Hologram Burn Dressing on Pain, Anxiety, Fear, Patient Satisfaction, and Physiological Parameters

NCT07244653 | Not Yet Recruiting

• 1 other identifier: TAUNI-BURNHOLO-2025-RCT01
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Burn injuries are a significant global health problem, leading to serious physical, psychological, and social challenges for affected individuals. The literature emphasizes that dressing changes are among the most painful and anxiety-provoking procedures, negatively impacting treatment adherence and patient well-being. Although pharmacological methods are used to alleviate pain and anxiety, they are often insufficient due to potential side effects and addiction risks. In recent years, advancements in digital technologies-particularly virtual reality (VR), augmented reality (AR), and hologram applications-have offered promising distraction-based approaches. Hologram technology, through three-dimensional and interactive visuals, can divert the patient's attention from traumatic stimuli, thereby reducing pain, anxiety, and fear in an innovative way. However, there is limited scientific evidence regarding the use of hologram applications during burn dressing changes. This study aims to examine the effects of hologram applications on pain, anxiety, fear, patient satisfaction, and physiological parameters during burn dressing procedures. The research will be conducted at Erzurum City Hospital Burn Center, with a total of 70 patients assigned to experimental and control groups using simple randomization. Data collection tools will include the Visual Analogue Scale (VAS), the State-Trait Anxiety Inventory (STAI), the Burn Specific Pain Anxiety Scale, satisfaction and fear VAS assessments, and physiological parameter recording forms. The study will be carried out between November 2025 and May 2026. The results are expected to provide evidence-based insights into the feasibility and effectiveness of hologram technology as a non-pharmacological, innovative intervention in burn care.

Conditions

Anxiety; Burn Pain; Burn Patients; Fear

Outcome Measures

Primary Outcomes (7)

• Pain intensity during burn dressing procedure

  Pain intensity will be assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, where \*\*0 indicates "no pain" and 10 indicates "the worst possible pain." Higher scores indicate greater pain intensity.

  Immediately after the first and second dressing procedures (approximately 15-30 minutes each).

• State-Trait anxiety level

  State anxiety will be assessed using the State subscale of the State-Trait Anxiety Inventory (STAI-S). The scale ranges from 20 to 80 points, where higher scores indicate greater anxiety levels, and lower scores indicate reduced anxiety.

  Immediately after the first and second dressing changes.

• Burn-specific pain-related anxiety

  Burn-specific pain-related anxiety will be assessed using the Burn Specific Pain Anxiety Scale (BSPAS). The scale ranges from 0 to 4 for each item, with a total score range of 0-64. Higher scores indicate greater levels of pain-related anxiety associated with burn procedures, while lower scores indicate reduced anxiety.

  Immediately after the first and second dressing procedures.

• Fear level

  Fear will be assessed using the Visual Analogue Scale (VAS) for Fear, ranging from 0 to 10, where \*\*0 indicates "no fear" and 10 indicates "the highest possible fear." Higher scores indicate greater fear intensity.

  Immediately after the first and second dressing procedures.

• Patient satisfaction

  Patient satisfaction will be evaluated using the Visual Analogue Scale (VAS) for Satisfaction, ranging from 0 to 10, where \*\*0 indicates "no satisfaction" and 10 indicates "maximum satisfaction." Higher scores indicate greater satisfaction with the dressing procedure.

  Immediately after the first and second dressing procedures.

• Physiological parameter: Heart rate

  Heart rate will be measured using a standard patient monitor and recorded before, during, and immediately after each dressing procedure. Heart rate will be reported in beats per minute (bpm), where higher values indicate increased physiological stress, and lower values indicate reduced stress response.

  Within each of the first and second dressing sessions (approximately 15-30 minutes).

• Physiological parameter: Oxygen saturation

  Oxygen saturation will be measured using a standard patient monitor and reported as percentage (%) of oxygenated hemoglobin (SpO₂). Lower values may indicate higher physiological stress or discomfort, whereas higher values indicate better physiological stability.

  Within each of the first and second dressing sessions (approximately 15-30 minutes).

Study Arms (2)

Control: Standard nursing care

NO INTERVENTION

Refers to routine, evidence-based, and protocol-driven nursing procedures performed during burn dressing without any additional non-pharmacological interventions. This includes wound cleaning, dressing application, patient monitoring, pharmacological pain management as prescribed, and therapeutic communication supported by institutional burn care guidelines.

Intervention

EXPERIMENTAL

Hologram Application During Burn Dressing

Other: Showing videos with holograms

Interventions

Showing videos with holograms OTHER

The intervention in this study is the use of a three-dimensional hologram video as a distraction method during burn dressing procedures. Unlike conventional video or virtual reality (VR) applications, the hologram projects interactive 3D images into real space without requiring headsets or wearable devices. Patients can visually perceive the holographic content directly in front of them, allowing natural interaction and immersion. This feature provides a stronger distraction effect by engaging the patient's attention with vivid and dynamic images during the painful procedure. Thus, the hologram differs from standard video watching by offering an immersive, spatial, and realistic experience that does not restrict movement or require equipment contact with the burned area.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18 and 65,
• Able to read, write, and speak Turkish,
• Not participating in any other clinical trials at the same time,
• Patients who were decided to be admitted to a burn unit,
• No infected cases,
• Patients who did not undergo minor and/or major surgical procedures that could affect the wound healing process,
• No chronic illness other than burns,
• No cognitive, sensory, or other problems that would prevent verbal communication and understanding the information given,
• Second-degree burn with a total body surface area (TBSA) of less than 20%; Patients were included in the study if their burn rate was below 15% (20% in Grade 2 patients; sedation was required in Grade 3 patients with burn rates above 15%),
• nd and 3rd degree burns in the granulation stage (2nd and 3rd degree burns requiring granulation treatment and experiencing high pain),
• No burns on the head, ears, or face,
• Daily dressing changes with a frequency of 1-15 dressing changes,
• No complaints that would prevent participation in the study, such as respiratory problems,
• No vision or hearing problems.

You may not qualify if:

• Those with a pain intensity between 8 and 10 points (sedation is required when the pain intensity is 8 or higher),
• Those under the influence of various non-pharmacological treatment methods that may affect pain,
• Patients requiring advanced surgical procedures such as fasciotomy, escharotomy, or amputation,
• Patients receiving sedation during the dressing,
• Patients interrupting the hologram video during the dressing,
• First-degree burns,
• Those with neurological, psychological, or psychiatric illnesses,
• Patients receiving sedation during the dressing,
• Patients interrupting the hologram video during the dressing

Sponsors & Collaborators

• Gamze BULUT: lead
• Ataturk University: collaborator

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Gamze BULUT ÖZLÜ

CONTACT

+905533826019; gamze.bulut@atauni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant, Department of Surgical Nursing

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 24, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share