Respiratory Infections, AcuteNCT06893237
The Effect of Virtual Reality Goggles and Distraction Cards Applied to Children Aged 6-12 Years During Inhaler Therapy on Physiological Parameters and Anxiety
A study testing virtual reality goggles and inhalation treatment, distraction cards and inhalation therapy and inhalation therapy in people with Respiratory Infections, Acute and Respiratory Tract Diseases, run by Uskudar University.
Trial summary
In the literature, studies examining the effect of virtual reality application on physiological parameters and anxiety during inhalation therapy, which is frequently used in children, are quite limited. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Respiratory Infections, Acute, Respiratory Tract Diseases
- What is being tested?
- virtual reality goggles and inhalation treatment, distraction cards and inhalation therapy and inhalation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Apr 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child is receiving inhalation (salbutamol) treatment in the pediatric intensive care unit.
- The child must be between 6-12 years old
- The child must not have any vision or hearing problems.
- Being conscious and being able to communicate verbally
- After being informed, the child and parent agree to participate in the study in writing and verbally
- No genetic, congenital, chronic or metabolic disease
- The child has no signs of respiratory failure
Who cannot join
- The child's clinical treatment is due to a history of surgery,
- The child is taking a sedative medication,
- The child has a fever over 37°C,
- The child has applied with a severe asthma attack,
- The child's saturation value is below 92% at the time of application.
About this study
Official title: The Effect of Virtual Reality Goggles and Distraction Cards Applied to Children Aged 6-12 Years During Inhaler Therapy on Physiological Parameters and Anxiety: a Randomised Controlled Study
In the literature, studies examining the effect of virtual reality application on physiological parameters and anxiety during inhalation therapy, which is frequently used in children, are quite limited. Therefore, this study will be conducted to determine the effect of virtual reality goggles and distraction cards on physiological parameters and anxiety in patients receiving inhalation therapy.
Read the detailed description
According to the Global Sustainable Development Report, virtual reality (VR) is one of the issues that are expected to bring about major innovations in applications, and this concept was first used by Jaron Lanier towards the end of the 1980s. VR enables computer-generated three-dimensional images and animations to interact with these objects in the environment while giving the feeling of being in a real environment in people's minds with technological tools. The purpose of VR is to make the user believe that they are in the computer-generated environment as much as possible. According to the Turkish Language Association, it is defined as 'a three-dimensional environment created by giving imitations of real environments in a virtual sphere that provides 360-degree vision using artificial intelligence, where unreal environments can be experienced as real, solving complex problems, information transfer, entertainment, etc. It is used for purposes'. Virtual reality technology is used in the field of health as a method of distraction that provides various visual, auditory, tactile and olfactory stimuli and real perceptual stimuli and is applied in many processes related to care and treatment in the health sector, especially in children. Technologies used in health care services accelerate the recovery of patients and provide ease of operation to health professionals. Children encounter many acute or chronic diseases during their developmental period. Hospitalisation as a result of these diseases is complicated and stressful for children and their families and can cause fear, anxiety and anxiety in children. Medical procedures encountered during hospitalisation are the main source of fear for children. They may experience anger, helplessness and anxiety due to reasons such as unfamiliar environment, change in the routine of the child, different sound, light, tools and equipment, unfamiliar people, painful painful procedures, being away from family and friends, loss of control, activity limitation, communication difficulties, presence of other children crying. The use of technology in preparation for or during medical procedures is an effective method in providing anxiety and comfort. Virtual reality is used in injection applications, intravenous interventions, burn dressings and postoperative pain experiences and physiological parameters in children and adolescents. Kurban and Şener investigated the effect of virtual reality goggles applied during vaccination on pain and anxiety in children aged 6-12 years and reported that the VR group had significantly lower pain and anxiety scores. In a systematic review conducted by Nacaroğlu et al. to examine the effect of virtual reality applications on pain and anxiety perception during invasive and painful procedures in school-age children in Turkey, it was reported that VR application positively affected pain and anxiety. In the study conducted by Okay and Okay in 2024 to examine the effect of virtual reality goggles on physiological parameters during inhalation therapy in children