Nurse's RoleNCT05664503
The Effect of Mobile Health Education on Adaptation to Stoma, Self-efficacy, and Peristomal Lesions
A study testing Assigned Interventions STOMA-M in people with Nurse's Role and Patient Compliance, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
To explore the effect of the Stoma Mobile application-based training method on the psychosocial adjustment, self-efficacy, and development of peristomal skin complications in individuals with a stoma. Quasi-experimental study with a post-test control group. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role, Patient Compliance, Peristomal Skin Complication
- What is being tested?
- Assigned Interventions STOMA-M
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Nov 2020to 20 Dec 2021
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Literate,
- Without any physical and psychological disabilities,
- Able to use smartphones
- Willing to participate in the study.
Who cannot join
- Patients who were in the same room or underwent a urostomy were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mobile Health Education on Adaptation to Stoma, Self-efficacy, and Peristomal Skin Lesions: A Quasi-experimental Study
To explore the effect of the Stoma Mobile application-based training method on the psychosocial adjustment, self-efficacy, and development of peristomal skin complications in individuals with a stoma.
Quasi-experimental study with a post-test control group. Patients who met the inclusion criteria were randomly selected. While the experimental group (n=30) received training with the Stoma Mobile application, the control group (n=30) received training with the booklet. Stoma compliance, self-efficacy level, and the presence of complications were compared in both groups in the first and third months after discharge.
Read more
H11: Individuals who receive stoma care training via STOMA-M will have a higher adaptation to stomas than individuals who receive stoma care training via a booklet.
H12: The SE levels of individuals who receive stoma care training via STOMA-M will be higher than those who receive stoma care training via a booklet.
H13: Peristomal skin complications of individuals who receive stoma care training via STOMA-M will be lower than those who receive stoma care training via a booklet.
The population of the study included patients who had a stoma for the first time, were in a university hospital in Istanbul between December 2020 and December 2021, and who were 18 years of age and older, literate, without any physical and psychological disabilities, able to use smartphones, and willing to participate in the study. Patients who were in the same room or underwent a urostomy were not included in the study.
The experimental group using the Stoma Health Mobile application had higher psychosocial adjustment and self-efficacy scores than the control group, and the peristomal skin lesion complication rate was lower than that of the control group. Social self-efficacy positively affects stoma compliance, and the Stoma Mobile application positively affects the level of social self-efficacy and adaptation of ostomates to the stoma
Read the detailed description
Ostomates need to learn to cope with new self-care routines and emotional problems related to changes in body image and self-perception. This learning process is defined as psychosocial adjustment. Adaptation of the patient to the stoma after surgery is part of the process in which the patient re-coordinates the body, self, and external world. In addition to the follow-up process after surgical treatments, psychosocial adjustment is one of the most important factors that define SE and quality of life.
Bandura (1994) defines SE as the belief that people can effectively initiate the necessary activities and reach results in events related to their lives. In other words, SE is a dynamic cognitive process that expresses the confidence of individuals with a stoma in their own ability to be successful in stoma care. SE plays an important role in adapting to the stoma. Not only do individuals who can self-care better adapt to a stoma.
Structured education has an important place in the ability of ostomates to cope with these problems. This training is indispensable, as it helps ostomates cope with physical, psychological, and social difficulties. Face-to-face training given during hospitalization is a traditional and effective method designed to impart new information and self-care behavior. However, it has its limitations. This type of training is time-consuming, and retaining the given information is often difficult for patients, as they experience postoperative anxiety and pain. In addition, the number of ostomy and wound care nurses in Turkey is not sufficient. When ostomates experience a problem with their stoma, they may not be able to contact the ostomy nurse. Considering that stomas are usually applied to cancer patients, their general condition deteriorates due to chemotherapy and radiotherapy. For this reason, it is important that ostomates receive information on living with a stoma in their mobile environment, thus having such information accessible at any time through their smartphones.
