InhalationINHALATIONNCT06197646
Inhalation Therapy and Therapeutic Play
A study testing Cartoon characters inhaler mask in people with Inhalation and Respiratory Disease, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical research study was to determine the effect of the use of a cartoon character mask on treatment compliance and parental satisfaction and to evaluate the effectiveness of the cartoon character mask in children receiving inhaled therapy for the treatment of respiratory system diseases in… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Inhalation, Respiratory Disease
- What is being tested?
- Cartoon characters inhaler mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Jul 2024
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being between the ages of 3-12
- Being in a pediatric clinic
- Being diagnosed with respiratory system diseases
- Being on inhaler therapy as part of routine treatment
- Self and parent's consent to participate in the study
Who cannot join
- Having a cognitive or neurological problem
- Not taking inhaler therapy routinely
- Being a foreign national
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye University
Istanbul, Zeytınburnu, 34010
About this study
Official title: The Effect of Using Masks With Cartoon Heroes on Treatment Compliance and Parental Satisfaction in Inhaler Therapy Applications in Children
The aim of this clinical research study was to determine the effect of the use of a cartoon character mask on treatment compliance and parental satisfaction and to evaluate the effectiveness of the cartoon character mask in children receiving inhaled therapy for the treatment of respiratory system diseases in children.
The hypotheses it aims to answer are as follows:
Read more
H1: Inhalers given using a mask with a cartoon character facilitate treatment compliance.
H2: The inhaler given using a mask with a cartoon character makes treatment compliance difficult.
H3: Inhaler treatment using a mask with a cartoon hero increases parental satisfaction.
H4: Inhaler treatment using a mask with a cartoon hero decreases parental satisfaction.
H5: Inhaler treatment using a mask with a cartoon hero has a positive effect on the hospitalization process.
H6: Inhaler treatment using a mask with a cartoon hero has a positive effect on the recovery process.
H7: Compared to routine inhaler mask use, the use of masks with cartoon heroes provides a positive relationship between treatment adherence and parental satisfaction.
In the study, according to randomization, the intervention group will receive inhalers with masks, and the other group will receive inhalers routinely used in the clinic. The treatment of the children was planned by the physician, and no additional treatment was given for the study. Children's adherence to treatment and parents; satisfaction will be evaluated. The effectiveness of the masked inhaler used will be asked.
Read the detailed description
Respiratory diseases are among the most common diseases in childhood and are among the most important causes of infectious disease-related mortality and morbidity worldwide. Approximately 1 in 3 children have a lower respiratory tract infection in the first year of life. Respiratory tract infections are more common in developing countries and have a worse prognosis. According to World Health Organization data, respiratory tract infections constitute 13% of the causes of mortality in children under 5 years of age. Respiratory tract diseases are frequently seen during seasonal transitions in childhood and are caused by viral or bacterial agents. Treatment of respiratory tract diseases differs as outpatient or inpatient depending on the agent and the condition of the child. In addition to antibiotherapy, relaxing and supportive treatments are also included in the treatment. These include analgesics, antipyretics, decongestants, and antihistamines. These treatments are administered orally, parenterally, or inhaled. In inhaler treatment, medication is given by placing it into a pediatric mask with a reservoir. This treatment method is boring, frightening, and anxiety-inducing for the pediatric age group and makes it difficult to comply with the treatment. Various methods are being tried to facilitate compliance with treatment in children. One of these methods is play-based treatment activities.
Play is a form of learning that facilitates children's adaptation to the outside world by providing them with new experiences, skills, and social responsibility, and enables them to communicate by exploring their environment. Play is defined by the United Nations High Commission for Human Rights as the right of every child that contributes to the development of the child. In the literature, it is reported that play is effective in reducing the anxiety and fear of hospitalized children and is necessary to provide holistic and quality care. It has also been reported that it does not benefit their recovery by relaxing them both physically and emotionally.
Games are categorized under four headings according to their purpose: entertaining and distracting games, games that support the development of cognitive, social, and sensorimotor skills, games that teach right and wrong, provide socialization, make people aware of and accept their biological existence as men or women, and therapeutic games to relieve anxiety and tension. Games can be used in clinics as healing practices (therapeutic practices). Although therapeutic play and play therapy are used interchangeably, they are conceptually and practically quite different. The spontaneous creation of activities using toys without predetermined goals is referred to as play therapy.
