Intramuscular InjectionNCT05761340
The Effect of Helfer Skin Tap Technique During Tetanus Injection in Pregnant Women
A study testing Helfer skin tap injection technique and Standard Injection technique in people with Intramuscular Injection and Pain, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
Intramuscular (IM) vaccination administered using the right injection technique is known to cause less pain and injury. Nurses employ different approaches like applying pressure, tapping the skin, cold and hot applications for reducing the pain caused by the IM vaccine administration. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intramuscular Injection, Pain
- What is being tested?
- Helfer skin tap injection technique and Standard Injection technique
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over the age of 18
- being pregnant,
- having no infection, scar tissue, or incision, and receiving parenteral treatment in their injection area
- having no history of pain in their injection are
- applying for tetanus vaccine
- speaking Turkish
- voluntariness.
Who cannot join
- under the age of 18
- not being pregnant
- having a vaccination other than tetanus,
- having pain or a local infection prior to vaccination,
- having a circulatory disorder, peripheral vascular disease,
- cognitive and psychological problems,
- using painkillers at least 6 hours before the procedure,
- refusing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Helfer Skin Tap Technique on Pain Reduction and Hemodynamic Parameters During Tetanus Injection in Pregnant Women
Intramuscular (IM) vaccination administered using the right injection technique is known to cause less pain and injury. Nurses employ different approaches like applying pressure, tapping the skin, cold and hot applications for reducing the pain caused by the IM vaccine administration. Helfer skin tap is among the techniques that relax muscles.
The aim of the study was to determine the effect of Helfer skin tap technique on pain reduction and hemodynamic parameters during tetanus injection in pregnant women. This study was conducted on pregnant women who applied to the Family Health Center to get a tetanus vaccine. The Helfer skin tap and standard application groups each included 33 and 32 pregnant women, respectively.
Read the detailed description
In 1988, Joanne Helfer developed the "Helfer Skin Tap Technique" which is applied by touching the skin over the injection site and attempted to reduce the intramuscular injection-related pain. In this technique, after determining the injection site, nearly 15 strokes are made on the skin for almost five seconds using the fingertips of the dominant hand in order to soften the muscles. Later, the skin is cleaned with alcohol, the non-dominant hand is put in V shape and the skin is hit three times. During the third stroke, the syringe is pricked into the muscle with a 90-degree angle at the same time. Making a few taps relaxes the muscles and counting to three helps synchronizing the muscle tap and injection and standardizes the technique. Mechanical stimulation of muscle fibers of larger diameters decreases the effect of smaller, pain generating fibers. According to the gate control theory suggested by Roger Metzack and Past Wall (1965), in addition to a mechanical stimulation during an IM injection, this technique also causes distraction, which, in turn, helps reducing pain.
The study aimed to determine the effect of Helfer skin tap technique on pain reduction and hemodynamic parameters during tetanus injection in pregnant women. This study was a randomized clinical trial conducted in Manisa Soma Family Health Center in Turkey. The study was conducted with 65 pregnant women who got tetanus vaccine. Tetanus vaccine was administered using the Helfer skin tap techniques to 33 of the pregnant women and standard IM injection technique to 32 women. The pain was evaluated immediately after vaccination and hemodynamic parameters were examined before and immediately after the vaccine.
- Conditions
- Intramuscular Injection, Pain
- Being tested
- Helfer skin tap injection technique, Standard Injection technique
- Keywords
- Intramuscular Injection, Pain, Helfer Skin Tap Technique, Hemodynamic parameters
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helfer skin tap injection techniqueProcedure or surgery
Also called Helfer Skin Tap Group
- Place the patient in a seated position and open his right arm to inject into the deltoid muscle.
- After determining the injection site, use the tips of the dominant hand fingers to hit the skin (about 15 strokes) for about five seconds to soften the muscles.
- After cleaning the skin with alcohol, remove the syringe cover from the dominant hand. Make a V with the non-dominant hand and hit the skin three times.
- During the third stroke, prick the syringe into the muscle at 90 degrees angle at the same time.
- After aspiration, continue to hit the skin with the tips of the non-dominant hand fingers while injecting the drug with the dominant hand at a rate of 1 ml / 10 seconds.
