- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07728903
Effect of Watching a Comedy Video on Anxiety, Pain, Procedural Readiness, and Uroflowmetric Parameters in Patients Undergoing Urodynamic Testing
Effect of Watching a Comedy Video on Anxiety, Pain, Procedural Readiness, and Uroflowmetric Parameters in Patients Undergoing Urodynamic Testing: A Randomized Controlled Trial
This study aims to determine the effects of watching a comedy video on anxiety, pain, procedural readiness, and uroflowmetric parameters in patients undergoing urodynamic testing.
Data will be collected using the Descriptive Characteristics Form, State Anxiety Inventory (SAI), Visual Analog Scale (VAS), Procedural Readiness Form, and Uroflowmetric Parameters Monitoring Form.
Upon admission to the urodynamic unit, all participants will complete the Descriptive Characteristics Form, State Anxiety Inventory, and Procedural Readiness Form under the supervision of researcher GB.
Participants assigned to the control group will receive the institution's standard pre-procedural care. As part of routine clinical practice, patients will wait in the designated waiting area until their scheduled procedure time. When called to the urodynamic unit, they will receive the standard pre-procedural information routinely provided by the clinic. Patients will then be asked to remove their clothing and assume the appropriate position for the procedure. Urodynamic catheters will be inserted according to the institutional protocol, and the urodynamic examination will be performed. During the procedure, bladder filling and voiding functions will be evaluated. After completion of the examination, the catheters will be removed, and patients will be discharged according to routine clinical practice.
Participants assigned to the intervention group will watch a 15-minute comedy video on a tablet computer immediately before the urodynamic procedure under the supervision of researcher EKD. The video will be viewed in the patient's room under the supervision of a healthcare professional. The video material will consist of scenes carefully selected by the researchers to exclude violence, insults, profanity, sexual content, discrimination, or intense conflict that might evoke negative emotional responses. The selection of the video content will also consider cultural appropriateness, comprehensibility, and broad public appeal.
Short humorous scenes without negative content will be selected from popular 1970s Turkish comedy films starring Kemal Sunal, including Erkek Güzeli Sefil Bilo, İnek Şaban, Hababam Sınıfı, and similar productions. These clips will be compiled into a single standardized video lasting approximately 15 minutes, and all participants in the intervention group will watch the same video in the same sequence.
During the urodynamic procedure, uroflowmetric parameters will be recorded in the Uroflowmetric Parameters Monitoring Form by researcher GB.
Immediately after completion of the procedure, procedural pain will be assessed using the Visual Analog Scale (VAS), which will be administered by researcher GB.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This study aims to determine the effects of watching a comedy video on anxiety, pain, procedural readiness, and uroflowmetric parameters in patients undergoing urodynamic testing. The study is designed as a prospective, randomized controlled clinical trial.
Data will be collected using the Descriptive Characteristics Form, State Anxiety Inventory (SAI), Visual Analog Scale (VAS), Procedural Readiness Form, and Uroflowmetric Parameters Monitoring Form.
Upon admission to the urodynamic unit, all participants will complete the Descriptive Characteristics Form, State Anxiety Inventory, and Procedural Readiness Form under the supervision of researcher GB.
Participants assigned to the control group will receive the institution's standard pre-procedural care. As part of routine clinical practice, patients will wait in the designated waiting area until their scheduled procedure time. When called to the urodynamic unit, they will receive the standard pre-procedural information routinely provided by the clinic. Patients will then be asked to remove their clothing and assume the appropriate position for the procedure. Urodynamic catheters will be inserted according to the institutional protocol, and the urodynamic examination will be performed. During the procedure, bladder filling and voiding functions will be evaluated. After completion of the examination, the catheters will be removed, and patients will be discharged according to routine clinical practice.
Participants assigned to the intervention group will watch a 15-minute comedy video on a tablet computer immediately before the urodynamic procedure under the supervision of researcher EKD. The video will be viewed in the patient's room under the supervision of a healthcare professional. The video material will consist of scenes carefully selected by the researchers to exclude violence, insults, profanity, sexual content, discrimination, or intense conflict that might evoke negative emotional responses. The selection of the video content will also consider cultural appropriateness, comprehensibility, and broad public appeal.
Short humorous scenes without negative content will be selected from popular 1970s Turkish comedy films starring Kemal Sunal, including Erkek Güzeli Sefil Bilo, İnek Şaban, Hababam Sınıfı, and similar productions. These clips will be compiled into a single standardized video lasting approximately 15 minutes, and all participants in the intervention group will watch the same video in the same sequence. The content validity of the developed video will be evaluated by three experts (one urologist, one nurse, and one academician) using the Davis technique.
During the urodynamic procedure, uroflowmetric parameters will be recorded in the Uroflowmetric Parameters Monitoring Form by researcher GB.
Immediately after completion of the procedure, procedural pain will be assessed using the Visual Analog Scale (VAS), which will be administered by researcher GB.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Gamze Bozkul
- Telefonní číslo: +903246000033
- E-mail: gamze.bozkul@gmail.com
Studijní záloha kontaktů
- Jméno: ELİFE KETTAŞ DÖLEK
- E-mail: elifeket@yahoo.com
Studijní místa
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-
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Mersin, Turecko (Türkiye), 33400
- Tarsus University
-
Kontakt:
- GAMZE BOZKUL
- E-mail: gamze.bozkul@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Aged 18 years or older.
