Patient PortalsNCT04077541
the Effects of a Nursing Trauma Care Bundle
A study testing internet platform in people with Patient Portals, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
To examine the effects of evidence-based care bundles combined with the internet platform in patients with extremity injuries. A longitudinal and two group experimental design will be used. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patient Portals
- What is being tested?
- internet platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Oct 2019to 25 Jan 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ISS (Injury Severe Score)>9
- Agree to participate in this examination for 6 months after discharge
- Accidental extremity injuries
- Have a smart phone and access to the Internet
Who cannot join
- Discharged within 24 hours
- Cognitive dysfunction and unable to provide formal consent
- Severe brain damage
- Burned patient
- Severe psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Nursing Trauma Care Bundle Combined With the Internet Platform in Patients With Extremity Injuries
To examine the effects of evidence-based care bundles combined with the internet platform in patients with extremity injuries. A longitudinal and two group experimental design will be used. Outcome measures for the trauma care bundles will use the Barthel's Index, the Posttraumatic Diagnostic Scale, and the World Health Organization Quality of Life questionnaire. The results may influence health policy and clinical practice, and a wide range of injured patient outcomes.
Read the detailed description
Background: Over 50% of injuries are accompanied by musculoskeletal injuries that are life-threatening, require amputation or lead to major extremity dysfunctions. Some barriers exist to deliver evidence-based care in the trauma group. Based on recent research findings, this project will be an evidence-based project and evaluation of care bundles combined with e health care to establish and refine evidence-based care guidelines for patients with extremity injuries in Taiwan.
Aims: To examine the effects of evidence-based care bundles combined with the internet platform in patients with extremity injuries.
Methods: A longitudinal and two group experimental design will be used. The trauma care bundles combined with internet platform will be implemented over 24-hour admission and ended in 10-14 days after hospital discharge. Participants will be patients with extremity injuries that meet the criteria. The experimental group and the control group will be given the same routine care except for the trauma care bundles. Both groups will be followed up at 3 and 6 months after hospital discharge. Fifty-eight participants for each group will be expected. The generalized estimating equations will be used to analyze the data. Outcome measures for the trauma care bundles will use the Barthel's Index, the Posttraumatic Diagnostic Scale, and the World Health Organization Quality of Life questionnaire.
Expected outcomes: This is an innovation project as it combines a comprehensive trauma care bundles with internet platform, and applied in the biggest injury population in Taiwan. It may be the pioneer study to integrate care bundle and e-health care in trauma care. The results may influence health policy and clinical practice, and a wide range of injured patient outcomes. The internet platform established by the research team may be an important template for domestic e-health in hospital-based settings and long-term care facilities.
- Conditions
- Patient Portals
- Being tested
- internet platform
- Keywords
- trauma care bundles, internet platform, patients with extremity injuries, experimental design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet platformBehavioural
The trauma care bundles combined with the internet platform.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | The trauma care bundles combined with the internet platform. Receives: Behavioral: internet platform |
| The control group | No intervention | Only trauma care bundles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Numeric Pain Rating Scale
The NPRS is a one-dimensional measure of pain intensity in adults. A NPRS has similar anchors at the extremes but offers numbers from 0 through 10. It is well known and broadly used scale in clinical settings. It also used to be applied in post injury pain
Measured: at 1 day before hospital discharge
the Numeric Pain Rating Scale
The NPRS is a one-dimensional measure of pain intensity in adults. A NPRS has similar anchors at the extremes but offers numbers from 0 through 10. It is well known and broadly used scale in clinical settings. It also used to be applied in post injury pain
Measured: at 10 to 14 days after hospital discharge
the Barthel's Index
The BI will be used to measure functional disabilities patients with extremity injury. The BI, organically developed by Mahoney and Barthel (1965), assesses BADL in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. A total BI score of 0 to 20 correlates with total dependence, 21 to 60 correlates with severe dependence, 61 to 90 correlates with moderate dependence, 91 to 99 correlates with slight dependence, and 100 correlates with total independence. The Chinese version was applied in older populations, with Cronbach's alpha ranging from 0.79 to .085 (Shyu, Tang, Tsai, Liang, \& Chen, 2006). The Cronbach's alpha for this current project will be retested using the injury group.
Measured: at 1 day before hospital discharge
the Barthel's Index
The BI will be used to measure functional disabilities patients with extremity injury. The BI, organically developed by Mahoney and Barthel (1965), assesses BADL in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. A total BI score of 0 to 20 correlates with total dependence, 21 to 60 correlates with severe dependence, 61 to 90 correlates with moderate dependence, 91 to 99 correlates with slight dependence, and 100 correlates with total independence. The Chinese version was applied in older populations, with Cronbach's alpha ranging from 0.79 to .085 (Shyu, Tang, Tsai, Liang, \& Chen, 2006). The Cronbach's alpha for this current project will be retested using the injury group.