Therapeutic play that activates physiological functions is used in cases where the child exhibits regressive behavior, drama therapeutic play that allows emotional discharge, and educational/creative therapeutic play is used to prepare children for procedures.
There are three types of therapeutic play:
- Energy Expending Play: Children show their aggressive behavior, anger, and anxiety by shouting, punching, and running. To direct these emotions in the hospital, areas for this purpose should be created or appropriate materials should be provided. In this way, their aggressive behavior, anger, and anxiety levels can be reduced.
- Dramatic Play: Playing by imitating life and events to understand them better is defined as dramatic play. By using dramatic play, it is ensured that the child expresses his/her feelings about the interventions to be applied in the hospital environment and major events. For this purpose, playing with medical equipment such as masks, stethoscopes, and IV sets during the game can be effective in reducing the stress of children and expressing what they feel.
- Creative Play: This is the type of play used to show children how each procedure is done by using materials before and after the procedures. In creative play, methods such as drawing pictures, sentence completion, and three wishes tests are used to collect information about the inner world of the child.
The main aim of the therapeutic relationship in pediatric nursing is to maintain the health, growth, and development of the child and his/her family at the highest possible level. Nurses help children and their parents to maintain their health and develop adaptation by gaining effective coping skills in case of illness or any lifestyle change.
Nurses can use play as a health care strategy for hospitalized children in three areas. The first of these areas is its use in routine practices. Secondly, it is recommended to use it in preparation for surgical or invasive interventions and finally during painful and unpleasant procedures.
For nurses, play is key to understanding the child. Therapeutic play helps children to express their feelings and thoughts verbally or non-verbally about the procedures to be applied. The nurse adapts therapeutic play to care and provides nursing care in line with the information gathered through play. Florence Nightingale, the founder of modern nursing, emphasized the necessity of play for hospitalized children. Studies have reported that therapeutic play practice contributes to holistic and specific nursing care and that therapeutic play is an effective method. However, it was found that most of them did not use it in daily nursing practices due to reasons such as lack of time.
In the last decade, it has been known that showing videos and distributing booklets and coloring books to children at the pre-anesthetic visit is beneficial. Arranging the anesthesia mask to resemble popular characters among children (such as birds, and cartoon characters), having children put the masks on their faces and look at the fun face mask in the mirror and blowing on the balloon, making it look like a magic ball, allowing children to stick the stickers they like on the anesthesia mask as a game facilitates induction of anesthesia. With pharmacological premedication appropriate to these nonpharmacological methods, anxiety can be prevented, psychological injuries can be reduced, induction of anesthesia can be facilitated, and preoperative anxiety of the child can be reduced.
- Conditions
- Inhalation, Respiratory Disease
- Being tested
- Cartoon characters inhaler mask
- Keywords
- inhaler therapy, children, inhalation, therapeutic play, nursing
- Medical subject headings
- Respiratory Aspiration, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cartoon characters inhaler maskDevice
Cartoon characters inhaler mask
| Study group | Role | What they receive |
|---|---|---|
| Inhaler mask with cartoon characters | Experimental | Inhalation therapy with cartoon characters inhaler mask and Inhaler therapy training Receives: Device: Cartoon characters inhaler mask |
| Inhaler mask | No intervention | Inhalation therapy with the inhaler mask routinely used by the clinic and Inhaler therapy training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment compliance
The primary outcome of the study will be to determine children's compliance with inhalation therapy with an inhaler mask.
Measured: 6 months
Secondary outcomes (1)
Effectiveness and usefulness of the treatment tool
As a secondary result, the effectiveness and usefulness of the cartoon character mask developed within the framework of therapeutic play will be evaluated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Aug 2023
- Primary completion1 Nov 2023
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for InhalationStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aysegul Simsek, Study director, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197646
- Sponsor's protocol ID
- 23/185
- Acronym
- INHALATION
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once completed, the study will be published in a scientific journal. After publication, IPD will be shared upon request. Researchers will have access to the IPD. The materials and methods section will be shared upon reasonable request.