- Scheduled to undergo urodynamic testing for the first time.
- Conscious, oriented, and able to cooperate.
- Able to provide written informed consent.
- Able to speak and understand Turkish.
- Without any physical or cognitive disability that would interfere with participation in the study.
Exclusion Criteria:
- Declining to participate or withdrawing from the study at any stage.
- Having chronic pain.
- Currently using anxiolytic medication.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Watching a comedy video
Participants allocated to the intervention group will watch a standardized comedy video for approximately 15 minutes on a tablet computer immediately before the urodynamic procedure under the supervision of researcher EKD. The video will be viewed in the patient's room under the supervision of a healthcare professional. The video material will be preselected by the research team and will include only scenes that do not contain violence, insults, profanity, sexual content, discrimination, or intense conflict that could evoke negative emotional responses in participants. The selection of the video content will also consider cultural appropriateness, comprehensibility, and broad audience appeal. Şahinalp (2010), in a study examining the evolution of Turkish comedy films, reported that comedy films produced during the 1970s elicited stronger humorous responses from audiences than films from later periods. Furthermore, Genç and Sarıtaş (2020) demonstrated that comedy video clips compiled |
Participants allocated to the intervention group will watch a standardized comedy video for approximately 15 minutes on a tablet computer immediately before the urodynamic procedure under the supervision of researcher EKD. The video will be viewed in the patient's room under the supervision of a healthcare professional. The video material will be preselected by the research team and will include only scenes that do not contain violence, insults, profanity, sexual content, discrimination, or intense conflict that could evoke negative emotional responses in participants. The selection of the video content will also consider cultural appropriateness, comprehensibility, and broad audience appeal. Şahinalp (2010), in a study examining the evolution of Turkish comedy films, reported that comedy films produced during the 1970s elicited stronger humorous responses from audiences than films from later periods. Furthermore, Genç and Sarıtaş (2020) demonstrated that comedy video clips compiled f |
|
Žádný zásah: Control group
Participants allocated to the control group will receive the institution's standard pre-procedural care.
As part of routine clinical practice, patients will remain in the waiting area after admission to the outpatient clinic until their scheduled procedure time.
When called to the urodynamic unit, they will receive the standard pre-procedural information routinely provided by the clinic.
Patients will then be asked to remove their clothing and assume the appropriate position for the procedure.
Urodynamic catheters will be inserted in accordance with the institutional protocol, and the examination will be performed.
During the procedure, bladder filling and voiding functions will be evaluated.
Upon completion of the examination, the catheters will be removed, and patients will be discharged according to the routine clinical protocol.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain Level
Časové okno: 12 months
|
This scale allows patients to evaluate their level of pain on a line ranging from 0 (no pain) to 10 (extremely severe pain).
It will be used to assess the intensity of pain experienced by the patients.
|
12 months
|
|
Uroflowmetric Parameters
Časové okno: 12 months
|
During the procedure, the maximum flow rate (Qmax) will be recorded.
|
12 months
|
|
Anxiety
Časové okno: 12 months
|
It is designed to assess an individual's current emotional state by asking them to respond according to how they feel at that moment.
|
12 months
|
|
Procedural Readiness
Časové okno: 12 months
|
This scale allows patients to evaluate their level of Procedural Readiness on a line ranging from 0 (no Procedural Readiness) to 10 (extremely severe Procedural Readiness).
It will be used to assess the intensity of Procedural Readiness experienced by the patients.
|
12 months
|
|
Uroflowmetric Parameters
Časové okno: 12 months
|
During the procedure, the mean flow rate (Qavg) will be recorded.
|
12 months
|
|
Uroflowmetric Parameters
Časové okno: 12 months
|
During the procedure, voiding time will be recorded.
|
12 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Gamze Bozkul, Tarsus University
Publikace a užitečné odkazy
Obecné publikace
- Drake MJ, Doumouchtsis SK, Hashim H, Gammie A. Fundamentals of urodynamic practice, based on International Continence Society good urodynamic practices recommendations. Neurourol Urodyn. 2018 Aug;37(S6):S50-S60. doi: 10.1002/nau.23773.
- Ozden E, Iyigun E, Bedir S. The Effect of Different Education Methods Before Invasive Urodynamics on Patients' Anxiety, Pain, Readiness and Satisfaction Levels: Randomized Controlled Clinical Trial. Pain Manag Nurs. 2024 Oct;25(5):e346-e354. doi: 10.1016/j.pmn.2024.05.003. Epub 2024 Jul 4.
- Avondstondt AM, Chiu S, Salamon C. Periurethral Lidocaine Does Not Decrease Pain After Urodynamic Testing in Women: A Double-Blinded Randomized Control Trial. Female Pelvic Med Reconstr Surg. 2021 May 1;27(5):e528-e532. doi: 10.1097/SPV.0000000000000983.
- Cici R, Yilmazel G, Dogan M, Yaytokgil M. Effect of Comedy Movies Watched During Transurethral Resection of the Prostate (TUR-P) on Vital Signs and Postoperative Pain: A Randomized Controlled Trial. Pain Pract. 2026 Mar;26(3):e70136. doi: 10.1111/papr.70136.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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