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Investigation of the Effect of Jet Lidocaine and Ice Application on Pain and Anxiety in Peripheral Venous Catheterization (PVC). The research will be carried out experimentally with a single group post-test method. The universe of the research; Between June-December 2022, all patients who need peripheral venous catheterization (PVK) for the treatment plan will be formed in the internal clinics of Gümüşhane State Hospital. The sample of the study will consist of 80 patients from the defined population who meet the inclusion criteria. Power analysis was used to determine the number of samples in the study. First of all, patients who are hospitalized in the internal clinics of Gümüşhane State Hospital and who meet the inclusion criteria will be determined. Written and verbal consent will be obtained for their participation by giving information about the research. PVK application will be applied to all patients by the same investigator. Each patient will create their own control group in order to control individual differences in pain and anxiety. In the study consisting of two intervention and a control group; The same patients will be included in the intervention groups and the control group. Randomization will be done to determine the order of intervention to be applied to the patients. The interventions for each patient will be numbered by the researcher and the order of procedure will be determined by drawing lots. After the cephalic vein for the first attempt is randomly determined, the other extremity vein will be used while performing consecutive PVC applications. To control the research in terms of bias; During the data collection phase, help will be taken from the clinical nurse who takes care of the patient. The nurse, who does not know which intervention is applied, will be asked to evaluate the patient's pain and anxiety. In this respect, the research will be considered single-blind.
This study was planned as a randomized controlled, single-blind experiment. The research will be carried out in the internal clinics of Gümüşhane State Hospital. Internal clinics were preferred because patients hospitalized in surgical clinics experienced intense pain and anxiety due to surgical operations. The universe of the research; All patients who are hospitalized in the relevant clinics within the specified time period and who need to apply PVC for the treatment plan will be formed.
The sample of the research; It will consist of 80 patients who are hospitalized in internal clinics, who need PVC for diagnosis or treatment, and who meet the research criteria. Power analysis was used to determine the number of samples in the study.The data of the research; Patient Information Form will be collected using the Visual Analog Scale for Pain (VAS-P), Visual Analog Scale for Anxiety (VAS-A), Wong-Baker Faces Pain Rating Scale. Nursing Intervention: The research will be conducted experimentally with a single group post-test method. First of all, patients who meet the criteria for inclusion in the study will be determined, and written and verbal consent will be obtained for their participation by giving information about the research. PVC application will be applied to all patients by the same investigator. Each patient will create their own control group in order to control individual differences in pain and anxiety. In the study consisting of two intervention and a control group; The same patients will be included in the intervention groups and the control group. Randomization will be done to determine the order of intervention to be applied to the patients. Interventions will be numbered for each patient and the order of procedure will be determined by drawing lots. After the cephalic vein for the first attempt is randomly determined, the other extremity vein will be used while performing consecutive PVC applications. To control the research in terms of bias; During the data collection phase, help will be taken from the clinical nurse who takes care of the patient. The nurse, who does not know which intervention is applied, will be asked to evaluate the patient's pain and anxiety. In this respect, the research will be considered single-blind.
Intervention group-I (Jet lidocaine will be applied before PVC and PVC will be performed 3 minutes later) Intervention group-II (Ice application will be made for 1 minute before PVC and then PVC will be performed) It will be named as the control group (Standard PVC procedure will be applied)
Process steps
Control group PVC Application Steps
Intervention group-I PVC Application Steps
Initiative Group-II PVC Application Steps
Independent variables:
0.3 ml Jet lidocaine application before peripheral venous catheterization
1 minute ice application before peripheral venous catheterization
Control variables:
Peripheral venous catheterization site (Cephalic vein), Catheter diameter and length (22 G)
Evaluation of data: The data will be evaluated in the SPSS (Statistical Package for Social Sciences for Windows, Version 22.0) package program. In the evaluation of the data, the statistical significance value will be accepted as 0.05, the Type 1 error will be kept at 5% and the evaluation will be made with a 95% confidence interval
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jet lidocaine group | Experimental | Jet lidocaine will be applied before PVC and PVC will be performed 3 minutes later. |
|
| Ice group | Experimental | Ice will be applied for 1 minute before PVC, and then PVC will be performed. |
|
| Control group | Active Comparator | Standard PVC procedure will be applied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jet lidocaine | Drug | Jet lidocaine will be applied before PVC and PVC will be performed 3 minutes later. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale for Pain (VAS-P) | It is a scale used to evaluate the severity of pain. It is a 100 mm ruler with painlessness at one end and the most severe pain at the other. "0" denotes painlessness, and "100" denotes the most severe pain.A low score from the scale indicates that the application is beneficial. | Within 1 minute after PVC application |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale for Anxiety (VAS-A) | VAS-A; It consists of a continuous horizontal line 0-100 mm long. "0" represents I am not nervous at all, while "100" represents I am extremely nervous. Participants indicate their level of anxiety by specifying a position between the two extremes.A low score from the scale indicates that the application is beneficial. | Within 1 minute after PVC application |
| Measure | Description | Time Frame |
|---|---|---|
| Wong-Baker Faces Pain Rating Scale | The revised version of the scale is widely used in the assessment of pain severity in the adult and pediatric population. The scale includes visual representations of six facial expressions that increasingly represent pain intensity. Pain score is given according to the numerical values given to the faces in the scale. The lowest score is "0" and the highest score is "10". As the score obtained from the scale increases, the severity of pain increases, and as the score decreases, the severity decreases. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esra Aydın | esraaydin@gumushane.edu.tr-0456 2331149 | Principal Investigator |
| Gülçin Avşar | gulcin.avsar@atauni.edu.tr-0 442 2311584 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ataturk University Faculty of Nursing | Erzurum | Centre | 25100 | Turkey (Türkiye) | ||
| Gumushane Health Services Vocational School |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007053 | Ice |
| ID | Term |
|---|---|
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 |
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In the study, 80 individuals, including 2 experimental and 1 control group, were included in the study.
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To control the research in terms of bias; During the data collection phase, help will be taken from the clinical nurse who takes care of the patient. The nurse, who does not know which intervention is applied, will be asked to evaluate the patient's pain and anxiety. In this respect, the research will be considered single-blind.
| Ice | Combination Product | Ice will be applied for 1 minute before PVC, and then PVC will be performed. |
|
|
| Standard PVC procedure | Other | Standard PVC procedure will be applied |
|
|
| While performing the PVC application |
| Gümüşhane |
| Centre |
| 29100 |
| Turkey (Türkiye) |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D014887 | Weather |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |