Effects of Virtual Reality and Helfer Skin Tap During Vaccination

NCT06895330 | Not Yet Recruiting

• 1 other identifier: MehmetAkifU-SBF-HEÖ-03
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to detect and compare the effects of Virtual Reality and Helfer Skin Tap methods on pain, fear, anxiety, and satisfaction during the administration of Tetanus-Diphtheria vaccine to school-aged children. This study was an experimental randomized controlled trial. The sample was included 138 children in a family health centers aged 13 years who underwent Tetanus-Diphtheria vaccine. The participants were randomly assigned to Virtual Reality, Helfer Skin Tap, and control groups. Each group included 46 children, of whom 23 were female and 23 were male. The State-Trait Anxiety Inventory, Children's Fear Scale and Visual Analog Scale were used to collect the data.

Conditions

Pain Management; Fear; Anxiety; Satisfaction

Keywords

pain; fear; anxiety; satistaction; virtual reality; helfer skin tap; vaccine

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  This scale consists of a 10-cm line (0-10 cm or 0-100 mm). The 0-line on the scale indicates "no pain," and the 10-line indicates "unbearable pain." The child is asked to mark the place that expresses the degree of pain. The distance from the point marked by the child to the 0 line is measured to determine the degree of pain. In children aged 8 and above, the Visual Analog Scale (VAS) is considered the most reliable method.

  The Visual Analog Scale (VAS) will be administered immediately prior to and immediately following the vaccination procedure.

Secondary Outcomes (3)

• State-Trait Anxiety Inventory (STAI)

  State-Trait Anxiety Inventory (STAI) will be administered immediately prior to and immediately following the vaccination procedure.

• Children Fear Scale

  Children Fear Scale will be administered immediately prior to and immediately following the vaccination procedure.

• Satisfaction level

  Satisfaction will be assessed immediately after the vaccination procedure.

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

A brief orientation regarding the use of the virtual reality headset will be provided to the children. One minute prior to the vaccination procedure, the selected video-either a roller coaster or Formula 1 experience, based on the child's preference-will be initiated through the virtual reality headset. Throughout the procedure, the children will continue to watch the video using the virtual reality headset.

Other: Virtual Reality Group

Helfer Skin Tap Group

EXPERIMENTAL

The Helfer Skin Tap technique is applied to reduce pain and muscle tension during intramuscular injection by stimulating large nerve fibers through rhythmic tapping. After determining the injection site and preparing the skin with alcohol, the area is tapped for approximately 5 seconds using the dominant hand. The syringe is then held in the dominant hand while a "V" shape is formed with the non-dominant hand to tap the skin firmly three times. On the count of three, the needle is inserted at a 90° angle. After aspiration, the medication is injected slowly while gentle tapping continues to maintain muscle relaxation. The procedure concludes with simultaneous needle withdrawal and a final V-shaped tap to minimize discomfort.

Other: Helfer Skin Tap Group

Interventions

Virtual Reality Group OTHER

A brief orientation regarding the use of the virtual reality headset will be provided to the children. One minute prior to the vaccination procedure, the selected video-either a roller coaster or Formula 1 experience, based on the child's preference-will be initiated through the virtual reality headset. Throughout the procedure, the children will continue to watch the video using the virtual reality headset.

Virtual Reality Group

Helfer Skin Tap Group OTHER

The Helfer Skin Tap technique is applied to reduce pain and muscle tension during intramuscular injection by stimulating large nerve fibers through rhythmic tapping. After determining the injection site and preparing the skin with alcohol, the area is tapped for approximately 5 seconds using the dominant hand. The syringe is then held in the dominant hand while a "V" shape is formed with the non-dominant hand to tap the skin firmly three times. On the count of three, the needle is inserted at a 90° angle. After aspiration, the medication is injected slowly while gentle tapping continues to maintain muscle relaxation. The procedure concludes with simultaneous needle withdrawal and a final V-shaped tap to minimize discomfort.

Helfer Skin Tap Group

Eligibility Criteria

• Age: 13 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years
• being conscious (with the ability to communicate)

You may not qualify if:

• having a physical and psychological condition
• taking any analgesics, sedatives, or anticonvulsants in the past 24 hours
• having chronic or life-threatening disease
• refusing the virtual reality or helfer skin tap technique intervention during vaccine injection.

Sponsors & Collaborators

• Mehmet Akif Ersoy University: lead

Study Sites (1)

Mehmet Akif Ersoy University

Burdur, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Anxiety Disorders; Personal Satisfaction; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Officials

• Nihal TASKIRAN

  Aydin Adnan Menderes University

  STUDY CHAIR

• Seyma KISLALI TAS

  Manisa Soma Family Health Center

  STUDY CHAIR

Central Study Contacts

Hatice ERDEM ÖNDER

CONTACT

+905079741125; honder@mehmetakif.edu.tr

Dilek SARI

CONTACT

+90 232 311 5569; dilsari@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The participants were randomly assigned to Virtual reality, Helfer skin tap, and control groups.

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: May 3, 2025
• Primary Completion: December 3, 2025
• Study Completion: April 15, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)