The literature contains limited studies comparing the effects of face-to-face/booklet and mobile training on the adaptation, self-efficacy, and peristomal skin complications of ostomates. Accordingly, this study evaluated the effect of the mobile application and booklet training in the education of ostomates on the adaptation and skin complications of ostomates. Thus, the study examined the effect of using innovative, technology-based education approaches in the education of ostomates, offering a significant contribution to the literature and individual-centered care.
- Being tested
- Assigned Interventions STOMA-M
- Keywords
- ostomy adjustment, mobile application, self-efficacy, peristomal skin lesions, nursing
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned Interventions STOMA-MOther
The training, which includes information on stoma care, maintenance of daily life activities, and complication management, was given to the patients in the experimental group via the STOMA-M.
| Study group | Role | What they receive |
|---|---|---|
| Booklet | No intervention | Control-Classical patient education before the operation, the patient is educated with the classical method brochure. |
| STOMA-M | Experimental | Patients are educated with the mobil aplikasyon method. Receives: Other: Assigned Interventions STOMA-M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adjustment Scale for Individuals with Ostomy
It is a self-assessment scale consisting of 23 items developed by to determine the compliance of individuals with stoma. The scale, which is graded in a five-point Likert type, has four sub-dimensions. These four dimensions are anger, social adaptation, anxiety/worry and acceptance. While the lowest score on the scale is '0', the highest score is '92'
Measured: Evaluation of the differences between scales score - The scale is filled in 2 times; After being discharged from the hospital the first months(1) and third months (2)
Secondary outcomes (1)
Stoma Self-Efficacy Scale
The scale consists of 22 items. The scale, which is graded in a five-point Likert type, consists of two sub-dimensions. Sub-dimensions; Stoma Care is Self-Efficacy and Social Self-Efficac. The possible score on the scale ranges from 22 to 110. The higher the score, the better the level of self-efficacy
Measured: Evaluation of the differences between scales score - The scale is filled in 2 times; After being discharged from the hospital the first months(1) and third months (2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start18 Nov 2020
- Primary completion10 Dec 2020
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Quasi-experimental study with a post-test control group.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylem Togluk Yigitoglu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664503
- Sponsor's protocol ID
- IstanbulU 2022-07/12
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yigitoglu ET, Sendir M. Effect of a mobile patient education application on adjustment to stoma and development of peristomal skin lesions: a quasi-experimental study. Wound Manag Prev. 2021 Dec;67(12):30-40.
PubMed 35030542Yigitoglu, E. T., & Sendir, M. (2021a). Mobile Application in Stoma Care Education: Stoma-M. Journal of Education and Research in Nursing, 18 (2), 210-216. DOI: 10.5152/jern.2021.85688
Karacay P, Togluk Yigitoglu E, Karadag A. The validity and reliability of the Stoma Self-Efficacy Scale: A methodological study. Int J Nurs Pract. 2020 Dec;26(6):e12840. doi: 10.1111/ijn.12840. Epub 2020 Apr 17.
PubMed 32301580Karadağ, A., Göçmen, Z. B., Korkut, H., & Çelik, B. (2011). Turkish adaptation of the adjustment scale for individuals with ostomy. National Journal of Surgery, 27(4), 206-211.
Ay A, Bulut H. Assessing the Validity and Reliability of the Peristomal Skin Lesion Assessment Instrument Adapted for Use in Turkey. Ostomy Wound Manage. 2015 Aug;61(8):26-34.
PubMed 26291898Pate K, Powers K, Coffman MJ, Morton S. Improving Self-Efficacy of Patients With a New Ostomy With Written Education Materials: A Quality Improvement Project. J Perianesth Nurs. 2022 Oct;37(5):620-625. doi: 10.1016/j.jopan.2021.11.020. Epub 2022 Mar 5.
PubMed 35260298Wang QQ, Zhao J, Huo XR, Wu L, Yang LF, Li JY, Wang J. Effects of a home care mobile app on the outcomes of discharged patients with a stoma: A randomised controlled trial. J Clin Nurs. 2018 Oct;27(19-20):3592-3602. doi: 10.1111/jocn.14515. Epub 2018 Jul 10.
