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It is to examine the effect of virtual reality and ice application on the pain level due to femoral sheath extraction.
After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (virtual reality glasses application, ice application and control group).
Randomization: Since the number of male and female patients was wanted to be kept equal, simple randomization would not be possible, so the stratified randomization method was used.
Patients were assigned to groups in equal numbers according to their femoral sheath sizes. In our clinic, size 6 and 7 femoral sheaths are applied to male patients, and number 6 femoral sheaths are applied to female patients. Male patients were assigned to equal groups according to femoral sheath size 6 and 7.
Since PCI is not performed in our clinic on weekends except for emergencies, data were collected during working hours during a five-day weekday period.
The pain level of the patients was evaluated using a numerical rating scale;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Glasses Gruop | Experimental | The procedure was tested for five minutes, one hour before application, to evaluate the patients' compliance and to detect any possible problems after wearing the glasses. In patients who did not experience any problems after the test, glasses were put on the patient just before the femoral sheath and remained on for 20 minutes. |
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| Ice Application Group | Experimental | Before taking the femoral sheath, the researcher applied cold to the area where the femoral sheath was located with an ice pack for 20 minutes. A femoral sheath was performed immediately after the ice bag was removed. |
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| Control Group | Other | The general procedure of the clinic was applied to the control group. Femoral sheath was removed without any invasive procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Glasses | Other | Preparation Stage of Virtual Glasses: A 20-minute video consisting of nature scenes shot with a 360-degree camera was selected by the researchers from YouTube. Permission was obtained from the person who created the video. For the selection of music, both the music that is good for diseases were examined in the literature and an expert opinion was taken from a faculty member (Phd, assistant professor) working at the Faculty of Music and Fine Arts of a university. The music used in the video was created with works selected from the Hüseyni maqam. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores: Numerical rating scale | The Numeric Rating Scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a min:0-max:10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable" (10). This scale is a valid and reliable scale developed to determine the pain level of patients. The numerical rating scale simplifies the description of the pain level by the patient and makes it easier for the monitoring nurse to record the patient's pain rating. That the pain increases as the score increases, and then the patient verbally tells the numerical value of the pain intensity he/she feels. Pain score was measured before femoral sheath removal (time 1), and, during femoral sheath removal (2nd time),and, immediately after femoral sheath removal (3rd time), and 30 minutes after femoral sheath removal (4th time), and1 hour after femoral sheath removal (5th time). | "through study completion, an average of 1 year". |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological parameter | Vital parameters (Pulse rate measured in minutes) of the patients were evaluated Pulse rate was measured before femoral sheath removal (time 1) Pulse rate was measured during femoral sheath removal (2nd time) Pulse rate was measured immediately after femoral sheath removal (3rd time) Pulse rate was measured 30 minutes after femoral sheath removal (4th time) Pulse rate was measured 1 hour after femoral sheath removal (5th time |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire | The patients' opinions regarding the application of ice and virtual reality glasses were evaluated. | "through study completion, an average of 1 year". |
Inclusion Criteria:
Exclusion Criteria:
There were equal numbers of men and women in all three groups
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| Name | Affiliation | Role |
|---|---|---|
| Eylem TopbaÅŸ, Phd | Amasya University Faculty of Health Science | Study Director |
| Gökhan KESKİN, Phd | Amasya University Faculty of Medical Science | Study Director |
| Aycan SOYLU, Msc | Amasya University Instutue of Health Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amasya University İnstitute of Health Sciences | Amasya | Merkez | 05100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15297952 | Result | Wang HL, Keck JF. Foot and hand massage as an intervention for postoperative pain. Pain Manag Nurs. 2004 Jun;5(2):59-65. doi: 10.1016/j.pmn.2004.01.002. | |
| 9145556 | Result | Paice JA, Cohen FL. Validity of a verbally administered numeric rating scale to measure cancer pain intensity. Cancer Nurs. 1997 Apr;20(2):88-93. doi: 10.1097/00002820-199704000-00002. |
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starting in December 2025
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
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It is a randomized controlled, single-blind, experimental study. Participants were assigned to three groups: intervention (virtual reality group and ice group) and control group.
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It is a randomized controlled, single-blind, experimental study.
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| Ice Application Group | Other | Features of the ice and ice bag used for patients in ice application; Ice cubes with dimensions of 9.5 x 26 x 3.5 cm were used. The ice bag is made of cotton and polyester coated fabric and is easily bendable. In this way, the ice bag was ensured to fit properly to the patient's femoral region. It is reusable and heat insulated. The procedure was carried out by following the cold application step protocol created by the researchers using the literature. |
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| Control Group | Other | They continued to receive their routine treatment and care. No changes were made in their routine treatment and care. |
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| "through study completion, an average of 1 year". |
| Physiological parameter | Vital parameters (respiration-rate measured in minutes) of the patients were evaluated. Respiration rate was measured before femoral sheath removal (time 1) Respiration rate was measured during femoral sheath removal (2nd time) Respiration rate was measured immediately after femoral sheath removal (3rd time) Respiration rate was measured 30 minutes after femoral sheath removal (4th time) Respiration rate was measured 1 hour after femoral sheath removal (5th time) | "through study completion, an average of 1 year". |
| Physiological parameter | Vital parameters (blood pressure-measured in mmHg) of the patients were evaluated Blood pressure was measured before femoral sheath removal (time 1) Blood pressure was measured during femoral sheath removal (2nd time) Blood pressure was measured immediately after femoral sheath removal (3rd time) Blood pressure was measured 30 minutes after femoral sheath removal (4th time) Blood pressure was measured 1 hour after femoral sheath removal (5th time) | "through study completion, an average of 1 year". |
| Physiological parameter | Vital parameters (body temperature measured in degrees Centigrant) of the patients were evaluated Body temperature was measured before femoral sheath removal (time 1) Body temperature was measured during femoral sheath removal (2nd time) Body temperature was measured immediately after femoral sheath removal (3rd time) Body temperature was measured 30 minutes after femoral sheath removal (4th time) Body temperature was measured 1 hour after femoral sheath removal (5th time) | "through study completion, an average of 1 year". |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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