Clinical trial NCT06895330: Effects of Virtual Reality and Helfer Skin Tap During Vaccination
Official title: Virtual Reality Vs. Helfer Skin Tap: Which One is Helping Children Cope with Fear, Anxiety, and Pain During Vaccination?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain Management
Fear
Anxiety
Satisfaction
Keywords: pain
fear
anxiety
satistaction
virtual reality
helfer skin tap
vaccine
Lead sponsor: Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 138
Sex: ALL
Minimum age (years): 13
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were randomly assigned to Virtual reality, Helfer skin tap, and control groups.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: The Visual Analog Scale (VAS) will be administered immediately prior to and immediately following the vaccination procedure.
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: State-Trait Anxiety Inventory (STAI) will be administered immediately prior to and immediately following the vaccination procedure.
measure: Children Fear Scale
timeFrame: Children Fear Scale will be administered immediately prior to and immediately following the vaccination procedure.
measure: Satisfaction level
timeFrame: Satisfaction will be assessed immediately after the vaccination procedure.
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Mehmet Akif Ersoy University
Study officials:
affiliation: Aydin Adnan Menderes University
name: Nihal TASKIRAN
role: STUDY_CHAIR
affiliation: Manisa Soma Family Health Center
name: Seyma KISLALI TAS
role: STUDY_CHAIR
References: