AnxietyNCT07244653
Hologram Burn Dressing on Pain, Anxiety, Fear, Patient Satisfaction, and Physiological Parameters
A study testing Showing videos with holograms in people with Anxiety and Burn Pain, run by Gamze BULUT at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Burn Pain, Burn Patients
- What is being tested?
- Showing videos with holograms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2025to 20 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk Universty, Nursing faculty
Erzurum, Erzurum, 25000
About this study
Official title: Effect of Hologram Application During Burn Dressing on Pain, Anxiety, Fear, Patient Satisfaction, and Physiological Parameters: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Anxiety, Burn Pain, Burn Patients, Fear
- Being tested
- Showing videos with holograms
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Showing videos with hologramsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Showing videos with holograms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within each of the first and second dressing sessions (approximately 15-30 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start31 Dec 2025
- Primary completion20 Jul 2026
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamze BULUT
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor-investigator, Gamze BULUT, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244653
- Sponsor's protocol ID
- TAUNI-BURNHOLO-2025-RCT01
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) will not be shared due to patient privacy protection, ethical considerations, and institutional restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hologram Application During Burn Dressing on Pain, Anxiety, Fear, Patient Satisfaction, and Physiological Parameters: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07244653
- Acronym / sponsor ID
- TAUNI-BURNHOLO-2025-RCT01
- Conditions
- Anxiety, Burn Pain, Burn Patients, Fear
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Gamze BULUTUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Showing videos with hologramsHologram Application During Burn Dressing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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,
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Showing videos with hologramsThe 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. | Other | Intervention |
Primary outcome
Pain intensity during burn dressing procedure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) will not be shared due to patient privacy protection, ethical considerations, and institutional restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Showing videos with holograms in people with Anxiety and Burn Pain, run by Gamze BULUT at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity during burn dressing procedure (time frame: Immediately after the first and second dressing procedures (approximately 15-30 minutes each).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.