aged 2-5 years, it was observed that children watching videos with virtual reality goggles decreased the number of respirations and heart rate per minute, increased oxygen saturation values, decreased crying time and increased treatment efficacy. At the same time, although each child has different interests, it was observed that children experienced less fear and anxiety in studies where calming ocean videos were watched. Respiratory system diseases are frequently seen in childhood and constitute a significant portion of hospital admissions. Respiratory system diseases are an important cause of mortality and morbidity all over the world, a serious public health problem in developed and developing countries, and constitute 8.2% of all disabilities. According to WHO, respiratory tract infections are the most common cause of mortality in children under five years of age and are responsible for 19% of child deaths. According to the data of Turkish Statistical Institute (TurkStat), upper respiratory tract infections (URTI) are the most common disease in the 0-14 age range in our country. Inhalation therapy, which is one of the important methods in the management of respiratory system diseases, is frequently used in paediatric patients to relieve bronchospasm and to relieve the airway by delivering drug particles to the extreme lobes of the lungs. Inhalation therapy is frequently preferred because of its rapid effect, the absence of the need for an intravenous catheter and thus the absence of injection-related pain, the direct effect of the drug on the desired area (lungs), the low side effects on other systems, and the fact that it can be used at any age. Although inhalation treatment with mask is an easy intervention, it is an application that causes fear and anxiety in children. Success in treatment is ensured by the compliance of the child and the family. Children generally do not accept mask treatment and show crying and refusal behaviour. Since the crying of the child during the treatment will reduce intrapulmonary storage, the amount of drug reaching the lungs will decrease and may adversely affect the treatment. At the same time, respiratory distress experienced by children causes anxiety, dyspnoea and increase in respiratory rate. For these reasons, children receiving inhalation therapy should be calm. In order to provide effective inhalation therapy, it is recommended to use evidence-based distraction methods. There are many methods used to divert attention. Some of these are; watching cartoons, hypnotherapy, playing with toys, using virtual reality goggles, music therapy, play therapy, using kaleidoscope and using distraction cards. The method used to divert the attention of paediatric patients should affect both visual and auditory senses and at the same time be appropriate for the development of the child. The aim of the paediatric nurse is to protect and improve the mental, physical, social and spiritual health of the child and to provide holistic care for treatment in the presence of disease. In the literature, studies examining the effect of virtual reality application on physiological parameters and anxiety during inhalation therapy, which is frequently used in children, are quite limited. Therefore, this study will be conducted to determine the effect of virtual reality goggles and distraction cards on physiological parameters and anxiety in patients receiving inhalation therapy.
- Being tested
- virtual reality goggles and inhalation treatment, distraction cards and inhalation therapy, inhalation therapy
- Keywords
- inhalation therapy, child, virtual reality glasses, anxiety, distraction of attention
- Medical subject headings
- Respiratory Tract Infections, Respiratory Tract Diseases, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality goggles and inhalation treatmentOther
Video recording will be started after the consent is obtained. One minute before the procedure, the child's physical parameters (peak heart rate, respiratory rate, oxygen saturation) and anxiety will be measured and recorded. Then, the child will be fitted with virtual reality goggles and inhalation treatment will be started by watching the aquarium and sea creatures video. Inhalation treatment will last for 10 minutes with the most appropriate air flow rate of 6-8 L/min. Then, the virtual reality goggles will be removed and the child's physiological parameters and anxiety will be measured and recorded again after 1 minute. For participants who want to participate in the study but do not approve the video recording, the evaluations will be made by a nurse independent of the study.
distraction cards and inhalation therapyOther
After the consent is obtained, the video recording will be started. 1 minute before the procedure, the child's physical parameters (heart rate, respiratory rate, oxygen saturation) and anxiety will be measured and recorded. Then, the child will be shown distraction cards and inhalation therapy will be started simultaneously. Playing with the distraction cards will continue for 10 minutes until the end of the inhalation therapy. Then, the use of the toys will be stopped and the child's physiological parameters and anxiety will be recorded after 1 minute. The video recording will be ended. For participants who want to participate in the study but do not consent to being video recorded, the evaluations will be made by a nurse independent of the study.