- After injecting the drug, make the non-dominant hand V-shaped and hit the skin three times, pulling the syringe needle out at the same time during the third stroke
Standard Injection techniqueProcedure or surgery
Also called Standard Application Group
- Place the patient in a seated position and open his right arm to inject into the deltoid muscle area.
- After determining the injection site, prepare the skin with alcohol.
- Grasp the skin with the thumb and index finger of the non-dominant hand and prick the syringe into the muscle at a 90-degree angle.
- After aspiration, inject the drug with the dominant hand at a rate of 1 ml /10 seconds.
- Remove the syringe needle 10 seconds after the drug is consumed
| Study group | Role | What they receive |
|---|---|---|
| Helfer Skin Tap Group | Experimental | Pregnant women were vaccinated against tetanus with the Helfer skin tap technique.The pain was evaluated with Number rating scale immediately after the procedure and also hemodynamic parameters were measured before and after the vaccination. A total of 33 pregnant women completed the study in the Helfer skin tap group Receives: Procedure: Helfer skin tap injection technique |
| Standard Application Group | Experimental | Pregnant women were vaccinated against tetanus with thestandard application technique.The pain was evaluated with Number rating scale. The pain was evaluated immediately after vaccination and hemodynamic parameters were examined before and after the vaccination. A total of 32 pregnant women completed the study in the standard application group. Receives: Procedure: Standard Injection technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the pregnant women's demographics and clinical backgrounds.
Questions about the pregnant women's descriptive characteristics such as age, education and employment status, Body Mass Index, smoking status, number of children and pregnancy, having intramuscular injection and any problem after intramuscular injection, and number of tetanus injection were asked using the questionnaire.
Measured: It was implemented on the first day of the study and it took approximately 10-15 minutes to fill out the form.
To evaluate peripheral oxygen saturation (%) immediately before tetanus vaccine in all women.
Peripheral oxygen saturation (%) were evaluated immediately before tetanus vaccine administration in all women.
Measured: It was implemented immediately before tetanus vaccine administration in all women.
To evaluate heart rate (per minute) immediately before tetanus vaccine in all women.
Heart rate (per minute) were evaluated immediately before tetanus vaccine administration in all women.
Measured: It was implemented immediately before tetanus vaccine administration in all women.
To evaluate respiratory rate (per minute) immediately before tetanus vaccine in all women.
Respiratory rate (per minute) were evaluated immediately before tetanus vaccine administration in all women.
Measured: It was implemented immediately before tetanus vaccine administration in all women.
To evaluate systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) immediately before tetanus vaccine in all women.
Systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) were evaluated immediately before tetanus vaccine administration in all women.
Measured: It was implemented immediately before tetanus vaccine administration in all women.
Secondary outcomes (6)
To evaluate the pain level in the Helfer skin tap group with the Number rating scale in which 0 is defined as no pain and 10 as maximum pain.
To evaluate the pain level immediately after Tetanus vaccine that was administered using the Helfer skin tap technique with the Number rating scale in which 0 is defined as no pain and 10 as maximum pain.
Measured: It was implemented immediately after Tetanus vaccine that was administered using the Helfer skin tap techniques
To evaluate the pain level in the Standart intramuscular injection group with the Number rating scale in which 0 is defined as no pain and 10 as maximum pain.
To evaluate the pain level immediately after Tetanus vaccine that was administered using the the Standart intramuscular injection with the Number rating scale in which 0 is defined as no pain and 10 as maximum pain.
Measured: It was implemented immediately after Tetanus vaccine that was administered using the the Standart intramuscular injection techniques
To evaluate peripheral oxygen saturation (%) immediately after tetanus vaccine in all women.
Peripheral oxygen saturation (%) were evaluated immediately after tetanus vaccine administration in all women.
Measured: It was implemented immediately after tetanus vaccine administration in all women
To evaluate heart rate (per minute) immediately after tetanus vaccine in all women.
Heart rate (per minute) were evaluated immediately after tetanus vaccine administration in all women.
Measured: It was implemented immediately after tetanus vaccine administration in all women
To evaluate respiratory rate (per minute) immediately after tetanus vaccine in all women.
