Children With Liver TransplantNCT05420025
VIRTUAL REALITY GLASSES, CHILDREN WITH LIVER TRANSPLANTATION
A study of Children With Liver Transplant, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to determine the effect of SGG application on pain, anxiety/anxiety, fear and physiological variables during dressing in children aged 4-10 years with liver transplantation. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Children With Liver Transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Apr 2022to 27 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between the ages of 4-10,
- do not have a chronic or genetic disease,
- not mentally, visually or hearing impaired,
- no painful intervention is applied at least one hour before the dressing,
- no analgesic and sedative applied at least one hour before the dressing,
- both himself and his parents are open to communication and cooperation,
- Children who are first dressed in the service, who both themselves and their parents volunteer to participate in the study, and who give verbal and written consent will be included.
Who cannot join
- Children who cannot adapt to the virtual reality glasses during the study, who are restless and who want to withdraw from the study will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Firat University
Elâzığ, 23200
Semiha Dertli, 05074923120, semihadertli15@gmail.com
About this study
Official title: THE EFFECT OF VIRTUAL REALITY GLASSES APPLICATION ON PAIN ANXIETY FEAR AND PHYSIOLOGICAL PARAMETERS OCCURING DURING DRESSING CHANGE IN CHILDREN WITH LIVER TRANSPLANT
The aim of the study is to determine the effect of SGG application on pain, anxiety/anxiety, fear and physiological variables during dressing in children aged 4-10 years with liver transplantation.
Children with liver transplantation are in the whole treatment and care process; exposed to frequent and repetitive painful procedures. Abdominal dressings were observed to be the most frequent-repetitive, long-term source of pain affecting children physically and psychologically from these procedures. It is thought that the use of virtual reality during abdominal dressing will be beneficial because of the size of the abdominal incision and dressings, the use of no analgesic or sedative agent during dressing, and the children are affected by this incision image. It is thought that virtual reality can be used and effective in this area in terms of keeping people away from images and sounds and isolating them from real life.
Read the detailed description
Liver transplantation is becoming widespread as an effective treatment option. Medical and technological developments have affected the increase in the number and success rate of transplant patients. On the other hand, some physiological and psychological problems occur in children during and after transplantation. It is stated that the biggest source of fear for children in the hospital is invasive procedures such as blood draw, injection, and post-operative dressing change. These interventions, which are accepted as treatment and care procedures and which must be performed, are defined as procedural sources of pain. Dressing changes after abdominal surgery can cause the child to experience pain and fear. Although it is known that procedural pain is physiological, it is thought that the fear and anxiety that arise during this time also cause pain. The pain experienced by children during dressing change and the inability to effectively manage this pain; It can disrupt the secretion of hormones and permanently change the function and arrangement of some organs. It can prolong hospital stay by causing deterioration in glucose balance and delay in wound healing. Procedural pain management aims to minimize the pain and anxiety experienced by children due to medical interventions. For this purpose, it is recommended to use non-pharmacological methods in addition to pharmacological treatment methods. One of the most preferred non-pharmacological methods in children is distraction. Unlike other methods of distraction, virtual reality is a different method in that it distances the person from images and sounds, isolates them from real life, brings together multiple sensory experiences and maximizes the sense of attention. In the treatment and care process of children with liver transplantation; exposed to frequent and repetitive painful procedures. Abdominal dressings were observed to be the most frequent-repetitive, long-term source of pain affecting children physically and psychologically from these procedures. It is thought that the use of virtual reality during abdominal dressing will be beneficial because of the size of the abdominal incision and dressings, the use of an analgesic/sedative agent during dressing, and the fact that children are affected by this incision image.
The aim of the study was to determine the effect of SGG application on pain, anxiety/anxiety, fear and physiological variables during dressing in children aged 4-10 years who had liver transplantation.
- Conditions
- Children With Liver Transplant
- Keywords
- Liver transplantation, Virtual Reality, Pain, Anxiety, Fear, Dressing chang, Child
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| CHILDREN APPLIED WITH VIRTUAL REALITY GLASSES | Experimental | Before the first dressing (5 minutes before the dressing) of the children who were accepted to the Organ Transplantation A Service from the intensive care unit after the transplantation, the introductory characteristics form and scales will be applied and the physiological parameters of the child (heart rate, respiratory rate, blood pressure) will be applied by the researcher. , oxygen saturation) will be taken. Then the children will be put on SGG and the glasses will be synchronized. During the dressing, children will be shown a video with SGG, which received expert opinion beforehand. After the dressing, the physiological parameters of the children will be measured again and the scales will be applied again. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faces Pain Scale-Revised (FPSR)
Hicks et al. (2001) Revised Facial Expressions Pain Scale (R-FAS) is a self-expression-based scale that can be applied to children aged 4-16. The scale consists of 6 facial expressions graded from 0 to 10 according to the severity of the pain. The R-FLPS, which can be understood easily and quickly with the explanation given to children, has been translated into more than 35 languages. Values between 1-3 indicate mild pain, values between 4-6 indicate moderate pain, and values between 7-10 indicate severe pain.
