The Effect of Virtual Reality and Buzzy Application on Pain, Fear and Anxiety During Prick Test in Children

NCT ID: NCT06443060

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2025-12-15

Brief Summary

Allergy is a hypersensitivity reaction to a triggering agent. Tests used in allergy are divided into two: in vivo and in vitro. Among the in vivo tests routinely used, epidermal, intradermal and patch tests are used, and the most commonly used is the skin prick test. In order to prevent the negative effects of pain, it is important to be informed about the appropriate approach to children, newborns and babies, and effective pain management, according to their cognitive development levels. Pain management in children should be done appropriately with accurate assessment tools. This will increase the quality of life, reduce hospitalizations, shorten the length of hospital stay and reduce costs. Pain experiences experienced during childhood will cause later pain experiences to be perceived as more severe and cause anxiety and fear. Anxiety is a psychological, physiological and behavioral state that develops in response to a perceived or existing threat. Anxiety, which can also be expressed as worry or anxiety, is a emotional state that can occur in various ways, such as restlessness, tension, easy fatigue, lack of concentration, muscle tension, and sleep disturbance, in which autonomic and somatic symptoms occur in the body, without any reason.

Virtual reality provides multi-sensory information as children focus on the simulated world. Virtual reality, one of the cognitive methods; It can create an environment where three-dimensional pictures or animations created on the computer can interact in people's minds. It is also defined as a distraction method created by software, which creates the feeling that users are in the environment even though they are not in the real environment, and can interact with people in the environment. When all these studies were examined, no three-group study was found comparing a distracting method with a physical method for the 7-10 age group. Additionally, there is a study that used virtual reality in the prick test, but there is no method that has been proven to be superior to virtual reality. In this study, it will be investigated whether virtual reality and buzzy applications have a reducing effect on pain, fear and anxiety compared to the control group. Virtual reality and buzzy techniques will also be compared with each other. Since no such study has been found in the literature, it is thought to contribute to the field.

Detailed Description

Allergy is a hypersensitivity reaction to a triggering agent. Tests used in allergy are divided into two: in vivo and in vitro. Among the in vivo tests routinely used, epidermal, intradermal and patch tests are used, and the most commonly used is the skin prick test. In order to prevent the negative effects of pain, it is important to be informed about the appropriate approach to children, newborns and babies, and effective pain management, according to their cognitive development levels. Pain management in children should be done appropriately with accurate assessment tools. This will increase the quality of life, reduce hospitalizations, shorten the length of hospital stay and reduce costs. Pain experiences experienced during childhood will cause later pain experiences to be perceived as more severe and cause anxiety and fear. Anxiety is a psychological, physiological and behavioral state that develops in response to a perceived or existing threat. Anxiety, which can also be expressed as worry or anxiety, is a emotional state that can occur in various ways, such as restlessness, tension, easy fatigue, lack of concentration, muscle tension, and sleep disturbance, in which autonomic and somatic symptoms occur in the body, without any reason.

Virtual reality provides multi-sensory information as children focus on the simulated world. Virtual reality, one of the cognitive methods; It can create an environment where three-dimensional pictures or animations created on the computer can interact in people's minds. It is also defined as a distraction method created by software, which creates the feeling that users are in the environment even though they are not in the real environment, and can interact with people in the environment.

When all these studies were examined, no three-group study was found comparing a distracting method with a physical method for the 7-10 age group. Additionally, there is a study that used virtual reality in the prick test, but there is no method that has been proven to be superior to virtual reality. In this study, it will be investigated whether virtual reality and buzzy applications have a reducing effect on pain, fear and anxiety compared to the control group. Virtual reality and buzzy techniques will also be compared with each other. Since no such study has been found in the literature, it is thought to contribute to the field.

Conditions

Pain; Fear; Anxiety; Children, Only; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Group

After the scales are filled in, the child will be shown a cartoon film deemed appropriate by the experts by wearing VR glasses and headphones before the Prick test (average 2 minutes). The appropriate cartoon will be shown to the VR glasses group for an average of 15 minutes. After the child starts watching the cartoon, the child will be asked to extend his/her left arm and the prick test process will begin.

