Effect of Watching a Comedy Video on Anxiety, Pain, Procedural Readiness, and Uroflowmetric Parameters in Patients Undergoing Urodynamic Testing: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Pain Level
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Participants will be allocated to the study groups by researcher EE using a simple randomization method based on a random number table. The randomization sequence will be generated using the online randomization tool available at https://www.randomizer.org/.
When patients scheduled for urodynamic testing present to the outpatient clinic, they will be screened for eligibility by researcher EKD according to the predefined inclusion criteria. Patients who meet the eligibility criteria and provide written informed consent will be enrolled in the study. Researcher EKD will then notify researcher EE, who will determine the participant's group assignment according to the pre-generated randomization sequence and communicate the allocation only to researcher EKD.
Accordingly, all researchers except EE (who is responsible for the randomization process), as well as the participants, their relatives, and the clinical staff, will remain blinded to group allocation. Outcome data will be collected
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Pain Level
Time Frame: 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.
Uroflowmetric Parameters
Time Frame: 12 months
During the procedure, the maximum flow rate (Qmax) will be recorded.
Anxiety
Time Frame: 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.
Procedural Readiness
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Gamze BOZKUL
Assistant Professor
Tarsus University