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临床试验/NCT07244653
NCT07244653进行中(未招募)不适用

Effect of Hologram Application During Burn Dressing on Pain, Anxiety, Fear, Patient Satisfaction, and Physiological Parameters: A Randomized Controlled Trial

Gamze BULUT1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年12月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
72
试验地点
1
主要终点
Pain intensity during burn dressing procedure

研究概览

简要总结

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.

详细描述

Burn injuries represent a major global health concern, resulting in substantial physical, psychological, and social burden for individuals. Among the therapeutic procedures applied in burn care, dressing changes are consistently reported as one of the most painful and anxiety-inducing interventions. These procedures may negatively influence treatment adherence, prolong recovery, and reduce the overall quality of life for patients. While pharmacological agents are commonly administered to reduce pain and anxiety during burn dressing, they may fail to provide adequate relief and can be associated with undesirable side effects and drug dependency risks. Therefore, there is a growing emphasis on complementary, non-pharmacological strategies that can enhance patient comfort and procedural tolerance.

With rapid advances in digital health technologies, immersive visual distraction methods such as virtual reality (VR), augmented reality (AR), and hologram-based systems have emerged as novel interventions in clinical settings. Hologram technology, which presents interactive three-dimensional images, may effectively shift the patient's focus away from traumatic procedures and reduce negative emotional responses. This innovative technique has the potential to minimize pain, anxiety, and fear by engaging cognitive and sensory pathways associated with distraction. Despite its promising nature, current scientific evidence regarding hologram applications during burn dressing changes remains limited, and there is a lack of controlled clinical trials evaluating its efficacy.

This randomized controlled study aims to investigate the effects of hologram application during burn dressing procedures on pain, anxiety, fear, patient satisfaction, and physiological responses. The study will be conducted with 70 patients receiving treatment at the Burn Center of Erzurum City Hospital. Participants will be randomly assigned to the experimental group, in which hologram technology will be applied during dressing changes, or to the control group receiving standard care. Data will be collected using validated tools including the Visual Analogue Scale (VAS) for pain and satisfaction, the Burn Specific Pain Anxiety Scale, the State-Trait Anxiety Inventory (STAI), fear assessment through VAS, and physiological monitoring forms for parameters such as heart rate, respiratory rate, and blood pressure. The research will be carried out between November 2025 and May 2026.

The findings of this study are expected to contribute high-quality evidence on the impact of hologram-based distraction as a non-pharmacological intervention in burn care. Results may support the integration of hologram technology into clinical practice to promote patient comfort, reduce emotional distress, and enhance overall treatment experience during burn dressing procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Between the ages of 18-65,
  • •Able to read, write, and speak Turkish,
  • •Not participating in any other clinical research at the same time,
  • •Patients without epilepsy who have been admitted to the burn unit for treatment,
  • •Non-infected cases,
  • •Patients who have not undergone minor and/or major surgical procedures (fasciotomy, escharotomy, amputation, etc.) that may affect the wound healing process,
  • •Without any cognitive, affective, or other problems that may prevent them from communicating verbally and understanding information,
  • •Total body surface area (TBSA) of burns is less than 20% of the second degree; Patients with a 3rd degree burn below 15% (20% in 2nd degree patients; sedation required in 3rd degree patients above 15%),
  • •2nd and 3rd degree burns in the granulation stage (2nd and 3rd degree burns requiring treatment and high pain levels),
  • •Not affected by different non-drug treatment methods that would affect pain,
  • •Undergoing standard analgesia protocol,
  • •No burns on the head, ears, or face,
  • •Burns of hot liquid contact (scald),
  • •Patients whose initial burn dressing was performed at the burn center where the study was conducted, with dressing changes every two days and at least two consecutive dressing changes were included in the study.

排除标准

  • •Patients who developed any complications during two consecutive dressing changes (sepsis, fever, hemodynamic instability, wound infection, new trauma to the burn area, or conditions requiring additional surgical intervention, etc.),
  • •Patients diagnosed with epilepsy were excluded from the study due to the risk of seizure triggering by photosensitive stimuli.

研究组 & 干预措施

Intervention

Experimental

Hologram Application During Burn Dressing

干预措施: Showing videos with holograms (Other)

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.

结局指标

主要结局

Pain intensity during burn dressing procedure

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

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.

State-Trait anxiety level

时间窗: Immediately after the first and second dressing changes.

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.

Burn-specific pain-related anxiety

时间窗: Immediately after the first and second dressing procedures.

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.

Fear level

时间窗: Immediately after the first and second dressing procedures.

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.

Patient satisfaction

时间窗: Immediately after the first and second dressing procedures.

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.

Physiological parameter: Heart rate

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

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.

Physiological parameter: Oxygen saturation

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

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.

次要结局

未报告次要终点

研究者

发起方
Gamze BULUT
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gamze BULUT

Research Assistant, Department of Surgical Nursing

Ataturk University

研究点 (1)

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