Measured: at 10 to 14 days after hospital discharge
the Barthel's Index
The BI will be used to measure functional disabilities patients with extremity injury. The BI, organically developed by Mahoney and Barthel (1965), assesses BADL in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. A total BI score of 0 to 20 correlates with total dependence, 21 to 60 correlates with severe dependence, 61 to 90 correlates with moderate dependence, 91 to 99 correlates with slight dependence, and 100 correlates with total independence. The Chinese version was applied in older populations, with Cronbach's alpha ranging from 0.79 to .085 (Shyu, Tang, Tsai, Liang, \& Chen, 2006). The Cronbach's alpha for this current project will be retested using the injury group.
Measured: at 3 months after hospital discharge
the Barthel's Index
The BI will be used to measure functional disabilities patients with extremity injury. The BI, organically developed by Mahoney and Barthel (1965), assesses BADL in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. A total BI score of 0 to 20 correlates with total dependence, 21 to 60 correlates with severe dependence, 61 to 90 correlates with moderate dependence, 91 to 99 correlates with slight dependence, and 100 correlates with total independence. The Chinese version was applied in older populations, with Cronbach's alpha ranging from 0.79 to .085 (Shyu, Tang, Tsai, Liang, \& Chen, 2006). The Cronbach's alpha for this current project will be retested using the injury group.
Measured: at 6 months after hospital discharge
the Posttraumatic Diagnostic Scale
The PTDS is a self-report instrument for post traumatic syndrome that is simple to administer and has demonstrated good psychometric properties. The PTSD will not use to diagnose if injured patients have psychological illnesses. It will be applied in measuring how and what post traumatic symptoms that patients will have after injuries. The scale is a structured interview for assessing PTSD diagnostic status and symptom. The degree of severity is rated on a five-point scale scoring with zero: not at all, one: once per week or less / a little, two: 2 to 3 times per week / somewhat, three: 4 to 5 times per week / a lot, and four: 6 or more times a week / severe (Pynoos et al., 1993). This instrument was not only broadly used in patients with mental illnesses, but also used in patients with vehicle accidents domestically (Wang, 2013). The Cronbach's alpha for the current study will be retested using the injury group.
Measured: at 3 months after hospital discharge
the Posttraumatic Diagnostic Scale
The PTDS is a self-report instrument for post traumatic syndrome that is simple to administer and has demonstrated good psychometric properties. The PTSD will not use to diagnose if injured patients have psychological illnesses. It will be applied in measuring how and what post traumatic symptoms that patients will have after injuries. The scale is a structured interview for assessing PTSD diagnostic status and symptom. The degree of severity is rated on a five-point scale scoring with zero: not at all, one: once per week or less / a little, two: 2 to 3 times per week / somewhat, three: 4 to 5 times per week / a lot, and four: 6 or more times a week / severe (Pynoos et al., 1993). This instrument was not only broadly used in patients with mental illnesses, but also used in patients with vehicle accidents domestically (Wang, 2013). The Cronbach's alpha for the current study will be retested using the injury group.
Measured: at 6 months after hospital discharge
the WHOQOL-BREF
The World Health Organization Quality of Life questionnaire (WHOQOL-BREF) will be used to measure HRQOL. Six popular generic instruments of HRQOL are commonly used as disability outcome measures, some of them were developed later were tested trans-culturally in extensive research programs such as the WHOQOL-BREF (Yao, 2000). The WHOQOL-BREF is a 28-tem scale that is measure along with 4 domains including physical, psychological, social relationship and environment. Scores range from 1 to 5 with higher scores indicating higher quality of life (The WHOQOL Taiwan Group, 2000). The reliability and validity of the Chinese WHOQOL-BREF have been tested in various clinical settings.
Measured: at 3 months after hospital discharge
the WHOQOL-BREF
The World Health Organization Quality of Life questionnaire (WHOQOL-BREF) will be used to measure HRQOL. Six popular generic instruments of HRQOL are commonly used as disability outcome measures, some of them were developed later were tested trans-culturally in extensive research programs such as the WHOQOL-BREF (Yao, 2000). The WHOQOL-BREF is a 28-tem scale that is measure along with 4 domains including physical, psychological, social relationship and environment. Scores range from 1 to 5 with higher scores indicating higher quality of life (The WHOQOL Taiwan Group, 2000). The reliability and validity of the Chinese WHOQOL-BREF have been tested in various clinical settings.
