Pregnant Women
Conditions
Keywords
immunization, pain, hemodynamic parameters, pregnant women, local cold application, helfer skin tap tecnique
Brief summary
The purpose of this study is to investigate the effect of local cold application using the Helfer Skin Tap Technique on pain levels during the intramuscular injection of the tetanus vaccine in pregnant women. The study will also record vital signs, which are among the physiological effects of pain.
Detailed description
This randomized controlled study aims to evaluate the effects of the Helfer Skin Tap Technique and local cold application on pain intensity and hemodynamic parameters during intramuscular tetanus vaccination in pregnant women. The sample size will be calculated prior to data collection using the G\*Power 3.1.9.2 software. Pregnant women included in the sample will be randomly assigned to three groups using the Research Randomizer program. According to the randomization: Group 1 (intervention) will receive the tetanus vaccine using the Helfer Skin Tap Technique, Group 2 (intervention) will receive the vaccine with local cold application, Group 3 (control) will receive the standard IM injection without additional intervention. Data will be collected from pregnant women who are followed by Soma No. 5 Family Health Center and who apply to the institution for tetanus vaccination during pregnancy. The data collection tools include a Personal Information Form, Numeric Pain Rating Scale (NPRS), the Helfer Skin Tap IM Injection Procedure Guideline, Cold Compress Gel IM Injection Guideline, and Standard IM Injection Guideline. Injections will be administered to participants in all groups according to the respective guidelines. Vital signs (such as heart rate, blood pressure, peripheral oxygen saturation (%), and respiratory rate) will be measured before injection, immediately after injection, and 15 minutes post-injection. Pain levels will be assessed immediately and at the 15th minute following the injection. Additionally, to evaluate the longer-term effects of pain, participants will be contacted via a follow-up link and asked to report their pain levels at the 24th and 48th hours after vaccination.
Interventions
BEHAVIORALHelfer Skin Tap Tecnique
In the first phase of the study, pregnant women who agree to participate and meet the sampling criteria will be informed about the study, and their written and verbal consents will be obtained. Then, the "Individual Identification Form" will be completed. In the second phase, the vital signs of the pregnant women will be measured by the nurse involved in the study. Following this, tetanus vaccination will be administered to the pregnant women in the intervention group using the Helfer Skin Tap technique in accordance with the "Helfer Skin Tap IM Injection Procedure Guideline". In the third phase of the study, pain will be assessed using the Numerical Pain Scale immediately after the procedure and 15 minutes later by the nurse, and the vital signs of the pregnant women will be measured again. To evaluate the long-term effects of pain, participants will be contacted via a link, and pain assessments will be conducted at the 24th and 48th hours following the vaccination.
BEHAVIORALLocal Cold Application
In the first phase of the study, pregnant women who agree to participate and meet the sampling criteria will be informed about the study, and their written and verbal consents will be obtained. Then, the "Individual Identification Form" will be completed. In the second phase, the vital signs of the pregnant women will be measured by the nurse involved in the study. Subsequently, tetanus vaccination will be administered to the pregnant women in the intervention group using a cold compress gel, based on the "Cold Compress Gel IM Injection Procedure Guideline" developed in line with the relevant literature. In the third phase of the study, pain will be assessed using the Numerical Pain Scale immediately after the procedure and 15 minutes later by nurse, and the vital signs of the pregnant women will be measured again. Pain assessment will be repeated at the 24th and 48th hours following the vaccination.
Sponsors
Celal Bayar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
In this study, participants were randomly assigned to groups in order to evaluate the effectiveness of nursing interventions. Randomization was carried out by creating 3 sets, each containing 30 unique numbers ranging from 1 to 90. Each set was used for group assignments. The randomization process was organized sequentially with non-repeating numbers across the sets. Participants were assigned to groups according to the order of each set. The randomization process was performed using the Research Randomizer program.
Intervention model description
The pregnant women to be assigned to the group will be determined using the Research Randomizer program. In the first phase of the study, pregnant women who accept to participate and meet the sample selection criteria will be informed about the study, and written and verbal consent will be obtained. Then, before the intramuscular tetanus vaccination, a "Personal Information Form" will be filled out by one of the researchers, the institution nurse, using a face-to-face interview technique. In the second phase, the nurse will measure the vital signs of the pregnant women. Then, the vaccine will be administered using the method used. In the third phase of the study, pain assessment will be made using the NPS immediately after the procedure and 15 minutes later, and the vital signs of the pregnant women will be measured. Pain evaluation will be conducted 24 and 48 hours after the vaccination.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
Pregnant women who meet the following criteria will be included in the study: * Over the age of 18, * Scheduled to receive a tetanus vaccine, * Able to speak and communicate in Turkish, * Willing to participate in the study, * Not experiencing any pain for any reason prior to the injection.
Exclusion criteria
Pregnant women who meet any of the following criteria will be excluded from the study: * Under the age of 18, * Received a tetanus vaccine for reasons other than pregnancy, * Received a vaccine other than tetanus, * Experiencing pain for any reason prior to the vaccine, * Have circulatory disorders or peripheral vascular disease, * Have bleeding or clotting disorders, * Have a local infection, * Used painkillers at least 6 hours prior to the procedure, * Underwent a painful procedure within the last hour, * Have cold sensitivity, * Have cognitive or psychological issues.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Individual Identification Form | It was implemented on the first day of the study. | The "Individual Identification Form," which includes the sociodemographic characteristics of the pregnant women, was developed by the researchers based on the relevant literature. The form consists of 9 questions. |
| Use of a numerical pain scale in the assessment of injection-related pain | immediately after the injection, 15 minutes later, and at the 24th and 48th hours | Pain assessment related to the injection in pregnant women will be conducted using the Numerical Pain Scale immediately after the injection, 15 minutes later, and at the 24th and 48th hours. It is based on the principle that patients circle the number representing the amount of pain they experience on a 10 cm horizontal scale, with "No Pain" written at the far left and "Severe Pain" at the far right. When evaluating pain intensity, a score of 0 indicates "No pain," 1-3 points indicate "Mild pain," 4-6 points indicate "Moderate pain," and 7-10 points indicate "Severe pain." |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring the systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) of the pregnant women | before the injection, immediately after the injection, and 15 minutes after the injection | In the study, systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg), which is one of the physiological effects of pain, will be recorded three times. |
| Monitoring the heart rate (per minute) of the pregnant women | before the injection, immediately after the injection, and 15 minutes after the injection | In the study, heart rate (per minute), which is one of the physiological effects of pain, will be recorded three times. |
| Monitoring the respiratory rate (per minute) of the pregnant women | before the injection, immediately after the injection, and 15 minutes after the injection | In the study, respiratory rate (per minute), which is one of the physiological effects of pain, will be recorded three times. |
| Monitoring the peripheral oxygen saturation (%) of the pregnant women | before the injection, immediately after the injection, and 15 minutes after the injection | In the study, peripheral oxygen saturation (%), which is one of the physiological effects of pain, will be recorded three times. |
Countries
Turkey (Türkiye)
Contacts
CONTACTSevgi PAKİŞ ÇETİN, Asst. Prof.
PRINCIPAL_INVESTIGATORSevgi Pakiş Çetin, Asst. Prof.
Celal Bayar University
Outcome results
None listed