Effects of Virtual Reality and Helfer Skin Tap During Vaccination

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.

• State-Trait Anxiety Inventory (STAI) [Срок оценки: State-Trait Anxiety Inventory (STAI) will be administered immediately prior to and immediately following the vaccination procedure.]
• Children Fear Scale [Срок оценки: Children Fear Scale will be administered immediately prior to and immediately following the vaccination procedure.]
• Satisfaction level [Срок оценки: Satisfaction will be assessed immediately after the vaccination procedure.]