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Effect of Watching a Comedy Video on Anxiety, Pain, Procedural Readiness, and Uroflowmetric Parameters in Patients Undergoing Urodynamic Testing

23. července 2026 aktualizováno: Gamze BOZKUL, Tarsus University

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

Zatím nenabíráme

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

Intervenční

Zápis (Odhadovaný)

68

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

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

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

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

Zde najdete lidi a organizace zapojené do této studie.

Spolupracovníci

Vyšetřovatelé

  • Ředitel studie: Gamze Bozkul, Tarsus University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

1. srpna 2027

Termíny zápisu do studia

První předloženo

19. července 2026

První předloženo, které splnilo kritéria kontroly kvality

23. července 2026

První zveřejněno (Aktuální)

27. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

27. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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