search
Back to results

The Effect of Helfer Skin Tap Technique During Tetanus Injection in Pregnant Women

Primary Purpose

Intramuscular Injection, Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Helfer skin tap injection technique
Standard Injection technique
Sponsored by
Celal Bayar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intramuscular Injection focused on measuring Intramuscular Injection, Pain, Helfer Skin Tap Technique, Hemodynamic parameters

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Manisa Celal Bayar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Helfer Skin Tap Group

Standard Application Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 25, 2023
Last Updated
February 27, 2023
Sponsor
Celal Bayar University
search

1. Study Identification

Unique Protocol Identification Number
NCT05761340
Brief Title
The Effect of Helfer Skin Tap Technique During Tetanus Injection in Pregnant Women
Official Title
The Effect of Helfer Skin Tap Technique on Pain Reduction and Hemodynamic Parameters During Tetanus Injection in Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celal Bayar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intramuscular Injection, Pain
Keywords
Intramuscular Injection, Pain, Helfer Skin Tap Technique, Hemodynamic parameters

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized clinical trial
Masking
ParticipantInvestigator
Masking Description
Pregnant women meeting the inclusion criteria were assigned to the Helfer skin tap and standard application groups by a computer-based random number generator. The numbers in set 1 were taken to the Helfer skin tap group and the numbers in set 2 to the standard application group by lot method.
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Helfer Skin Tap Group
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Application Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Helfer skin tap injection technique
Other Intervention Name(s)
Helfer Skin Tap Group
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Standard Injection technique
Other Intervention Name(s)
Standard Application Group
Intervention Description
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
Primary Outcome Measure Information:
Title
Description of the pregnant women's demographics and clinical backgrounds.
Description
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.
Time Frame
It was implemented on the first day of the study and it took approximately 10-15 minutes to fill out the form.
Title
To evaluate peripheral oxygen saturation (%) immediately before tetanus vaccine in all women.
Description
Peripheral oxygen saturation (%) were evaluated immediately before tetanus vaccine administration in all women.
Time Frame
It was implemented immediately before tetanus vaccine administration in all women.
Title
To evaluate heart rate (per minute) immediately before tetanus vaccine in all women.
Description
Heart rate (per minute) were evaluated immediately before tetanus vaccine administration in all women.
Time Frame
It was implemented immediately before tetanus vaccine administration in all women.
Title
To evaluate respiratory rate (per minute) immediately before tetanus vaccine in all women.
Description
Respiratory rate (per minute) were evaluated immediately before tetanus vaccine administration in all women.
Time Frame
It was implemented immediately before tetanus vaccine administration in all women.
Title
To evaluate systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) immediately before tetanus vaccine in all women.
Description
Systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) were evaluated immediately before tetanus vaccine administration in all women.
Time Frame
It was implemented immediately before tetanus vaccine administration in all women.
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
It was implemented immediately after Tetanus vaccine that was administered using the Helfer skin tap techniques
Title
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.
Description
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.
Time Frame
It was implemented immediately after Tetanus vaccine that was administered using the the Standart intramuscular injection techniques
Title
To evaluate peripheral oxygen saturation (%) immediately after tetanus vaccine in all women.
Description
Peripheral oxygen saturation (%) were evaluated immediately after tetanus vaccine administration in all women.
Time Frame
It was implemented immediately after tetanus vaccine administration in all women
Title
To evaluate heart rate (per minute) immediately after tetanus vaccine in all women.
Description
Heart rate (per minute) were evaluated immediately after tetanus vaccine administration in all women.
Time Frame
It was implemented immediately after tetanus vaccine administration in all women
Title
To evaluate respiratory rate (per minute) immediately after tetanus vaccine in all women.
Description
Respiratory rate (per minute) were evaluated immediately after tetanus vaccine administration in all women.
Time Frame
It was implemented immediately after tetanus vaccine administration in all women
Title
To evaluate systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) immediately after tetanus vaccine in all women.
Description
Systolic blood pressure (mm/Hg) and diastolic blood pressure (mm/Hg) were evaluated immediately after tetanus vaccine administration in all women.
Time Frame
It was implemented immediately after tetanus vaccine administration in all women

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aslı Karakuş Selçuk, PhD
Organizational Affiliation
Manisa Celal Bayar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manisa Celal Bayar University
City
Manisa
ZIP/Postal Code
45030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Helfer Skin Tap Technique During Tetanus Injection in Pregnant Women

We'll reach out to this number within 24 hrs