PubMed 29775491Seo HW. Effects of the frequency of ostomy management reinforcement education on self-care knowledge, self-efficacy, and ability of stoma appliance change among Korean hospitalised ostomates. Int Wound J. 2019 Mar;16 Suppl 1(Suppl 1):21-28. doi: 10.1111/iwj.13047.
PubMed 30793857Wound, Ostomy and Continence Nurses Society; Guideline Development Task Force. WOCN Society Clinical Guideline: Management of the Adult Patient With a Fecal or Urinary Ostomy-An Executive Summary. J Wound Ostomy Continence Nurs. 2018 Jan/Feb;45(1):50-58. doi: 10.1097/WON.0000000000000396.
PubMed 29300288Yaşar, Z., & Üstündağ, H. (2021). Determination of quality of life and self-efficacy levels of patients with stoma. Journal of Celal Bayar University Health Sciences Institute, 8(1), 107-115.
Collado-Boira EJ, Machancoses FH, Folch-Ayora A, Salas-Medina P, Bernat-Adell MD, Bernalte-Marti V, Temprado-Albalat MD. Self-Care and Health-Related Quality of Life in Patients with Drainage Enterostomy: A Multicenter, Cross Sectional Study. Int J Environ Res Public Health. 2021 Mar 2;18(5):2443. doi: 10.3390/ijerph18052443.
PubMed 33801488Heidari-Beni F, Esmaeilian S, Yousefi F, Zarei MR, Farahani MA. Comparison of Face-to-Face Education and Multimedia Software Education on Adjustment of Patients With Intestinal Ostomy: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2022 Mar-Apr 01;49(2):152-157. doi: 10.1097/WON.0000000000000854.
PubMed 35255067Togluk Yigitoglu E, Karacay P, Sendir M. The Effect of Mobile Education on Adjustment to Stoma, Self-efficacy, and Peristomal Skin Lesions: A Quasi-Experimental Study. Florence Nightingale J Nurs. 2025 Nov 4;33:e24254. doi: 10.5152/FNJN.2025.24254.
PubMed 41709606
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Health Education on Adaptation to Stoma, Self-efficacy, and Peristomal Skin Lesions: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT05664503
- Acronym / sponsor ID
- IstanbulU 2022-07/12
- Keywords
- ostomy adjustment, mobile application, self-efficacy, peristomal skin lesions, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 23 Dec 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.
To explore the effect of the Stoma Mobile application-based training method on the psychosocial adjustment, self-efficacy, and development of peristomal skin complications in individuals with a stoma.
Quasi-experimental study with a post-test control group. Patients who met the inclusion criteria were randomly selected. While the experimental group (n=30) received training with the Stoma Mobile application, the control group (n=30) received training with the booklet. Stoma compliance, self-efficacy level, and the presence of complications were compared in both groups in the first and third months after discharge.
H11: Individuals who receive stoma care training via STOMA-M will have a higher adaptation to stomas than individuals who receive stoma care training via a booklet.
H12: The SE levels of individuals who receive stoma care training via STOMA-M will be higher than those who receive stoma care training via a booklet.
H13: Peristomal skin complications of individuals who receive stoma care training via STOMA-M will be lower than those who receive stoma care training via a booklet.
The population of the study included patients who had a stoma for the first time, were in a university hospital in Istanbul between December 2020 and December 2021, and who were 18 years of age and older, literate, without any physical and psychological disabilities, able to use smartphones, and willing to participate in the study. Patients who were in the same room or underwent a urostomy were not included in the study.
The experimental group using the Stoma Health Mobile application had higher psychosocial adjustment and self-efficacy scores than the control group, and the peristomal skin lesion complication rate was lower than that of the control group. Social self-efficacy positively affects stoma compliance, and the Stoma Mobile application positively affects the level of social self-efficacy and adaptation of ostomates to the stoma
Detailed description
Ostomates need to learn to cope with new self-care routines and emotional problems related to changes in body image and self-perception. This learning process is defined as psychosocial adjustment. Adaptation of the patient to the stoma after surgery is part of the process in which the patient re-coordinates the body, self, and external world. In addition to the follow-up process after surgical treatments, psychosocial adjustment is one of the most important factors that define SE and quality of life.