Publications
undefined
Gül, O. (2015). The effect of game on pre-school period (ages 3-6): A review of study. Turkish Journal of Sport and Exercise, 17(3), 1. https://doi.org/10.15314/tjse.
Ginsburg KR; American Academy of Pediatrics Committee on Communications; American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health. The importance of play in promoting healthy child development and maintaining strong parent-child bonds. Pediatrics. 2007 Jan;119(1):182-91. doi: 10.1542/peds.2006-2697.
PubMed 17200287Francischinelli, A. G., Almeida, F. A. &, & Fernandes, M. S. (2012). Routine use of therapeutic play in the care of hospitalized children: nurses' perceptions. Acta Paul Enferm, 25(1), 18-23. https://doi.org/10.1590/S0103- 21002012000100004
Çavuşoğlu H. (2013). Child Health Nursing. Ankara: System Ofset Printing House: p. 67-69
Çiftçi, E. N. (2011). The effect of visual and auditory premedication on mask induction in children. Trakya University, Faculty of Medicine, Specialization Thesis (Advisor Sevtap Hekimoğlu Şahin), Edirne.
Berna, I. K., Ceren, Ç., & Esenay Figen. (2013). Therapeutic play: the key to communication with the sick child. Ankara Journal of Health Sciences, 2(123), 1-10. https://doi.org/10.1501/Asbd_0000000038
Aydin T, Sahin L, Algin C, Kabay S, Yucel M, Hacioglu A, Yaylak F, Kilicoglu A. Do not mask the mask: use it as a premedicant. Paediatr Anaesth. 2008 Feb;18(2):107-12. doi: 10.1111/j.1460-9592.2007.02381.x.
PubMed 18184240Altay, N. C. (2008). Preoperative preparation in children. Hacettepe University Faculty of Health Sciences Nursing Journal, 68-76.
Koukourikos K, Tzeha L, Pantelidou P, Tsaloglidou A. THE IMPORTANCE OF PLAY DURING HOSPITALIZATION OF CHILDREN. Mater Sociomed. 2015 Dec;27(6):438-41. doi: 10.5455/msm.2015.27.438-441.
PubMed 26889107
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Masks With Cartoon Heroes on Treatment Compliance and Parental Satisfaction in Inhaler Therapy Applications in Children
- ClinicalTrials.gov ID
- NCT06197646
- Acronym / sponsor ID
- INHALATION / 23/185
- Conditions
- Inhalation, Respiratory Disease
- Keywords
- inhaler therapy, children, inhalation, therapeutic play, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 9 Jan 2024 (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 this clinical research study was to determine the effect of the use of a cartoon character mask on treatment compliance and parental satisfaction and to evaluate the effectiveness of the cartoon character mask in children receiving inhaled therapy for the treatment of respiratory system diseases in children.
The hypotheses it aims to answer are as follows:
H1: Inhalers given using a mask with a cartoon character facilitate treatment compliance.
H2: The inhaler given using a mask with a cartoon character makes treatment compliance difficult.
H3: Inhaler treatment using a mask with a cartoon hero increases parental satisfaction.
H4: Inhaler treatment using a mask with a cartoon hero decreases parental satisfaction.
H5: Inhaler treatment using a mask with a cartoon hero has a positive effect on the hospitalization process.
H6: Inhaler treatment using a mask with a cartoon hero has a positive effect on the recovery process.
H7: Compared to routine inhaler mask use, the use of masks with cartoon heroes provides a positive relationship between treatment adherence and parental satisfaction.
In the study, according to randomization, the intervention group will receive inhalers with masks, and the other group will receive inhalers routinely used in the clinic. The treatment of the children was planned by the physician, and no additional treatment was given for the study. Children's adherence to treatment and parents; satisfaction will be evaluated. The effectiveness of the masked inhaler used will be asked.