inhalation therapyOther
After the consent is received, the video recording will be started. 1 minute before the procedure, the child's physical parameters (heart rate, respiratory rate, oxygen saturation) and anxiety will be measured and recorded. Then, inhalation therapy will be started with routine service application. The child will receive inhalation therapy for 10 minutes. 1 minute after the procedure, physiological parameters and anxiety will be measured and recorded again. The video recording will be ended. For participants who want to participate in the study but do not approve of being video recorded, evaluations will be made by a nurse independent of the study.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality group | Experimental | Video recording will be started after the consent is obtained. Physical parameters (peak heart rate, respiratory rate, oxygen saturation) and anxiety of the child will be measured and recorded 1 minute before the procedure. Then, the child will be fitted with virtual reality goggles and inhalation treatment will be started by watching the aquarium and sea creatures video. Inhalation treatment will last for 10 minutes with the most appropriate air flow rate of 6-8 L/min. Then, the virtual reality goggles will be removed and the child's physiological parameters and anxiety will be measured and recorded again after 1 minute. For participants who want to participate in the study but do not approve the video recording, the evaluations will be made by a nurse independent of the study. Receives: Other: virtual reality goggles and inhalation treatment |
| group of distraction cards | Experimental | Video recording will be started after the consent is obtained. One minute before the procedure, the child's physical parameters (peak heart rate, respiratory rate, oxygen saturation) and anxiety will be measured and recorded. Then, the child will be shown the distraction cards and inhalation treatment will be started simultaneously. Playing with the distraction cards will continue for 10 minutes until the end of inhalation treatment. Then, the use of toys will be terminated and the child's physiological parameters and anxiety will be recorded after 1 minute. Video recording will be terminated. For participants who want to participate in the study but do not consent to be video recorded, the evaluations will be carried out by a nurse independent of the study. Receives: Other: distraction cards and inhalation therapy |
| control group | Active comparator | Video recording will be started after the consent is obtained. Physical parameters (peak heart rate, respiratory rate, oxygen saturation) and anxiety of the child will be measured and recorded 1 minute before the procedure. Then, inhalation treatment will be started with routine service practice. The child will receive inhalation treatment for 10 minutes. Physiological parameters and anxiety will be measured and recorded again 1 minute after the procedure. Video recording will be terminated. For participants who want to participate in the study but do not approve the video recording, the evaluations will be made by a nurse independent of the study. Receives: Other: inhalation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Emotional Manifestation Scale-CEMS
This scale was developed by William Li and Lopez in 2003 to assess the anxiety level in children aged 7-12. The Turkish validity and reliability of the scale was conducted by Yanık et al. in 2019, after receiving the approval and opinion of William Li and Lopez regarding the suitability of assessing anxiety in children aged 3-6. The scale has 5 different categories and 25 items and is used to assess the anxiety level of children aged 3-12 during medical interventions. The child's facial expressions are assessed in the facial expression category. Tears are assessed in the vocalization category. Evaluation is made according to the child's body language in the movement category. The child's verbal/nonverbal communication is assessed in the interaction category. The child's active/passive participation is assessed in the cooperation category. Each category is between 1-5 points and a total score of 5-25 points is obtained.
Measured: 1 minute before and 10 minutes after the start of the procedure and for approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Infections, AcuteStudies 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
- Model description
- three groups with traditional therapy control group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Karakaya, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893237
- Sponsor's protocol ID
- UskudarU-SBE-TK-02
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I can share it when necessary, I'm not thinking about it right now.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Goggles and Distraction Cards Applied to Children Aged 6-12 Years During Inhaler Therapy on Physiological Parameters and Anxiety: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06893237
- Acronym / sponsor ID
- UskudarU-SBE-TK-02
- Keywords
- inhalation therapy, child, virtual reality glasses, anxiety, distraction of attention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 25 Mar 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.
In the literature, studies examining the effect of virtual reality application on physiological parameters and anxiety during inhalation therapy, which is frequently used in children, are quite limited. Therefore, this study will be conducted to determine the effect of virtual reality goggles and distraction cards on physiological parameters and anxiety in patients receiving inhalation therapy.
Detailed description
According to the Global Sustainable Development Report, virtual reality (VR) is one of the issues that are expected to bring about major innovations in applications, and this concept was first used by Jaron Lanier towards the end of the 1980s. VR enables computer-generated three-dimensional images and animations to interact with these objects in the environment while giving the feeling of being in a real environment in people's minds with technological tools. The purpose of VR is to make the user believe that they are in the computer-generated environment as much as possible. According to the Turkish Language Association, it is defined as 'a three-dimensional environment created by giving imitations of real environments in a virtual sphere that provides 360-degree vision using artificial intelligence, where unreal environments can be experienced as real, solving complex problems, information transfer, entertainment, etc. It is used for purposes'. Virtual reality technology is used in the field of health as a method of distraction that provides various visual, auditory, tactile and olfactory stimuli and real perceptual stimuli and is applied in many processes related to care and treatment in the health sector, especially in children. Technologies used in health care services accelerate the recovery of patients and provide ease of operation to health professionals. Children encounter many acute or chronic diseases during their developmental period. Hospitalisation as a result of these diseases is complicated and stressful for children and their families and can cause fear, anxiety and anxiety in children. Medical procedures encountered during hospitalisation are the main source of fear for children. They may experience anger, helplessness and anxiety