The Effect of Hologram Application on Pain, Anxiety, and Fear Levels in Children During Burn Dressing

NCT06992895 | Recruiting

• 1 other identifier: AU-HF-MM-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

The process of dressing burn injuries has been shown to cause both physical and psychological difficulties. In children, this process is particularly associated with intense pain and anxiety. Consequently, in addition to pharmacological interventions, non-pharmacological methods such as distraction are employed. In recent years, the utilization of holograms as a method of alleviating pain has emerged as a novel approach. The employment of these visual illusions has been demonstrated to effectively distract children, thereby providing a means of reducing discomfort. The objective of this thesis is to evaluate the effects of hologram application on pain, anxiety, fear, and vital signs during burn dressing in children.

Conditions

Burn Wounds; Burn

Keywords

Holography; Burns; Pain; Anxiety; Fear

Outcome Measures

Primary Outcomes (1)

• The Wong-Baker Faces Pain Rating Scale:

  Measures the pain levels of children by describing their facial expressions. There are six different facial expressions, the lowest score is 0 and the highest score is 5.

  up to 1 hours

Secondary Outcomes (1)

• Children's Fear Scale (CFS):

  up to 1 hours

Other Outcomes (1)

• State-Trait Anxiety Inventory for Children /STAI-CH):

  up to 1 hours

Study Arms (2)

Hologram fan group

EXPERIMENTAL

The technology of hologram fans will be employed in the 3D hologram fan group during the process of burn dressing. This technology utilizes LED lights to create three-dimensional visuals, thereby allowing children to draw their attention to different directions during dressing. Concurrently, scales designed to assess pain, anxiety, and fear will be completed during and immediately following the dressing process. The collection of data will be continued until the calculated number of participants is reached, as determined by the power analysis.

Device: The visual presentation utilizes a three-dimensional holographic fan device.

Control group

NO INTERVENTION

The control group will be subjected to a state of distraction-free environment during the process of burn dressing. The group will undergo standard treatment procedures and will be treated exclusively with conventional methods. Concurrently, scales designed to assess pain, anxiety, and fear will be completed during and immediately following the dressing process. The collection of data will be continued until the calculated number of participants is reached, as determined by the power analysis.

Interventions

The visual presentation utilizes a three-dimensional holographic fan device. DEVICE

This study is among the first to examine the effect of holographic fan technology on pain, anxiety, and fear in children during burn dressing. In comparison with other distraction methods, holographic fans represent a novel technological intervention designed to mitigate pain and anxiety by engaging children's attention through the use of visual illusions. Furthermore, extant studies on the effectiveness of this technology during prolonged and distressing procedures, such as burn dressing, have been found to lack sufficient data.

Hologram fan group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The subject has indicated their willingness to participate in the study. Physical and mental health.
• The age range of the subjects included in this study was from 3 to 12 years of age.
• The subject had never previously engaged in the practice of dressing a burn.
• The presence of only second degree burns
• Burn percentage is under 10%

You may not qualify if:

• The subject is unwilling or unable to provide informed consent or assent (if applicable).
• The subject has a history of significant physical or mental health disorders that may interfere with participation in the study.
• The subject is younger than 3 years old or older than 12 years old.
• The subject has previously engaged in the practice of burn dressing or similar procedures.
• The presence of burns other than second-degree burns (e.g., first-degree or third-degree burns).
• The percentage of burn area is greater than 10%.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (2)

Erzurum Provincial Health Directorate Erzurum City Hospital

Erzurum, Yakutiye, 25040, Turkey (Türkiye)

RECRUITING

Erzurum Provincial Health Directorate Erzurum City Hospital

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Burns; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Zeynep KARAMAN ÖZLÜ, PhD

CONTACT

+905434628682; zynp_krmnzl@hotmail.com

Muhammet MÜEZZİNOĞLU, B.Sc.

CONTACT

+905334396131; muhammetmuezzinoglu6161@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded by not being informed about the groups in the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study was designed as a randomized controlled trial.

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 28, 2025
• Study Start: October 15, 2025
• Primary Completion: May 15, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)