Effect of Helfer Skin Tap and Cold Application on Pain and Hemodynamics During Vaccination
ConditionPregnant Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorCelal Bayar University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over the age of 18,
Scheduled to receive a tetanus vaccine,
Able to speak and communicate in Turkish,
Willing to participate in the study,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Helfer Skin Tap Tecnique
BehavioralIn 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.
Local Cold Application
BehavioralIn 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Helfer Skin Tap TecniqueExperimental treatment 1 intervention
Group C: Local Cold ApplicationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Individual Identification Form
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.
Time frame
It was implemented on the first day of the study.2
Use of a numerical pain scale in the assessment of injection-related pain
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."
Time frame
immediately after the injection, 15 minutes later, and at the 24th and 48th hoursSecondary outcomes
1
Monitoring the systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) of the pregnant women
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.
Time frame
before the injection, immediately after the injection, and 15 minutes after the injection2
Monitoring the heart rate (per minute) of the pregnant women
In the study, heart rate (per minute), which is one of the physiological effects of pain, will be recorded three times.
Time frame
before the injection, immediately after the injection, and 15 minutes after the injection3
Monitoring the respiratory rate (per minute) of the pregnant women
In the study, respiratory rate (per minute), which is one of the physiological effects of pain, will be recorded three times.
Time frame
before the injection, immediately after the injection, and 15 minutes after the injection4
Monitoring the peripheral oxygen saturation (%) of the pregnant women
In the study, peripheral oxygen saturation (%), which is one of the physiological effects of pain, will be recorded three times.
Time frame
before the injection, immediately after the injection, and 15 minutes after the injectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov