Effects of Virtual Reality and Helfer Skin Tap During Vaccination

NCT ID: NCT06895330

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-03
• Study Completion Date: 2026-04-15

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.

Detailed Description

This research aims to determine 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.

The following hypotheses were determined for the present study. Hypothesis 1. Virtual Reality is effective in reducing pain, fear and anxiety of children and increasing satisfaction during Tetanus-Diphtheria vaccine injection.

Hypothesis 2. Helfer Skin Tap is effective in reducing pain, fear and anxiety of children and increasing satisfaction during Tetanus-Diphtheria vaccine injection.

Hypothesis 3. Virtual Reality is more effective than Helfer Skin Tap in reducing pain, fear and anxiety of children and increasing satisfaction during Tetanus-Diphtheria vaccine injection.

This prospective, randomized controlled study will be conducted in a family health center in Manisa, Turkey, between May 2025 and December 2025. A parallel-group design will be employed, consisting of three arms: Virtual Reality, Helfer Skin Tap, and a control group. The study protocol will be guided by the Consolidated Standards of Reporting Trials (CONSORT) checklist. All procedures will be performed by the same nurse at the designated family health center to ensure standardization.

Children aged 13 years who will undergo tetanus-diphtheria vaccination will be considered eligible for inclusion. Inclusion criteria will include being 13 years of age and conscious (able to communicate). Exclusion criteria will encompass the presence of any physical or psychological condition, the use of analgesics, sedatives, or anticonvulsants within the preceding 24 hours, diagnosis of any chronic or life-threatening disease, and refusal to participate in the Virtual Reality or Helfer Skin Tap interventions during vaccination.

The sample size for the research was determined using G*power 3.0.8 software, and power analysis was conducted. With a 5% error rate, 80% power, and a medium effect size of 0.25 for the 3 groups with 2 repeated factors, it was calculated that 46 children should be taken for each group (Ellis, 2010). Accordingly, the total sample will consist of 138 children.

Eligible children presenting for tetanus vaccination will be randomly assigned to one of the three groups: Virtual Reality, Helfer Skin Tap, or control (conventional injection technique). To control for potential gender-related effects, children will first be stratified by gender and subsequently randomized into the groups using block randomization.

For randomization and to minimize potential bias, group names (Virtual Reality, Helfer Skin Tap, Control) will be written on identical papers and placed into two separate boxes-pink for females and blue for males. Immediately prior to vaccination, each child will draw a paper from the corresponding box to determine their group allocation. This procedure will ensure gender balance across the groups.

Each group will comprise 46 children, with an equal distribution of 23 females and 23 males.

Conditions

Pain Management; Fear; Anxiety; Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Virtual Reality Group

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.

Group Type: EXPERIMENTAL

Virtual Reality Group

Intervention Type: 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.

Helfer Skin Tap Group

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.

Group Type: EXPERIMENTAL

Helfer Skin Tap Group

Intervention Type: 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.

Interventions

Virtual Reality Group

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.

Intervention Type: OTHER

Helfer Skin Tap Group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mehmet Akif Ersoy University

OTHER

Sponsor Role: lead

Responsible Party

Hatice ERDEM ÖNDER

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nihal TASKIRAN

Role: STUDY_CHAIR

Aydin Adnan Menderes University

Seyma KISLALI TAS

Role: STUDY_CHAIR

Manisa Soma Family Health Center

Locations

Mehmet Akif Ersoy University

Burdur, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Hatice ERDEM ÖNDER

Role: CONTACT

honder@mehmetakif.edu.tr

+905079741125

Dilek SARI

Role: CONTACT

dilsari@gmail.com

+90 232 311 5569

Other Identifiers

MehmetAkifU-SBF-HEÖ-03

Identifier Type: -

Identifier Source: org_study_id