Effects of Virtual Reality and Helfer Skin Tap During Vaccination
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-13
SponsorMehmet Akif Ersoy University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
13 years
being conscious (with the ability to communicate)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality Group
Other interventionA 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
Other interventionThe 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.
Treatment groups
138 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality GroupExperimental treatment 1 intervention
Group B: Helfer Skin Tap GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
The Visual Analog Scale (VAS) will be administered immediately prior to and immediately following the vaccination procedure.Secondary outcomes
1
State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) has been employed in clinical settings to assess levels of both state (STAI-S; i.e., current) and trait (STAI-T; i.e., long-term, general) anxiety. This formwas developed by Spielberger et al. (1971) to measure the anxiety levels of children. The STAI-S was adapted into Turkish by Özusta in 1995, and its validity and reliability study was conducted. The inventory is a 3-point Likert-type scale consisting of 20 items that aim to evaluate feelings associated with state anxiety. The children evaluated how they felt 'at that moment' as "almost never" (1 point), "sometimes" (2 points), and "often" (3 points). The scale ranges from 20 to 60 points, with a high score indicating a high level of anxiety.
Time frame
State-Trait Anxiety Inventory (STAI) will be administered immediately prior to and immediately following the vaccination procedure.2
Children Fear Scale
The scale consists of five face shapes scored from 0 to 4. A score of 0 indicates no fear, while a score of 4 indicates serious fear.
Time frame
Children Fear Scale will be administered immediately prior to and immediately following the vaccination procedure.3
Satisfaction level
Children will asked to rate their satisfaction level with the vaccination on a scale of 0 points "not satisfied" to 10 points "very satisfied".
Time frame
Satisfaction will be assessed immediately after the vaccination procedure.Sponsors and contacts
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Source ClinicalTrials.gov
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