History
# Registration date Revision Id
2 2023-10-08, 1402/07/16 291411
1 2023-05-03, 1402/02/13 263507
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  • Protocol summary

    Patients treated with extracorporeal lithotripsy referred to Shahid Beheshti Hospital in Hamadan were randomly divided into intervention and control groups. The patients in the intervention group lie on the opposite side of the side that has pain, and the exact location of the Qiu point is determined, and force is applied to the spine with the thumb for 5 minutes in the direction of 45 degrees. The strength of the thumb increases gradually and with a regular rhythm until the patient feels warmth in the area.
    Patients treated with extracorporeal lithotripsy referred to Shahid Beheshti Hospital in Hamadan were randomly divided into intervention and control groups. The patients in the intervention group lie on the opposite side of the side that has pain, and the exact location of the Qiu point is determined, and force is applied to the spine with the thumb for 3 minutes in the direction of 45 degrees. The strength of the thumb increases gradually and with a regular rhythm until the patient feels warmth in the area.
    بیماران تحت درمان با سنگ شکنی برون اندامی مراجعه کننده به بیمارستان شهید بهشتی همدان به طور تصادفی به دو گروه مداخله و کنترل تقسیم می شوند. بیماران در گروه مداخله، به پهلوی مخالف سمتی که دارای درد است دراز میکشند و محل دقیق نقطه Qiu شناسایی و با نیرویی در جهت ◦45 مایل به ستون فقرات با انگشت شست به مدت 5 دقیقه فشار داده می شود. قدرت انگشت شست به تدریج و با ریتمی منظم تا زمانی که بیمار در ناحیه احساس گرمی نماید افزایش می یابد.
    بیماران تحت درمان با سنگ شکنی برون اندامی مراجعه کننده به بیمارستان شهید بهشتی همدان به طور تصادفی به دو گروه مداخله و کنترل تقسیم می شوند. بیماران در گروه مداخله، به پهلوی مخالف سمتی که دارای درد است دراز میکشند و محل دقیق نقطه Qiu شناسایی و با نیرویی در جهت ◦45 مایل به ستون فقرات با انگشت شست به مدت 3 دقیقه فشار داده می شود. قدرت انگشت شست به تدریج و با ریتمی منظم تا زمانی که بیمار در ناحیه احساس گرمی نماید افزایش می یابد.
    Study groups: Intervention group: In the intervention group, the massage intervention is performed at the Qiu acupuncture point located around the lumbocostal region for 5 minutes. The main outcome variables include the severity of nausea, pain and physiological indicators (including heart rate and blood pressure) of the patients are recorded. Control group: In the control group, massage intervention is performed in the neutral area and around the main point. Patients in both groups receive routine care.
    Study groups: Intervention group: In the intervention group, the massage intervention is performed at the Qiu acupuncture point located around the lumbocostal region for 3 minutes. The main outcome variables include the severity of nausea, pain and physiological indicators (including heart rate and blood pressure) of the patients are recorded. Control group: In the control group, massage intervention is performed in the neutral area and around the main point. Patients in both groups receive routine care.
    گروه مداخله: مداخله ماساژ در گروه مداخله در نقطه طب سوزنی Qiu واقع در اطراف ناحیه لومبوکوستال به مدت 5 دقیقه انجام می شود. متغیرهای پیامد اصلی شامل شدت تهوع، درد و شاخص های فیزیولوژیک(شامل ضربان قلب و فشار خون) بیماران ثبت می گردد. گروه کنترل: در گروه کنترل مداخله طب فشاری در ناحیه خنثی و در اطراف نقطه اصلی انجام می شود. بیماران در هر دو گروه مراقبت های روتین را دریافت می کنند.
    گروه مداخله: مداخله ماساژ در گروه مداخله در نقطه طب سوزنی Qiu واقع در اطراف ناحیه لومبوکوستال به مدت 3 دقیقه انجام می شود. متغیرهای پیامد اصلی شامل شدت تهوع، درد و شاخص های فیزیولوژیک(شامل ضربان قلب و فشار خون) بیماران ثبت می گردد. گروه کنترل: در گروه کنترل مداخله طب فشاری در ناحیه خنثی و در اطراف نقطه اصلی انجام می شود. بیماران در هر دو گروه مراقبت های روتین را دریافت می کنند.
  • General information