Respiratory rate (per minute) were evaluated immediately after tetanus vaccine administration in all women.
Measured: It was implemented immediately after tetanus vaccine administration in all women
To evaluate systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) immediately after tetanus vaccine in all women.
Systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) were evaluated immediately after tetanus vaccine administration in all women.
Measured: It was implemented immediately after tetanus vaccine administration in all women
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start30 Aug 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intramuscular InjectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aslı Karakuş Selçuk, PhD, Principal investigator, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761340
- Sponsor's protocol ID
- Celal Bayar University
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Helfer Skin Tap Technique on Pain Reduction and Hemodynamic Parameters During Tetanus Injection in Pregnant Women
- ClinicalTrials.gov ID
- NCT05761340
- Acronym / sponsor ID
- Celal Bayar University
- Conditions
- Intramuscular Injection, Pain
- Keywords
- Intramuscular Injection, Pain, Helfer Skin Tap Technique, Hemodynamic parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intramuscular (IM) vaccination administered using the right injection technique is known to cause less pain and injury. Nurses employ different approaches like applying pressure, tapping the skin, cold and hot applications for reducing the pain caused by the IM vaccine administration. Helfer skin tap is among the techniques that relax muscles.
The aim of the study was to determine the effect of Helfer skin tap technique on pain reduction and hemodynamic parameters during tetanus injection in pregnant women. This study was conducted on pregnant women who applied to the Family Health Center to get a tetanus vaccine. The Helfer skin tap and standard application groups each included 33 and 32 pregnant women, respectively.
Detailed description
In 1988, Joanne Helfer developed the "Helfer Skin Tap Technique" which is applied by touching the skin over the injection site and attempted to reduce the intramuscular injection-related pain. In this technique, after determining the injection site, nearly 15 strokes are made on the skin for almost five seconds using the fingertips of the dominant hand in order to soften the muscles. Later, the skin is cleaned with alcohol, the non-dominant hand is put in V shape and the skin is hit three times. During the third stroke, the syringe is pricked into the muscle with a 90-degree angle at the same time. Making a few taps relaxes the muscles and counting to three helps synchronizing the muscle tap and injection and standardizes the technique. Mechanical stimulation of muscle fibers of larger diameters decreases the effect of smaller, pain generating fibers. According to the gate control theory suggested by Roger Metzack and Past Wall (1965), in addition to a mechanical stimulation during an IM injection, this technique also causes distraction, which, in turn, helps reducing pain.
The study aimed to determine the effect of Helfer skin tap technique on pain reduction and hemodynamic parameters during tetanus injection in pregnant women. This study was a randomized clinical trial conducted in Manisa Soma Family Health Center in Turkey. The study was conducted with 65 pregnant women who got tetanus vaccine. Tetanus vaccine was administered using the Helfer skin tap techniques to 33 of the pregnant women and standard IM injection technique to 32 women. The pain was evaluated immediately after vaccination and hemodynamic parameters were examined before and immediately after the vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Helfer Skin Tap Group | Experimental | Procedure: Helfer skin tap injection techniquePregnant women were vaccinated against tetanus with the Helfer skin tap technique.The pain was evaluated with Number rating scale immediately after the procedure and also hemodynamic parameters were measured before and after the vaccination. A total of 33 pregnant women completed the study in the Helfer skin tap group |
| Standard Application Group | Experimental | Procedure: Standard Injection techniquePregnant women were vaccinated against tetanus with thestandard application technique.The pain was evaluated with Number rating scale. The pain was evaluated immediately after vaccination and hemodynamic parameters were examined before and after the vaccination. A total of 32 pregnant women completed the study in the standard application group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- over the age of 18
- being pregnant,
- having no infection, scar tissue, or incision, and receiving parenteral treatment in their injection area
- having no history of pain in their injection are
- applying for tetanus vaccine
Key exclusion criteria (8 listed)
- under the age of 18
- not being pregnant
- having a vaccination other than tetanus,
- having pain or a local infection prior to vaccination,