due to reasons such as unfamiliar environment, change in the routine of the child, different sound, light, tools and equipment, unfamiliar people, painful painful procedures, being away from family and friends, loss of control, activity limitation, communication difficulties, presence of other children crying. The use of technology in preparation for or during medical procedures is an effective method in providing anxiety and comfort. Virtual reality is used in injection applications, intravenous interventions, burn dressings and postoperative pain experiences and physiological parameters in children and adolescents. Kurban and Şener investigated the effect of virtual reality goggles applied during vaccination on pain and anxiety in children aged 6-12 years and reported that the VR group had significantly lower pain and anxiety scores. In a systematic review conducted by Nacaroğlu et al. to examine the effect of virtual reality applications on pain and anxiety perception during invasive and painful procedures in school-age children in Turkey, it was reported that VR application positively affected pain and anxiety. In the study conducted by Okay and Okay in 2024 to examine the effect of virtual reality goggles on physiological parameters during inhalation therapy in children aged 2-5 years, it was observed that children watching videos with virtual reality goggles decreased the number of respirations and heart rate per minute, increased oxygen saturation values, decreased crying time and increased treatment efficacy. At the same time, although each child has different interests, it was observed that children experienced less fear and anxiety in studies where calming ocean videos were watched. Respiratory system diseases are frequently seen in childhood and constitute a significant portion of hospital admissions. Respiratory system diseases are an important cause of mortality and morbidity all over the world, a serious public health problem in developed and developing countries, and constitute 8.2% of all disabilities. According to WHO, respiratory tract infections are the most common cause of mortality in children under five years of age and are responsible for 19% of child deaths. According to the data of Turkish Statistical Institute (TurkStat), upper respiratory tract infections (URTI) are the most common disease in the 0-14 age range in our country. Inhalation therapy, which is one of the important methods in the management of respiratory system diseases, is frequently used in paediatric patients to relieve bronchospasm and to relieve the airway by delivering drug particles to the extreme lobes of the lungs. Inhalation therapy is frequently preferred because of its rapid effect, the absence of the need for an intravenous catheter and thus the absence of injection-related pain, the direct effect of the drug on the desired area (lungs), the low side effects on other systems, and the fact that it can be used at any age. Although inhalation treatment with mask is an easy intervention, it is an application that causes fear and anxiety in children. Success in treatment is ensured by the compliance of the child and the family. Children generally do not accept mask treatment and show crying and refusal behaviour. Since the crying of the child during the treatment will reduce intrapulmonary storage, the amount of drug reaching the lungs will decrease and may adversely affect the treatment. At the same time, respiratory distress experienced by children causes anxiety, dyspnoea and increase in respiratory rate. For these reasons, children receiving inhalation therapy should be calm. In order to provide effective inhalation therapy, it is recommended to use evidence-based distraction methods. There are many methods used to divert attention. Some of these are; watching cartoons, hypnotherapy, playing with toys, using virtual reality goggles, music therapy, play therapy, using kaleidoscope and using distraction cards. The method used to divert the attention of paediatric patients should affect both visual and auditory senses and at the same time be appropriate for the development of the child. The aim of the paediatric nurse is to protect and improve the mental, physical, social and spiritual health of the child and to provide holistic care for treatment in the presence of disease. In the literature, studies examining the effect of virtual reality application on physiological parameters and anxiety during inhalation therapy, which is frequently used in children, are quite limited. Therefore, this study will be conducted to determine the effect of virtual reality goggles and distraction cards on physiological parameters and anxiety in patients receiving inhalation therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- three groups with traditional therapy control group.
| Arm | Type | Receives |
|---|---|---|
| virtual reality group | Experimental | Other: virtual reality goggles and inhalation treatmentVideo recording will be started after the consent is obtained. Physical parameters (peak heart rate, respiratory rate, oxygen saturation) and anxiety of the child will be measured and recorded 1 minute before the procedure. Then, the child will be fitted with virtual reality goggles and inhalation treatment will be started by watching the aquarium and sea creatures video. Inhalation treatment will last for 10 minutes with the most appropriate air flow rate of 6-8 L/min. Then, the virtual reality goggles will be removed and the child's physiological parameters and anxiety will be measured and recorded again after 1 minute. For participants who want to participate in the study but do not approve the video recording, the evaluations will be made by a nurse independent of the study. |
| group of distraction cards | Experimental | Other: distraction cards and inhalation therapyVideo recording will be started after the consent is obtained. One minute before the procedure, the child's physical parameters (peak heart rate, respiratory rate, oxygen saturation) and anxiety will be measured and recorded. Then, the child will be shown the distraction cards and inhalation treatment will be started simultaneously. Playing with the distraction cards will continue for 10 minutes until the end of inhalation treatment. Then, the use of toys will be terminated and the child's physiological parameters and anxiety will be recorded after 1 minute. Video recording will be terminated. For participants who want to participate in the study but do not consent to be video recorded, the evaluations will be carried out by a nurse independent of the study. |
| control group | Active comparator | Other: inhalation therapyVideo recording will be started after the consent is obtained. Physical parameters (peak heart rate, respiratory rate, oxygen saturation) and anxiety of the child will be measured and recorded 1 minute before the procedure. Then, inhalation treatment will be started with routine service practice. The child will receive inhalation treatment for 10 minutes. Physiological parameters and anxiety will be measured and recorded again 1 minute after the procedure. Video recording will be terminated. For participants who want to participate in the study but do not approve the video recording, the evaluations will be made by a nurse independent of the study. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The child is receiving inhalation (salbutamol) treatment in the pediatric intensive care unit.
