operating room orientation video.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative state anxiety
Tidsram: From baseline to 6 hours after surgery
|
State anxiety will be assessed using the State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S), using the Turkish adaptation by Necla Öner and Ayhan Le Compte.
State anxiety will be assessed one day before surgery in the surgical ward, before video education in the operating room waiting unit, and 6 hours after surgery in the surgical ward.
The primary postoperative assessment will be the STAI-S score at 6 hours after surgery.
|
From baseline to 6 hours after surgery
|
|
Postoperative pain intensity
Tidsram: From baseline to 6 hours after surgery
|
Pain intensity will be assessed using the Visual Analog Scale (VAS).
Pain will be assessed one day before surgery in the surgical ward, before video education in the operating room waiting unit, and 6 hours after surgery in the surgical ward.
The primary postoperative assessment will be the VAS score at 6 hours after surgery.
|
From baseline to 6 hours after surgery
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Smärta
- Neurologiska manifestationer
- Mentala störningar
- Postoperativa komplikationer
- Patologiska processer
- Genitala sjukdomar, manliga
- Prostatasjukdomar
- Manliga urogenitala sjukdomar
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Smärta, postoperativt
- Ångeststörningar
- Prostatahyperplasi
Andra studie-ID-nummer
- 2025/1127
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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