Bandura (1994) defines SE as the belief that people can effectively initiate the necessary activities and reach results in events related to their lives. In other words, SE is a dynamic cognitive process that expresses the confidence of individuals with a stoma in their own ability to be successful in stoma care. SE plays an important role in adapting to the stoma. Not only do individuals who can self-care better adapt to a stoma.
Structured education has an important place in the ability of ostomates to cope with these problems. This training is indispensable, as it helps ostomates cope with physical, psychological, and social difficulties. Face-to-face training given during hospitalization is a traditional and effective method designed to impart new information and self-care behavior. However, it has its limitations. This type of training is time-consuming, and retaining the given information is often difficult for patients, as they experience postoperative anxiety and pain. In addition, the number of ostomy and wound care nurses in Turkey is not sufficient. When ostomates experience a problem with their stoma, they may not be able to contact the ostomy nurse. Considering that stomas are usually applied to cancer patients, their general condition deteriorates due to chemotherapy and radiotherapy. For this reason, it is important that ostomates receive information on living with a stoma in their mobile environment, thus having such information accessible at any time through their smartphones.
The literature contains limited studies comparing the effects of face-to-face/booklet and mobile training on the adaptation, self-efficacy, and peristomal skin complications of ostomates. Accordingly, this study evaluated the effect of the mobile application and booklet training in the education of ostomates on the adaptation and skin complications of ostomates. Thus, the study examined the effect of using innovative, technology-based education approaches in the education of ostomates, offering a significant contribution to the literature and individual-centered care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental study with a post-test control group.
| Arm | Type | Receives |
|---|---|---|
| Booklet | No intervention | –Control-Classical patient education before the operation, the patient is educated with the classical method brochure. |
| STOMA-M | Experimental | Other: Assigned Interventions STOMA-MPatients are educated with the mobil aplikasyon method. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age and older
- Literate,
- Without any physical and psychological disabilities,
- Able to use smartphones
- Willing to participate in the study.
Key exclusion criteria (1 listed)
- Patients who were in the same room or underwent a urostomy were not included in 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 |
|---|---|---|
| Assigned Interventions STOMA-MThe training, which includes information on stoma care, maintenance of daily life activities, and complication management, was given to the patients in the experimental group via the STOMA-M. | Other | STOMA-M |
Primary outcome
Change in Adjustment Scale for Individuals with Ostomy
Time frame: Evaluation of the differences between scales score - The scale is filled in 2 times; After being discharged from the hospital the first months(1) and third months (2)
It is a self-assessment scale consisting of 23 items developed by to determine the compliance of individuals with stoma. The scale, which is graded in a five-point Likert type, has four sub-dimensions. These four dimensions are anger, social adaptation, anxiety/worry and acceptance. While the lowest score on the scale is '0', the highest score is '92'
1 secondary outcome
Stoma Self-Efficacy Scale
Time frame: Evaluation of the differences between scales score - The scale is filled in 2 times; After being discharged from the hospital the first months(1) and third months (2)
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 23 Dec 2022.
- Background: PubMed 35030542Yigitoglu ET, Sendir M. Effect of a mobile patient education application on adjustment to stoma and development of peristomal skin lesions: a quasi-experimental study. Wound Manag Prev. 2021 Dec;67(12):30-40.
- BackgroundYigitoglu, E. T., & Sendir, M. (2021a). Mobile Application in Stoma Care Education: Stoma-M. Journal of Education and Research in Nursing, 18 (2), 210-216. DOI: 10.5152/jern.2021.85688
- Background: PubMed 32301580Karacay P, Togluk Yigitoglu E, Karadag A. The validity and reliability of the Stoma Self-Efficacy Scale: A methodological study. Int J Nurs Pract. 2020 Dec;26(6):e12840. doi: 10.1111/ijn.12840. Epub 2020 Apr 17.