- The child must be between 6-12 years old
- The child must not have any vision or hearing problems.
- Being conscious and being able to communicate verbally
- After being informed, the child and parent agree to participate in the study in writing and verbally
Key exclusion criteria (5 listed)
- The child's clinical treatment is due to a history of surgery,
- The child is taking a sedative medication,
- The child has a fever over 37°C,
- The child has applied with a severe asthma attack,
- The child's saturation value is below 92% at the time of application.
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 |
|---|---|---|
| virtual reality goggles and inhalation treatmentVideo recording will be started after the consent is obtained. One minute before the procedure, the child's physical parameters (peak heart rate, respiratory rate, oxygen saturation) and anxiety will be measured and recorded. Then, the child will be fitted with virtual reality goggles and inhalation treatment will be started by watching the aquarium and sea creatures video. Inhalation treatment will last for 10 minutes with the most appropriate air flow rate of 6-8 L/min. Then, the virtual reality goggles will be removed and the child's physiological parameters and anxiety will be measured and recorded again after 1 minute. For participants who want to participate in the study but do not approve the video recording, the evaluations will be made by a nurse independent of the study. | Other | virtual reality group |
| distraction cards and inhalation therapyAfter the consent is obtained, the video recording will be started. 1 minute before the procedure, the child's physical parameters (heart rate, respiratory rate, oxygen saturation) and anxiety will be measured and recorded. Then, the child will be shown distraction cards and inhalation therapy will be started simultaneously. Playing with the distraction cards will continue for 10 minutes until the end of the inhalation therapy. Then, the use of the toys will be stopped and the child's physiological parameters and anxiety will be recorded after 1 minute. The video recording will be ended. For participants who want to participate in the study but do not consent to being video recorded, the evaluations will be made by a nurse independent of the study. | Other | group of distraction cards |
| inhalation therapyAfter the consent is received, the video recording will be started. 1 minute before the procedure, the child's physical parameters (heart rate, respiratory rate, oxygen saturation) and anxiety will be measured and recorded. Then, inhalation therapy will be started with routine service application. The child will receive inhalation therapy for 10 minutes. 1 minute after the procedure, physiological parameters and anxiety will be measured and recorded again. The video recording will be ended. For participants who want to participate in the study but do not approve of being video recorded, evaluations will be made by a nurse independent of the study. | Other | control group |
Primary outcome
Children's Emotional Manifestation Scale-CEMS
Time frame: 1 minute before and 10 minutes after the start of the procedure and for approximately 1 year
This scale was developed by William Li and Lopez in 2003 to assess the anxiety level in children aged 7-12. The Turkish validity and reliability of the scale was conducted by Yanık et al. in 2019, after receiving the approval and opinion of William Li and Lopez regarding the suitability of assessing anxiety in children aged 3-6. The scale has 5 different categories and 25 items and is used to assess the anxiety level of children aged 3-12 during medical interventions. The child's facial expressions are assessed in the facial expression category. Tears are assessed in the vocalization category. Evaluation is made according to the child's body language in the movement category. The child's verbal/nonverbal communication is assessed in the interaction category. The child's active/passive participation is assessed in the cooperation category. Each category is between 1-5 points and a total score of 5-25 points is obtained.
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 30 Mar 2025.
- Individual participant dataSharing planned: No. I can share it when necessary, I'm not thinking about it right now.
Related trials for Respiratory Infections, Acute
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality goggles and inhalation treatment, distraction cards and inhalation therapy and inhalation therapy in people with Respiratory Infections, Acute and Respiratory Tract Diseases, run by Uskudar University.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Children's Emotional Manifestation Scale-CEMS (time frame: 1 minute before and 10 minutes after the start of the procedure and for approximately 1 year). 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 30 Mar 2025.