Detailed description
Respiratory diseases are among the most common diseases in childhood and are among the most important causes of infectious disease-related mortality and morbidity worldwide. Approximately 1 in 3 children have a lower respiratory tract infection in the first year of life. Respiratory tract infections are more common in developing countries and have a worse prognosis. According to World Health Organization data, respiratory tract infections constitute 13% of the causes of mortality in children under 5 years of age. Respiratory tract diseases are frequently seen during seasonal transitions in childhood and are caused by viral or bacterial agents. Treatment of respiratory tract diseases differs as outpatient or inpatient depending on the agent and the condition of the child. In addition to antibiotherapy, relaxing and supportive treatments are also included in the treatment. These include analgesics, antipyretics, decongestants, and antihistamines. These treatments are administered orally, parenterally, or inhaled. In inhaler treatment, medication is given by placing it into a pediatric mask with a reservoir. This treatment method is boring, frightening, and anxiety-inducing for the pediatric age group and makes it difficult to comply with the treatment. Various methods are being tried to facilitate compliance with treatment in children. One of these methods is play-based treatment activities.
Play is a form of learning that facilitates children's adaptation to the outside world by providing them with new experiences, skills, and social responsibility, and enables them to communicate by exploring their environment. Play is defined by the United Nations High Commission for Human Rights as the right of every child that contributes to the development of the child. In the literature, it is reported that play is effective in reducing the anxiety and fear of hospitalized children and is necessary to provide holistic and quality care. It has also been reported that it does not benefit their recovery by relaxing them both physically and emotionally.
Games are categorized under four headings according to their purpose: entertaining and distracting games, games that support the development of cognitive, social, and sensorimotor skills, games that teach right and wrong, provide socialization, make people aware of and accept their biological existence as men or women, and therapeutic games to relieve anxiety and tension. Games can be used in clinics as healing practices (therapeutic practices). Although therapeutic play and play therapy are used interchangeably, they are conceptually and practically quite different. The spontaneous creation of activities using toys without predetermined goals is referred to as play therapy.
Therapeutic play that activates physiological functions is used in cases where the child exhibits regressive behavior, drama therapeutic play that allows emotional discharge, and educational/creative therapeutic play is used to prepare children for procedures.
There are three types of therapeutic play:
- Energy Expending Play: Children show their aggressive behavior, anger, and anxiety by shouting, punching, and running. To direct these emotions in the hospital, areas for this purpose should be created or appropriate materials should be provided. In this way, their aggressive behavior, anger, and anxiety levels can be reduced.
- Dramatic Play: Playing by imitating life and events to understand them better is defined as dramatic play. By using dramatic play, it is ensured that the child expresses his/her feelings about the interventions to be applied in the hospital environment and major events. For this purpose, playing with medical equipment such as masks, stethoscopes, and IV sets during the game can be effective in reducing the stress of children and expressing what they feel.
- Creative Play: This is the type of play used to show children how each procedure is done by using materials before and after the procedures. In creative play, methods such as drawing pictures, sentence completion, and three wishes tests are used to collect information about the inner world of the child.
The main aim of the therapeutic relationship in pediatric nursing is to maintain the health, growth, and development of the child and his/her family at the highest possible level. Nurses help children and their parents to maintain their health and develop adaptation by gaining effective coping skills in case of illness or any lifestyle change.
Nurses can use play as a health care strategy for hospitalized children in three areas. The first of these areas is its use in routine practices. Secondly, it is recommended to use it in preparation for surgical or invasive interventions and finally during painful and unpleasant procedures.
For nurses, play is key to understanding the child. Therapeutic play helps children to express their feelings and thoughts verbally or non-verbally about the procedures to be applied. The nurse adapts therapeutic play to care and provides nursing care in line with the information gathered through play. Florence Nightingale, the founder of modern nursing, emphasized the necessity of play for hospitalized children. Studies have reported that therapeutic play practice contributes to holistic and specific nursing care and that therapeutic play is an effective method. However, it was found that most of them did not use it in daily nursing practices due to reasons such as lack of time.
