Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency

NCT ID: NCT07004803

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-15

Study Completion Date

2025-10-15

Brief Summary

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In this study, it is aimed to investigate the effect of virtual reality and tablet video viewing intervention on pain and fear levels and vital signs of children during peripheral venous catheter placement for intravenous immunoglobulin (IVIG) administration.

Detailed Description

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Conditions

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Primary Immunodeficiency Diseases (PID)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Virtual reality group

Group Type EXPERIMENTAL

Virtual reality video watching

Intervention Type OTHER

The children in the VR experimental group of the study will be subjected to the clinic's routine venipuncture procedure and the video-watching intervention with virtual reality headset. Routine care includes informing the child and parents about the procedure and questions that strengthen communication and distract attention. For example, it consists of questions such as 'How old are you?', 'Do you go to school?', 'Can you tell me the name of your favorite friend?'. Virtual reality headset will be introduced to the child before the procedure and information about how to use them will be given. After the measurements, intravenous access will be started. During the procedure, children will be shown a roller coaster video on virtual reality headset. The video-viewing process will be started 2 minutes before the venipuncture procedure. The video viewing time is planned to last an average of 4 minutes. Measurements were made during and after the procedure

Tablet group

Group Type ACTIVE_COMPARATOR

Tablet video watching

Intervention Type OTHER

The children in the experimental group of the study will be subjected to the clinic's routine venipuncture procedure and the video-watching intervention with Tablet. Routine care includes informing the child and parents about the procedure and questions that strengthen communication and distract attention. For example, it consists of questions such as 'How old are you?', 'Do you go to school?', 'Can you tell me the name of your favorite friend?'. Tablet will be introduced to the child before the procedure and information about how to use them will be given. After the measurements, intravenous access will be started. During the procedure, children will be shown a roller coaster video on tablet. The video-viewing process will be started 2 minutes before the venipuncture procedure. The video viewing time is planned to last an average of 4 minutes. Measurements were made during and after the procedure.

Interventions

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Virtual reality video watching

The children in the VR experimental group of the study will be subjected to the clinic's routine venipuncture procedure and the video-watching intervention with virtual reality headset. Routine care includes informing the child and parents about the procedure and questions that strengthen communication and distract attention. For example, it consists of questions such as 'How old are you?', 'Do you go to school?', 'Can you tell me the name of your favorite friend?'. Virtual reality headset will be introduced to the child before the procedure and information about how to use them will be given. After the measurements, intravenous access will be started. During the procedure, children will be shown a roller coaster video on virtual reality headset. The video-viewing process will be started 2 minutes before the venipuncture procedure. The video viewing time is planned to last an average of 4 minutes. Measurements were made during and after the procedure

Intervention Type OTHER

Tablet video watching

The children in the experimental group of the study will be subjected to the clinic's routine venipuncture procedure and the video-watching intervention with Tablet. Routine care includes informing the child and parents about the procedure and questions that strengthen communication and distract attention. For example, it consists of questions such as 'How old are you?', 'Do you go to school?', 'Can you tell me the name of your favorite friend?'. Tablet will be introduced to the child before the procedure and information about how to use them will be given. After the measurements, intravenous access will be started. During the procedure, children will be shown a roller coaster video on tablet. The video-viewing process will be started 2 minutes before the venipuncture procedure. The video viewing time is planned to last an average of 4 minutes. Measurements were made during and after the procedure.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being between the ages of 4-11
* Being followed up with the diagnosis of Primary Immunodeficiency for at least 6 months
* To accept participation in the study voluntarily
* No additional chronic disease other than primary immunodeficiency

Exclusion Criteria

* Organ failure is present
* Having a mental deficiency
* Having a disability to use VR Glasses
* Children with fever (\|\>37.5 C0)
* Children with severe dehydration
Minimum Eligible Age

4 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karamanoğlu Mehmetbey University

OTHER

Sponsor Role collaborator

Dr. Hatice Dönmez

OTHER

Sponsor Role lead

Responsible Party

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Dr. Hatice Dönmez

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Karamanoglu Mehmetbey University

Karaman, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hatice Dönmez, PhD

Role: CONTACT

+905067715841

Facility Contacts

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Hatice Dönmez, PhD

Role: primary

Other Identifiers

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16-M-24

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KMU-SBF-HD-01

Identifier Type: -

Identifier Source: org_study_id

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