Measured: 5- 10 min
Child Anxiety Scale-State Scale (CAS-D)
CAS-D is a visual scale for children aged 4-10 years. With a light bulb at the bottom and ten horizontal lines running towards the top, this visual scale resembles a thermometer. While applying the scale; children "Imagine that all of your anxious or nervous feelings are on the bulb or the top of the thermometer (point with your finger on the scale)", "If you are even slightly worried or nervous, the emotions may increase a little (point your finger up on the scale)", "Very, very worried or If you are nervous, the emotions may go all the way to the top of the lines (move your finger to the top), instructions such as "Put a line to let us know how anxious or nervous you are feeling." Following the data collection process, the research team members followed the child's "ÇAS-D " and a transparent meter with ½ point increments is placed over the child's rating and the ½ point increment is rounded to the nearest number to determine the child's score. The score can range from 0-10.
Measured: 5-10 min
Child Fear Scale (CFS)
The Child Fear Scale (CDS), developed by McMurtry et al., is used to evaluate the fear levels of children aged 4-10 (32). 5 cartoon face images were used in the scale. Anxiety level is evaluated with numbers between "0" and "4". A score of "0" indicates "no anxiety" and a score of "4" indicates "severe anxiety". Validity and reliability of the scale Özalp-Geker et al. Made by in 2018. The scope validity index is 0.89.
Measured: 5-10 Min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start26 Apr 2022
- Primary completion25 Feb 2023 (estimated)
- Study completion27 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Liver TransplantStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi Experimental
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semiha Dertli, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420025
- Sponsor's protocol ID
- Firat Universityyyyyyyyyyy
- Other IDs
- Emine ERDEM, Tevfik Tolga SAHIN
- Status last verified
- Dec 2022
- First submitted
- 11 Jun 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF VIRTUAL REALITY GLASSES APPLICATION ON PAIN ANXIETY FEAR AND PHYSIOLOGICAL PARAMETERS OCCURING DURING DRESSING CHANGE IN CHILDREN WITH LIVER TRANSPLANT
- ClinicalTrials.gov ID
- NCT05420025
- Acronym / sponsor ID
- Firat Universityyyyyyyyyyy
- Conditions
- Children With Liver Transplant
- Keywords
- Liver transplantation, Virtual Reality, Pain, Anxiety, Fear, Dressing chang, Child
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 25 Feb 2023 (estimated)
- Study completion
- 27 May 2023 (estimated)
- First posted
- 15 Jun 2022 (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.
The aim of the study is to determine the effect of SGG application on pain, anxiety/anxiety, fear and physiological variables during dressing in children aged 4-10 years with liver transplantation.
Children with liver transplantation are in the whole treatment and care process; exposed to frequent and repetitive painful procedures. Abdominal dressings were observed to be the most frequent-repetitive, long-term source of pain affecting children physically and psychologically from these procedures. It is thought that the use of virtual reality during abdominal dressing will be beneficial because of the size of the abdominal incision and dressings, the use of no analgesic or sedative agent during dressing, and the children are affected by this incision image. It is thought that virtual reality can be used and effective in this area in terms of keeping people away from images and sounds and isolating them from real life.