    empty
    Update based on pilot study results
    empty
    به روز رسانی بر اساس نتایج مطالعه مقدماتی
    Randomization method: Block randomization method with unequal blocks (for example 2, 4, 6, etc.) will be used - Randomization unit: individual - How to build a random sequence: An equal number of each group will be placed in each block. In this way, first the list of all permutations related to the size of the desired block is determined and then will be randomly selected as many as the number of sample from permutation. The method used to generate the random allocation sequence is from the online randomization service Sealed Envelope Ltd. 2019 will be used (https://www.sealedenvelope.com/simple-randomiser/v1/lists). The method of concealing the allocation is to use sealed envelopes.
    Randomization method: Block randomization method with unequal blocks. will be used - Randomization unit: individual - How to build a random sequence: An equal number of each group will be placed in each block. In this way, first, the list of all permutations related to the size of the desired block is determined and then will be randomly as many as the number of samples from the permutation. The method used to generate the random allocation sequence is using a computer. The method of concealing the allocation is to use sealed envelopes.
    روش تصادفی سازی: روش تصادفی سازی بلوکی با بلوک های نابرابر(مثلا 2، 4، 6 و ...) استفاده خواهد شد - واحد تصادفی سازی: فردی - نحوه ی ساخت توالی تصادفی: در هر بلوک تعداد مساوی از هر گروه قرار خواهد گرفت به اینصورت که ابتدا لیست تمام جایگشت های مربوط به اندازه های بلوک مورد نظر تعیین می شود و سپس به صورت تصادفی به اندازه تعداد نمونه از جایگشت ها انتخاب خواهد شد. روش مورد استفاده برای تولید توالی تخصیص تصادفی: از سرویس تصادفی‌سازی آنلاین Sealed Envelope Ltd. 2019 استفاده خواهد شد(https://www.sealedenvelope.com/simple-randomiser/v1/lists). روش پنهان سازی تخصیص، استفاده از پاکت‌نامه‌های غیرشفاف مهر و موم‌شده می باشد.
    روش تصادفی سازی: روش تصادفی سازی بلوکی استفاده خواهد شد - واحد تصادفی سازی: فردی - نحوه ی ساخت توالی تصادفی: در هر بلوک تعداد مساوی از هر گروه قرار خواهد گرفت به اینصورت که ابتدا لیست تمام جایگشت های مربوط به اندازه های بلوک مورد نظر تعیین می شود و سپس به صورت تصادفی به اندازه تعداد نمونه از جایگشت ها انتخاب خواهد شد. روش مورد استفاده برای تولید توالی تخصیص تصادفی: با استفاده از کامپیوتر. روش پنهان سازی تخصیص، استفاده از پاکت‌نامه‌های غیرشفاف مهر و موم‌شده می باشد.
    The blind groups in this study include patients, an assistant research collector, and a statistician; in such a way that none of the patients and also the data collector were aware of the allocation of patients to the two intervention and control groups and also the data obtained from this study without informing the statistical expert about the allocation of data to each intervention and control groups, will be analyzed.
    The blind groups in this study include patients and an assistant research collector; in such a way that none of the patients and the data collector will be aware of the allocation of patients to the two intervention and control groups.
    گروه های کورشده در این مطالعه شامل بیماران، کمک پژوهشگر جمع آوری کننده اطلاعات و کارشناس آمار است؛ به نحوی که هیچ کدام از بیماران و همچنین فرد جمع آوری کننده اطلاعات از تخصیص بیماران به دو گروه مداخله و کنترل آگاهی نداشته و همچنین داده های حاصل از این مطالعه بدون اطلاع کارشناس آمار از تخصیص داده ها به هر یک از گروه های مداخله و کنترل، مورد تجزیه و تحلیل قرار می گیرد.
    گروه های کورشده در این مطالعه شامل بیماران و کمک پژوهشگر جمع آوری کننده اطلاعات است؛ به نحوی که هیچ کدام از بیماران و همچنین فرد جمع آوری کننده اطلاعات از تخصیص بیماران به دو گروه مداخله و کنترل آگاهی نخواهند داشت.
  • Primary outcomes