Measured: at 6 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start15 Oct 2019
- Primary completion18 Jun 2021
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient PortalsStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bih-O Lee, PHD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077541
- Sponsor's protocol ID
- KMUHIRB-E(I)-20190203
- Status last verified
- Mar 2022
- First submitted
- 26 Aug 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Nursing Trauma Care Bundle Combined With the Internet Platform in Patients With Extremity Injuries
- ClinicalTrials.gov ID
- NCT04077541
- Acronym / sponsor ID
- KMUHIRB-E(I)-20190203
- Conditions
- Patient Portals
- Keywords
- trauma care bundles, internet platform, patients with extremity injuries, experimental design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 4 Sep 2019 (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 examine the effects of evidence-based care bundles combined with the internet platform in patients with extremity injuries. A longitudinal and two group experimental design will be used. Outcome measures for the trauma care bundles will use the Barthel's Index, the Posttraumatic Diagnostic Scale, and the World Health Organization Quality of Life questionnaire. The results may influence health policy and clinical practice, and a wide range of injured patient outcomes.
Detailed description
Background: Over 50% of injuries are accompanied by musculoskeletal injuries that are life-threatening, require amputation or lead to major extremity dysfunctions. Some barriers exist to deliver evidence-based care in the trauma group. Based on recent research findings, this project will be an evidence-based project and evaluation of care bundles combined with e health care to establish and refine evidence-based care guidelines for patients with extremity injuries in Taiwan.
Aims: To examine the effects of evidence-based care bundles combined with the internet platform in patients with extremity injuries.
Methods: A longitudinal and two group experimental design will be used. The trauma care bundles combined with internet platform will be implemented over 24-hour admission and ended in 10-14 days after hospital discharge. Participants will be patients with extremity injuries that meet the criteria. The experimental group and the control group will be given the same routine care except for the trauma care bundles. Both groups will be followed up at 3 and 6 months after hospital discharge. Fifty-eight participants for each group will be expected. The generalized estimating equations will be used to analyze the data. Outcome measures for the trauma care bundles will use the Barthel's Index, the Posttraumatic Diagnostic Scale, and the World Health Organization Quality of Life questionnaire.
Expected outcomes: This is an innovation project as it combines a comprehensive trauma care bundles with internet platform, and applied in the biggest injury population in Taiwan. It may be the pioneer study to integrate care bundle and e-health care in trauma care. The results may influence health policy and clinical practice, and a wide range of injured patient outcomes. The internet platform established by the research team may be an important template for domestic e-health in hospital-based settings and long-term care facilities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Behavioral: internet platformThe trauma care bundles combined with the internet platform. |
| The control group | No intervention | –Only trauma care bundles. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ISS (Injury Severe Score)>9
- Agree to participate in this examination for 6 months after discharge
- Accidental extremity injuries
- Have a smart phone and access to the Internet
Key exclusion criteria (5 listed)
- Discharged within 24 hours
- Cognitive dysfunction and unable to provide formal consent
- Severe brain damage
- Burned patient
- Severe psychosis
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 |
|---|---|---|
| internet platformThe trauma care bundles combined with the internet platform. | Behavioural | The experimental group |
Primary outcome
the Numeric Pain Rating Scale
Time frame: at 1 day before hospital discharge
The NPRS is a one-dimensional measure of pain intensity in adults. A NPRS has similar anchors at the extremes but offers numbers from 0 through 10. It is well known and broadly used scale in clinical settings. It also used to be applied in post injury pain
the Numeric Pain Rating Scale
Time frame: at 10 to 14 days after hospital discharge
The NPRS is a one-dimensional measure of pain intensity in adults. A NPRS has similar anchors at the extremes but offers numbers from 0 through 10. It is well known and broadly used scale in clinical settings. It also used to be applied in post injury pain
the Barthel's Index
Time frame: at 1 day before hospital discharge
The BI will be used to measure functional disabilities patients with extremity injury. The BI, organically developed by Mahoney and Barthel (1965), assesses BADL in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. A total BI score of 0 to 20 correlates with total dependence, 21 to 60 correlates with severe dependence, 61 to 90 correlates with moderate dependence, 91 to 99 correlates with slight dependence, and 100 correlates with total independence. The Chinese version was applied in older populations, with Cronbach's alpha ranging from 0.79 to .085 (Shyu, Tang, Tsai, Liang, \& Chen, 2006). The Cronbach's alpha for this current project will be retested using the injury group.
the Barthel's Index
Time frame: at 10 to 14 days after hospital discharge
The BI will be used to measure functional disabilities patients with extremity injury. The BI, organically developed by Mahoney and Barthel (1965), assesses BADL in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. A total BI score of 0 to 20 correlates with total dependence, 21 to 60 correlates with severe dependence, 61 to 90 correlates with moderate dependence, 91 to 99 correlates with slight dependence, and 100 correlates with total independence. The Chinese version was applied in older populations, with Cronbach's alpha ranging from 0.79 to .085 (Shyu, Tang, Tsai, Liang, \& Chen, 2006). The Cronbach's alpha for this current project will be retested using the injury group.