In the last decade, it has been known that showing videos and distributing booklets and coloring books to children at the pre-anesthetic visit is beneficial. Arranging the anesthesia mask to resemble popular characters among children (such as birds, and cartoon characters), having children put the masks on their faces and look at the fun face mask in the mirror and blowing on the balloon, making it look like a magic ball, allowing children to stick the stickers they like on the anesthesia mask as a game facilitates induction of anesthesia. With pharmacological premedication appropriate to these nonpharmacological methods, anxiety can be prevented, psychological injuries can be reduced, induction of anesthesia can be facilitated, and preoperative anxiety of the child can be reduced.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Inhaler mask with cartoon characters | Experimental | Device: Cartoon characters inhaler maskInhalation therapy with cartoon characters inhaler mask and Inhaler therapy training |
| Inhaler mask | No intervention | –Inhalation therapy with the inhaler mask routinely used by the clinic and Inhaler therapy training |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Being between the ages of 3-12
- Being in a pediatric clinic
- Being diagnosed with respiratory system diseases
- Being on inhaler therapy as part of routine treatment
- Self and parent's consent to participate in the study
Key exclusion criteria (3 listed)
- Having a cognitive or neurological problem
- Not taking inhaler therapy routinely
- Being a foreign national
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 |
|---|---|---|
| Cartoon characters inhaler maskCartoon characters inhaler mask | Device | Inhaler mask with cartoon characters |
Primary outcome
Treatment compliance
Time frame: 6 months
The primary outcome of the study will be to determine children's compliance with inhalation therapy with an inhaler mask.
1 secondary outcome
Effectiveness and usefulness of the treatment tool
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Backgroundundefined
- BackgroundGül, O. (2015). The effect of game on pre-school period (ages 3-6): A review of study. Turkish Journal of Sport and Exercise, 17(3), 1. https://doi.org/10.15314/tjse.
- Background: PubMed 17200287Ginsburg KR; American Academy of Pediatrics Committee on Communications; American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health. The importance of play in promoting healthy child development and maintaining strong parent-child bonds. Pediatrics. 2007 Jan;119(1):182-91. doi: 10.1542/peds.2006-2697.
- BackgroundFrancischinelli, A. G., Almeida, F. A. &, & Fernandes, M. S. (2012). Routine use of therapeutic play in the care of hospitalized children: nurses' perceptions. Acta Paul Enferm, 25(1), 18-23. https://doi.org/10.1590/S0103- 21002012000100004
- BackgroundÇavuşoğlu H. (2013). Child Health Nursing. Ankara: System Ofset Printing House: p. 67-69
- BackgroundÇiftçi, E. N. (2011). The effect of visual and auditory premedication on mask induction in children. Trakya University, Faculty of Medicine, Specialization Thesis (Advisor Sevtap Hekimoğlu Şahin), Edirne.
- BackgroundBerna, I. K., Ceren, Ç., & Esenay Figen. (2013). Therapeutic play: the key to communication with the sick child. Ankara Journal of Health Sciences, 2(123), 1-10. https://doi.org/10.1501/Asbd_0000000038
- Background: PubMed 18184240Aydin T, Sahin L, Algin C, Kabay S, Yucel M, Hacioglu A, Yaylak F, Kilicoglu A. Do not mask the mask: use it as a premedicant. Paediatr Anaesth. 2008 Feb;18(2):107-12. doi: 10.1111/j.1460-9592.2007.02381.x.
- BackgroundAltay, N. C. (2008). Preoperative preparation in children. Hacettepe University Faculty of Health Sciences Nursing Journal, 68-76.
- Results publication: PubMed 26889107Koukourikos K, Tzeha L, Pantelidou P, Tsaloglidou A. THE IMPORTANCE OF PLAY DURING HOSPITALIZATION OF CHILDREN. Mater Sociomed. 2015 Dec;27(6):438-41. doi: 10.5455/msm.2015.27.438-441.
- Individual participant dataSharing planned: No. Once completed, the study will be published in a scientific journal. After publication, IPD will be shared upon request. Researchers will have access to the IPD. The materials and methods section will be shared upon reasonable request.
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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.
Aysegul Simsek study director
Istinye University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cartoon characters inhaler mask in people with Inhalation and Respiratory Disease, run by Istinye 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 2 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment compliance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06197646, which also lists 10 linked publications.
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 2 May 2025.