    #1
    The intensity of pain will be evaluated before and after extracorporeal shock wave lithotripsy
    Before intervention, 1, 10, 20, 30, 40 and 50 minutes after the intervention
    شدت درد قبل و بعد از سنگ شکنی برون اندامی با موج ضربه ای ارزیابی می شود.
    قبل از مداخله، 1، 10، 20، 30، 40 و 50 دقیقه بعد از مداخله
    Numeric pain rating scale (NRS)
    Numeric pain rating scale
    #2
    Before intervention, 1, 5, 15, 20, 30 and 60 minutes after the intervention
    Before intervention, 1, 10, 20, 30, 40 and 50 minutes after the intervention
    قبل از مداخله، 1، 5، 15، 30 و 60 دقیقه بعد از مداخله
    قبل از مداخله، 1، 10، 20، 30، 40 و 50 دقیقه بعد از مداخله
    #3
    Before intervention, 1, 5, 15, 20, 30 and 60 minutes after the intervention
    Before intervention, 1, 10, 20, 30, 40 and 50 minutes after the intervention
    قبل از مداخله، 1، 5، 15، 30 و 60 دقیقه بعد از مداخله
    قبل از مداخله، 1، 10، 20، 30، 40 و 50 دقیقه بعد از مداخله
  • Intervention groups

    #1
    Intervention group: Patients in the intervention group will receive the intervention before the extra-organ stone crushing in the same place in a room with minimal environmental stimuli (such as sound, temperature, light, etc.) while respecting privacy. For this purpose, the researcher first takes out his watch and ring and washes and warms his hands, then stretches the paravans around the patient's bed and the patient lies on the opposite side that is in pain so that the painful side of the patient faces the side. be placed above The patient's knees are slightly bent into the abdomen. Acupressure intervention in the present study is performed at the acupuncture point of Qiu. This point was identified by Unicav Q, a urologist, during several decades of activity in connection with the management of acute renal colic pains. In order to find this point, move down and inside the lumboxtal point by the width of a thumb, and the desired point is selected. After observing the location and choosing the exact location and marking it with his thumb, the researcher presses a force in the direction of 45 degrees to the spine for 5 minutes. Thumb strength will be done gradually and with a regular rhythm until the patient feels warmth in the area. The results examined in this study are measured before the intervention, immediately after 5, 30 and 60 minutes after the massage.
    Intervention group: Patients in the intervention group will receive the intervention before the extra-organ stone crushing in the same place in a room with minimal environmental stimuli (such as sound, temperature, light, etc.) while respecting privacy. For this purpose, the researcher first takes out his watch and ring and washes and warms his hands, then stretches the paravanes around the patient's bed and the patient lies on the opposite side that is in pain so that the painful side of the patient faces the side. be placed above the patient's knees are slightly bent into the abdomen. Acupressure intervention in the present study is performed at the acupuncture point of Qiu. This point was first identified by Yunqiao Qiu, a urology specialist at a hospital affiliated with Guangzhou Medical University in China, for treating acute kidney colic pain. This anatomical point is located about the width of one finger (the size of the body is equivalent to 1.3 inches) below and one thumb's width inside the intersection of the twelfth rib and the column of vertebrae (Lumbo-costal point). After observing the location choosing the exact location and marking it with his thumb, the researcher presses a force in the direction of 45 degrees to the spine for 3 minutes. Thumb strength will be done gradually and with a regular rhythm until the patient feels warmth in the area. The massage intervention will be repeated once exactly before the commencement of lithotripsy. The results examined in this study are measured before massage and at 1, 10, 20, 30, 40, and 50 minutes.
    گروه مداخله: بیماران در گروه مداخله قبل از سنگ شکنی برون اندامی در همان محل در اتاقی با حداقل محرکات محیطی(از جمله صدا، دما، نور و...) و ضمن رعایت حریم خصوصی مداخله را دریافت خواهند کرد. بدین منظور ابتدا پژوهشگر ساعت و انگشتر دست خود را خارج کرده و دست های خود را شسته و گرم می کند، سپس در اطراف تخت بیمار پاراوان کشیده و بیمار به پهلوی مخالف سمتی که دارای درد است دراز میکشد به طوری که سمت دردناک در سطح بالا قرار گیرد، زانوهای بیمار اندکی به داخل شکم خم می شود. مداخله طب فشاری در مطالعه حاضر در نقطه طب سوزنی Qiu انجام می شود. این نقطه توسط یونکیاو کیو پزشک متخصص اورولوژی در طی چندین دهه فعالیت در ارتباط با مدیریت درد های کولیکی حاد کلیه شناسایی جهت پیدا کردن این نقطه به اندازه یک عرض انگشت شست به سمت پایین و داخل نقطه لومبوکوستال حرکت کرده و نقطه مورد نظر انتخاب می شود. پژوهشگر بعد از رویت محل و انتخاب محل دقیق و علامت گذاری آن نیرویی در جهت ◦45 مایل به ستون فقرات با انگشت شست به مدت 5 دقیقه فشار می دهد. قدرت انگشت شست به تدریج و با ریتمی منظم تا زمانی که بیمار در ناحیه احساس گرمی نماید انجام خواهد شد. پیامدهای مورد بررسی در این مطالعه در مقاطع زمانی پیش از شروع مداخله، بلافاصله بعد، 5، 30 و 60 دقیقه بعد از ماساژ مورد سنجش قرار می گیرد.
    گروه مداخله: بیماران در گروه مداخله قبل از سنگ شکنی برون اندامی در همان محل در اتاقی با حداقل محرکات محیطی(از جمله صدا، دما، نور و...) و ضمن رعایت حریم خصوصی مداخله را دریافت خواهند کرد. بدین منظور ابتدا پژوهشگر ساعت و انگشتر دست خود را خارج کرده و دست های خود را شسته و گرم می کند، سپس در اطراف تخت بیمار پاراوان کشیده و بیمار به پهلوی مخالف سمتی که دارای درد است دراز میکشد به طوری که سمت دردناک در سطح بالا قرار گیرد، زانوهای بیمار اندکی به داخل شکم خم می شود. مداخله طب فشاری در مطالعه حاضر در نقطه طب سوزنی Qiu انجام می شود. این نقطه برای اولین بار توسط Yunqiao Qiu، متخصص اورولوژی در بیمارستان وابسته به دانشگاه پزشکی گوانگژو در چین برای درمان درد حاد کولیک کلیه شناسایی شد. این نقطه اناتومیکی به اندازه عرض یک انگشت (اندازه بدن معادل 1.3 اینچ) در زیر و به عرض یک انگشت شست در داخل محل تلاقی دنده دوازدهم و ستون مهره ها (نقطه لومبو-کستال) قرار دارد. پژوهشگر بعد از رویت محل و انتخاب محل دقیق و علامت گذاری آن نیرویی در جهت ◦45 مایل به ستون فقرات با انگشت شست به مدت 3 دقیقه فشار می دهد. قدرت انگشت شست به تدریج و با ریتمی منظم تا زمانی که بیمار در ناحیه احساس گرمی نماید انجام خواهد شد. همچنین مداخله ماساژ یکبار قبل از سنگ شکنی تکرار خواهد شد. پیامدهای مورد بررسی در این مطالعه در مقاطع زمانی پیش از شروع مداخله، 1، 10، 20، 30، 40 و 50 دقیقه بعد از ماساژ مورد سنجش قرار می گیرد.

