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

NCT05761340 | Completed

• 1 other identifier: Celal Bayar University
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Intramuscular Injection; Pain

Keywords

Intramuscular Injection; Pain; Helfer Skin Tap Technique; Hemodynamic parameters

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  It was implemented immediately after tetanus vaccine administration in all women

• To evaluate heart rate (per minute) immediately after tetanus vaccine in all women.

  It was implemented immediately after tetanus vaccine administration in all women

• To evaluate respiratory rate (per minute) immediately after tetanus vaccine in all women.

  It was implemented immediately after tetanus vaccine administration in all women

Study Arms (2)

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

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.

Procedure: Standard Injection technique

Interventions

Helfer skin tap injection technique PROCEDURE

1. 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

Also known as: Helfer Skin Tap Group

Helfer Skin Tap Group

Standard Injection technique PROCEDURE

1. 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

Also known as: Standard Application Group

Standard Application Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Celal Bayar University: lead

Study Sites (1)

Manisa Celal Bayar University

Manisa, 45030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aslı Karakuş Selçuk, PhD

  Manisa Celal Bayar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: March 9, 2023
• Study Start: August 30, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)