- BackgroundKaradağ, A., Göçmen, Z. B., Korkut, H., & Çelik, B. (2011). Turkish adaptation of the adjustment scale for individuals with ostomy. National Journal of Surgery, 27(4), 206-211.
- Background: PubMed 26291898Ay A, Bulut H. Assessing the Validity and Reliability of the Peristomal Skin Lesion Assessment Instrument Adapted for Use in Turkey. Ostomy Wound Manage. 2015 Aug;61(8):26-34.
- Background: PubMed 35260298Pate K, Powers K, Coffman MJ, Morton S. Improving Self-Efficacy of Patients With a New Ostomy With Written Education Materials: A Quality Improvement Project. J Perianesth Nurs. 2022 Oct;37(5):620-625. doi: 10.1016/j.jopan.2021.11.020. Epub 2022 Mar 5.
- Background: PubMed 29775491Wang QQ, Zhao J, Huo XR, Wu L, Yang LF, Li JY, Wang J. Effects of a home care mobile app on the outcomes of discharged patients with a stoma: A randomised controlled trial. J Clin Nurs. 2018 Oct;27(19-20):3592-3602. doi: 10.1111/jocn.14515. Epub 2018 Jul 10.
- Background: PubMed 30793857Seo HW. Effects of the frequency of ostomy management reinforcement education on self-care knowledge, self-efficacy, and ability of stoma appliance change among Korean hospitalised ostomates. Int Wound J. 2019 Mar;16 Suppl 1(Suppl 1):21-28. doi: 10.1111/iwj.13047.
- Background: PubMed 29300288Wound, Ostomy and Continence Nurses Society; Guideline Development Task Force. WOCN Society Clinical Guideline: Management of the Adult Patient With a Fecal or Urinary Ostomy-An Executive Summary. J Wound Ostomy Continence Nurs. 2018 Jan/Feb;45(1):50-58. doi: 10.1097/WON.0000000000000396.
- BackgroundYaşar, Z., & Üstündağ, H. (2021). Determination of quality of life and self-efficacy levels of patients with stoma. Journal of Celal Bayar University Health Sciences Institute, 8(1), 107-115.
- Background: PubMed 33801488Collado-Boira EJ, Machancoses FH, Folch-Ayora A, Salas-Medina P, Bernat-Adell MD, Bernalte-Marti V, Temprado-Albalat MD. Self-Care and Health-Related Quality of Life in Patients with Drainage Enterostomy: A Multicenter, Cross Sectional Study. Int J Environ Res Public Health. 2021 Mar 2;18(5):2443. doi: 10.3390/ijerph18052443.
- Background: PubMed 35255067Heidari-Beni F, Esmaeilian S, Yousefi F, Zarei MR, Farahani MA. Comparison of Face-to-Face Education and Multimedia Software Education on Adjustment of Patients With Intestinal Ostomy: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2022 Mar-Apr 01;49(2):152-157. doi: 10.1097/WON.0000000000000854.
- Individual participant dataSharing planned: No
Related trials for Nurse's Role
Not yet recruiting
The Effect of Creative Drama on the Therapeutic Communication Skills and Empathy Levels of Pediatric Nursing Students: A Randomized Controlled Study
Nurse's Role, Empathy
Active, not recruiting
Advancing Nursing Practices in Hospital Oncology Care
Gastrointestinal Cancer, Gastrointestinal Disease
RecruitingPhase 1
Two Different Therapeutic Interventions Applied During Blood Sampling in Children
Blood Sampling, Child, Only
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Not yet recruitingObservational study
Research-patientS and Clinical researcH Nurses: Exploring Their Experiences of tAking paRt in Clinical resEarch in the NHS
Experiences, Lived Experiences
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 Assigned Interventions STOMA-M in people with Nurse's Role and Patient Compliance, run by Istanbul 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 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: finished, as of the sponsor's last update on 23 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?
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?
Change in Adjustment Scale for Individuals with Ostomy (time frame: Evaluation of the differences between scales score - The scale is filled in 2 times; After being discharged from the hospital the first months(1) and third months (2)). 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 NCT05664503, which also lists 13 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 23 Dec 2022.