Effect of Virtual Reality Headsets on Fear Anxiety and Physiological Parameter in Skin Prick Test

TC Erciyes University

Status: Not yet enrolling

Conditions: Allergy

Study type: Observational

Funder types: Other

Identifiers

NCT06401408

ERU-NF-KB-01

Details and patient eligibility

About

The goal of this clinical trial is determine the effect of virtual reality headsets on pain, anxiety, fear and physiological parameters in children aged 4-7 years who undergoing skin prick test. The main questions it amis to answer are:

Virtual reality headsets effect on the pain that during the procedure

Virtual reality headsets effect on the anxiety that occurs during the procedure

Virtual reality headsets effect on the fear that occurs during the procedure

Virtual reality headsets effect on physiological parameters (heart rate, blood pressure, respiratory rate) during the procedure

Full description

Before starting the skin prick test, the child and his/her family who meet the inclusion criteria of the study will be informed about the use of virtual reality headsets(VRH) and volunteer consent forms will be obtained. Before starting the test (5 minutes before), the Introductory Characteristics Form for Children and Their Families and scales (so that the pain, fear and anxiety scores predicted by the children before the procedure will be measured) will be applied to the children and the child's physiological parameters (heart rate, blood pressure, respiratory rate, oxygen saturation value) will be taken. Then, the children will be fitted with an VRH and watched an animated film (approximately 15 minutes long) determined in line with the child's age group, developmental characteristics and expert opinions.After the child starts watching the video, skin prick test procedures will be initiated and the child will be allowed to watch the video until the test ends. After the test is completed (5 minutes later), physiological parameters will be taken again and scales (thus measuring the pain, fear and anxiety scores felt by the children during the procedure) will be applied.

Control group application phase:

No intervention/application will be performed on the children who will be included in the control group. The Introductory Characteristics of Children and Their Families Form and scales will be administered to the children in the control group simultaneously with the experimental group (in the form of pretest-posttest). Additionally, physiological parameters will be taken simultaneously with the experimental group.

Enrollment: 32 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Between the ages of 4-7,
2. Does not have a chronic or genetic disease,
3. No mental, visual or hearing impairment,
4. No analgesics or sedatives were administered at least one hour before the test procedure,
5. Both he and his parents are open to communication and cooperation,
6. Children who both themselves and their parents volunteer to participate in the research and give verbal and written consent will be included.

Exclusion criteria

1. Those who are outside the 4-7 age range,
2. Having a chronic or genetic disease,
3. Mentally, visually or hearing impaired,
4. Applying analgesics and sedatives at least one hour before the test procedure,
5. The child who cannot adapt to virtual reality glasses,
6. Both he and his parents do not cooperate,
7. Children who neither they nor their parents volunteer to participate in the research and who do not give verbal or written consent will not be included in the research.

Trial design

32 participants in 2 patient groups

case group

Description:

Before starting the skin prick test, the child and his/her family who meet the inclusion criteria of the study will be informed about the use of virtual reality headsets(VRH) and volunteer consent forms will be obtained. Before starting the test, the Introductory Characteristics Form for Children and Their Families and scales will be applied to the children and the child's physiological parameters will be taken. Then, the children will be fitted with an VRH and watched an animated film determined in line with the child's age group, developmental characteristics and expert opinions.After the child starts watching the video, skin prick test procedures will be initiated and the child will be allowed to watch the video until the test ends. After the test is completed, physiological parameters will be taken again and scales will be applied.

control group

Description:

No intervention/application will be performed on the children who will be included in the control group. The Introductory Characteristics of Children and Their Families Form and scales will be administered to the children in the control group simultaneously with the experimental group (in the form of pretest-posttest). Additionally, physiological parameters will be taken simultaneously with the experimental group.