Group Type: EXPERIMENTAL

Virtual Reality Group

Intervention Type: BEHAVIORAL

Before starting the Prick procedure, the child in the virtual reality group, which is determined by randomisation, will be given a brief information about how the allergy test will be performed and about virtual reality. Before the Prick test (approximately 2 minutes before the Prick test), the child will start to watch a film deemed appropriate by the experts by wearing virtual reality and headphones. After the child starts watching the film, the child will be asked to extend his/her left arm and solutions will be dripped on the forearm and the puncture will be performed with a lancet. The child will continue to watch the film during the whole procedure.

Buzzy Application Group

The CFS-D scale will be completed only by the child to measure the anxiety level before the procedure. To assess pain and fear, the WB-FACES pain scale and the CFS fear scale will be completed by the child, parent and researcher before the procedure. The buzzy cold and vibration device will be connected to the children in the buzzy experimental group 5-10 seconds before the procedure, at least 8-10 cm above the area to be treated (upper part of the left arm antecubital fossa) and the prick test application will be started.

Group Type: EXPERIMENTAL

Buzzy Application Group

Intervention Type: BEHAVIORAL

Before starting the prick procedure, the child in the buzzy group, which was determined by randomisation, will be given a brief information about how the allergy test will be performed and the buzzy device. The children in the buzzy experimental group will be connected to the buzzy cold and vibration device at least 8-10 cm above the area to be treated (upper part of the left arm antecubital fossa) 5-10 seconds before starting the procedure and the prick test application will be started.

Control Group

Children in this group will be given routine explanations according to the outpatient clinic procedure and prick test will be applied before the procedure.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

Before starting the prick procedure, the children in the control group determined by randomisation will be given routine explanations according to the outpatient clinic procedure before starting the procedure and the prick test will be applied.

Interventions

Virtual Reality Group

Before starting the Prick procedure, the child in the virtual reality group, which is determined by randomisation, will be given a brief information about how the allergy test will be performed and about virtual reality. Before the Prick test (approximately 2 minutes before the Prick test), the child will start to watch a film deemed appropriate by the experts by wearing virtual reality and headphones. After the child starts watching the film, the child will be asked to extend his/her left arm and solutions will be dripped on the forearm and the puncture will be performed with a lancet. The child will continue to watch the film during the whole procedure.

Intervention Type: BEHAVIORAL

Buzzy Application Group

Before starting the prick procedure, the child in the buzzy group, which was determined by randomisation, will be given a brief information about how the allergy test will be performed and the buzzy device. The children in the buzzy experimental group will be connected to the buzzy cold and vibration device at least 8-10 cm above the area to be treated (upper part of the left arm antecubital fossa) 5-10 seconds before starting the procedure and the prick test application will be started.

Intervention Type: BEHAVIORAL

Control Group

Before starting the prick procedure, the children in the control group determined by randomisation will be given routine explanations according to the outpatient clinic procedure before starting the procedure and the prick test will be applied.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The child must be between the ages of 7-10
• It will be the first time that a prick test will be applied.
• The child can speak and understand Turkish comfortably
• He and his family agree to participate in the study.
• Not having used analgesic medication at least six hours ago

Exclusion Criteria

• The child has any diagnosed psychiatric disorder
• Having visual, auditory or speech disorders
• Having a chronic disease other than allergy

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KTO Karatay University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emine Geçkil

Role: PRINCIPAL_INVESTIGATOR

Necmettin Erbakan Üniversitesi Hemşirelik Fakültesi

Central Contacts

Funda Gürbüz

Role: CONTACT

fundakaya033@gmail.com

05065005321 ext. 7522

Emine Geçkil

Role: CONTACT

eminegeckil@gmail.com

0506 628 54 60

Other Identifiers

FundaTEZ

Identifier Type: -

Identifier Source: org_study_id