- having a circulatory disorder, peripheral vascular disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helfer skin tap injection techniqueAlso: Helfer Skin Tap Group1. Place the patient in a seated position and open his right arm to inject into the deltoid muscle. 2. After determining the injection site, use the tips of the dominant hand fingers to hit the skin (about 15 strokes) for about five seconds to soften the muscles. 3. After cleaning the skin with alcohol, remove the syringe cover from the dominant hand. Make a V with the non-dominant hand and hit the skin three times. 4. During the third stroke, prick the syringe into the muscle at 90 degrees angle at the same time. 5. After aspiration, continue to hit the skin with the tips of the non-dominant hand fingers while injecting the drug with the dominant hand at a rate of 1 ml / 10 seconds. 6. After injecting the drug, make the non-dominant hand V-shaped and hit the skin three times, pulling the syringe needle out at the same time during the third stroke | Procedure or surgery | Helfer Skin Tap Group |
| Standard Injection techniqueAlso: Standard Application Group1. Place the patient in a seated position and open his right arm to inject into the deltoid muscle area. 2. After determining the injection site, prepare the skin with alcohol. 3. Grasp the skin with the thumb and index finger of the non-dominant hand and prick the syringe into the muscle at a 90-degree angle. 4. After aspiration, inject the drug with the dominant hand at a rate of 1 ml /10 seconds. 5. Remove the syringe needle 10 seconds after the drug is consumed | Procedure or surgery | Standard Application Group |
Primary outcome
Description of the pregnant women's demographics and clinical backgrounds.
Time frame: It was implemented on the first day of the study and it took approximately 10-15 minutes to fill out the form.
Questions about the pregnant women's descriptive characteristics such as age, education and employment status, Body Mass Index, smoking status, number of children and pregnancy, having intramuscular injection and any problem after intramuscular injection, and number of tetanus injection were asked using the questionnaire.
To evaluate peripheral oxygen saturation (%) immediately before tetanus vaccine in all women.
Time frame: It was implemented immediately before tetanus vaccine administration in all women.
Peripheral oxygen saturation (%) were evaluated immediately before tetanus vaccine administration in all women.
To evaluate heart rate (per minute) immediately before tetanus vaccine in all women.
Time frame: It was implemented immediately before tetanus vaccine administration in all women.
Heart rate (per minute) were evaluated immediately before tetanus vaccine administration in all women.
To evaluate respiratory rate (per minute) immediately before tetanus vaccine in all women.
Time frame: It was implemented immediately before tetanus vaccine administration in all women.
Respiratory rate (per minute) were evaluated immediately before tetanus vaccine administration in all women.
To evaluate systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) immediately before tetanus vaccine in all women.
Time frame: It was implemented immediately before tetanus vaccine administration in all women.
Systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) were evaluated immediately before tetanus vaccine administration in all women.
6 secondary outcomes
To evaluate the pain level in the Helfer skin tap group with the Number rating scale in which 0 is defined as no pain and 10 as maximum pain.
Time frame: It was implemented immediately after Tetanus vaccine that was administered using the Helfer skin tap techniques
To evaluate the pain level in the Standart intramuscular injection group with the Number rating scale in which 0 is defined as no pain and 10 as maximum pain.
Time frame: It was implemented immediately after Tetanus vaccine that was administered using the the Standart intramuscular injection techniques
To evaluate peripheral oxygen saturation (%) immediately after tetanus vaccine in all women.
Time frame: It was implemented immediately after tetanus vaccine administration in all women
To evaluate heart rate (per minute) immediately after tetanus vaccine in all women.
Time frame: It was implemented immediately after tetanus vaccine administration in all women
To evaluate respiratory rate (per minute) immediately after tetanus vaccine in all women.
Time frame: It was implemented immediately after tetanus vaccine administration in all women
To evaluate systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) immediately after tetanus vaccine in all women.
Time frame: It was implemented immediately after tetanus vaccine administration in all women
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslı Karakuş Selçuk, PhD principal investigator
Manisa Celal Bayar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helfer skin tap injection technique and Standard Injection technique in people with Intramuscular Injection and Pain, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the pregnant women's demographics and clinical backgrounds. (time frame: It was implemented on the first day of the study and it took approximately 10-15 minutes to fill out the form.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.