Detailed description
Liver transplantation is becoming widespread as an effective treatment option. Medical and technological developments have affected the increase in the number and success rate of transplant patients. On the other hand, some physiological and psychological problems occur in children during and after transplantation. It is stated that the biggest source of fear for children in the hospital is invasive procedures such as blood draw, injection, and post-operative dressing change. These interventions, which are accepted as treatment and care procedures and which must be performed, are defined as procedural sources of pain. Dressing changes after abdominal surgery can cause the child to experience pain and fear. Although it is known that procedural pain is physiological, it is thought that the fear and anxiety that arise during this time also cause pain. The pain experienced by children during dressing change and the inability to effectively manage this pain; It can disrupt the secretion of hormones and permanently change the function and arrangement of some organs. It can prolong hospital stay by causing deterioration in glucose balance and delay in wound healing. Procedural pain management aims to minimize the pain and anxiety experienced by children due to medical interventions. For this purpose, it is recommended to use non-pharmacological methods in addition to pharmacological treatment methods. One of the most preferred non-pharmacological methods in children is distraction. Unlike other methods of distraction, virtual reality is a different method in that it distances the person from images and sounds, isolates them from real life, brings together multiple sensory experiences and maximizes the sense of attention. In the treatment and care process of children with liver transplantation; exposed to frequent and repetitive painful procedures. Abdominal dressings were observed to be the most frequent-repetitive, long-term source of pain affecting children physically and psychologically from these procedures. It is thought that the use of virtual reality during abdominal dressing will be beneficial because of the size of the abdominal incision and dressings, the use of an analgesic/sedative agent during dressing, and the fact that children are affected by this incision image.
The aim of the study was to determine the effect of SGG application on pain, anxiety/anxiety, fear and physiological variables during dressing in children aged 4-10 years who had liver transplantation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi Experimental
| Arm | Type | Receives |
|---|---|---|
| CHILDREN APPLIED WITH VIRTUAL REALITY GLASSES | Experimental | –Before the first dressing (5 minutes before the dressing) of the children who were accepted to the Organ Transplantation A Service from the intensive care unit after the transplantation, the introductory characteristics form and scales will be applied and the physiological parameters of the child (heart rate, respiratory rate, blood pressure) will be applied by the researcher. , oxygen saturation) will be taken. Then the children will be put on SGG and the glasses will be synchronized. During the dressing, children will be shown a video with SGG, which received expert opinion beforehand. After the dressing, the physiological parameters of the children will be measured again and the scales will be applied again. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Between the ages of 4-10,
- do not have a chronic or genetic disease,
- not mentally, visually or hearing impaired,
- no painful intervention is applied at least one hour before the dressing,
- no analgesic and sedative applied at least one hour before the dressing,
Key exclusion criteria (1 listed)
- Children who cannot adapt to the virtual reality glasses during the study, who are restless and who want to withdraw from the study will be excluded from the study.
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 |
|---|---|---|
| Other | CHILDREN APPLIED WITH VIRTUAL REALITY GLASSES |
Primary outcome
Faces Pain Scale-Revised (FPSR)
Time frame: 5- 10 min
Hicks et al. (2001) Revised Facial Expressions Pain Scale (R-FAS) is a self-expression-based scale that can be applied to children aged 4-16. The scale consists of 6 facial expressions graded from 0 to 10 according to the severity of the pain. The R-FLPS, which can be understood easily and quickly with the explanation given to children, has been translated into more than 35 languages. Values between 1-3 indicate mild pain, values between 4-6 indicate moderate pain, and values between 7-10 indicate severe pain.
Child Anxiety Scale-State Scale (CAS-D)
Time frame: 5-10 min
CAS-D is a visual scale for children aged 4-10 years. With a light bulb at the bottom and ten horizontal lines running towards the top, this visual scale resembles a thermometer. While applying the scale; children "Imagine that all of your anxious or nervous feelings are on the bulb or the top of the thermometer (point with your finger on the scale)", "If you are even slightly worried or nervous, the emotions may increase a little (point your finger up on the scale)", "Very, very worried or If you are nervous, the emotions may go all the way to the top of the lines (move your finger to the top), instructions such as "Put a line to let us know how anxious or nervous you are feeling." Following the data collection process, the research team members followed the child's "ÇAS-D " and a transparent meter with ½ point increments is placed over the child's rating and the ½ point increment is rounded to the nearest number to determine the child's score. The score can range from 0-10.
Child Fear Scale (CFS)
Time frame: 5-10 Min
The Child Fear Scale (CDS), developed by McMurtry et al., is used to evaluate the fear levels of children aged 4-10 (32). 5 cartoon face images were used in the scale. Anxiety level is evaluated with numbers between "0" and "4". A score of "0" indicates "no anxiety" and a score of "4" indicates "severe anxiety". Validity and reliability of the scale Özalp-Geker et al. Made by in 2018. The scope validity index is 0.89.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Children With Liver Transplant, run by Firat University 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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Semiha Dertli, RA (05074923120, semihadertli15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faces Pain Scale-Revised (FPSR) (time frame: 5- 10 min). The study lists 3 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 6 Dec 2022.