the Barthel's Index
Time frame: at 3 months after hospital discharge
The BI will be used to measure functional disabilities patients with extremity injury. The BI, organically developed by Mahoney and Barthel (1965), assesses BADL in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. A total BI score of 0 to 20 correlates with total dependence, 21 to 60 correlates with severe dependence, 61 to 90 correlates with moderate dependence, 91 to 99 correlates with slight dependence, and 100 correlates with total independence. The Chinese version was applied in older populations, with Cronbach's alpha ranging from 0.79 to .085 (Shyu, Tang, Tsai, Liang, \& Chen, 2006). The Cronbach's alpha for this current project will be retested using the injury group.
the Barthel's Index
Time frame: at 6 months after hospital discharge
The BI will be used to measure functional disabilities patients with extremity injury. The BI, organically developed by Mahoney and Barthel (1965), assesses BADL in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. A total BI score of 0 to 20 correlates with total dependence, 21 to 60 correlates with severe dependence, 61 to 90 correlates with moderate dependence, 91 to 99 correlates with slight dependence, and 100 correlates with total independence. The Chinese version was applied in older populations, with Cronbach's alpha ranging from 0.79 to .085 (Shyu, Tang, Tsai, Liang, \& Chen, 2006). The Cronbach's alpha for this current project will be retested using the injury group.
the Posttraumatic Diagnostic Scale
Time frame: at 3 months after hospital discharge
The PTDS is a self-report instrument for post traumatic syndrome that is simple to administer and has demonstrated good psychometric properties. The PTSD will not use to diagnose if injured patients have psychological illnesses. It will be applied in measuring how and what post traumatic symptoms that patients will have after injuries. The scale is a structured interview for assessing PTSD diagnostic status and symptom. The degree of severity is rated on a five-point scale scoring with zero: not at all, one: once per week or less / a little, two: 2 to 3 times per week / somewhat, three: 4 to 5 times per week / a lot, and four: 6 or more times a week / severe (Pynoos et al., 1993). This instrument was not only broadly used in patients with mental illnesses, but also used in patients with vehicle accidents domestically (Wang, 2013). The Cronbach's alpha for the current study will be retested using the injury group.
the Posttraumatic Diagnostic Scale
Time frame: at 6 months after hospital discharge
The PTDS is a self-report instrument for post traumatic syndrome that is simple to administer and has demonstrated good psychometric properties. The PTSD will not use to diagnose if injured patients have psychological illnesses. It will be applied in measuring how and what post traumatic symptoms that patients will have after injuries. The scale is a structured interview for assessing PTSD diagnostic status and symptom. The degree of severity is rated on a five-point scale scoring with zero: not at all, one: once per week or less / a little, two: 2 to 3 times per week / somewhat, three: 4 to 5 times per week / a lot, and four: 6 or more times a week / severe (Pynoos et al., 1993). This instrument was not only broadly used in patients with mental illnesses, but also used in patients with vehicle accidents domestically (Wang, 2013). The Cronbach's alpha for the current study will be retested using the injury group.
the WHOQOL-BREF
Time frame: at 3 months after hospital discharge
The World Health Organization Quality of Life questionnaire (WHOQOL-BREF) will be used to measure HRQOL. Six popular generic instruments of HRQOL are commonly used as disability outcome measures, some of them were developed later were tested trans-culturally in extensive research programs such as the WHOQOL-BREF (Yao, 2000). The WHOQOL-BREF is a 28-tem scale that is measure along with 4 domains including physical, psychological, social relationship and environment. Scores range from 1 to 5 with higher scores indicating higher quality of life (The WHOQOL Taiwan Group, 2000). The reliability and validity of the Chinese WHOQOL-BREF have been tested in various clinical settings.
the WHOQOL-BREF
Time frame: at 6 months after hospital discharge
The World Health Organization Quality of Life questionnaire (WHOQOL-BREF) will be used to measure HRQOL. Six popular generic instruments of HRQOL are commonly used as disability outcome measures, some of them were developed later were tested trans-culturally in extensive research programs such as the WHOQOL-BREF (Yao, 2000). The WHOQOL-BREF is a 28-tem scale that is measure along with 4 domains including physical, psychological, social relationship and environment. Scores range from 1 to 5 with higher scores indicating higher quality of life (The WHOQOL Taiwan Group, 2000). The reliability and validity of the Chinese WHOQOL-BREF have been tested in various clinical settings.
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 31 Mar 2022.
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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.
Bih-O Lee, PHD principal investigator
Kaohsiung Medical 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 internet platform in people with Patient Portals, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 4 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: finished, as of the sponsor's last update on 31 Mar 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 Taiwan. 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?
the Numeric Pain Rating Scale (time frame: at 1 day before hospital discharge). The study lists 10 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 31 Mar 2022.