Protocol summary

Study aim
The effect of acupressure in point Qiu on the intensity of nausea, pain and physiological parameters of patients treated with extracorporeal lithotripsy is investigated.
Design
Clinical trial with control group, with parallel groups, Double blind, randomized from available samples, phase 3 on 70 patients. A block method was used for randomization.
Settings and conduct
Patients treated with extracorporeal lithotripsy referred to Shahid Beheshti Hospital in Hamadan were randomly divided into intervention and control groups. The patients in the intervention group lie on the opposite side of the side that has pain, and the exact location of the Qiu point is determined, and force is applied to the spine with the thumb for 3 minutes in the direction of 45 degrees. The strength of the thumb increases gradually and with a regular rhythm until the patient feels warmth in the area.
Participants/Inclusion and exclusion criteria
Entry conditions: 1) extracorporeal lithotripsy candidate 2) Age range 18 to 65 years 3) Perform extracorporeal lithotripsy for the first time 4) Signing an informed consent form. No entry conditions: 1) Have previous experience or knowledge of the effects of acupressure 2) Drug addiction 4) Existence of an obstacle at the site of pressure (wounds, skin diseases, etc)
Intervention groups
Study groups: Intervention group: In the intervention group, the massage intervention is performed at the Qiu acupuncture point located around the lumbocostal region for 3 minutes. The main outcome variables include the severity of nausea, pain and physiological indicators (including heart rate and blood pressure) of the patients are recorded. Control group: In the control group, massage intervention is performed in the neutral area and around the main point. Patients in both groups receive routine care.
Main outcome variables
Nausea, pain and physiological parameters

General information

Reason for update
Update based on pilot study results
Acronym
IRCT registration information
IRCT registration number: IRCT20190524043687N4
Registration date: 2023-05-03, 1402/02/13
Registration timing: prospective

Last update: 2024-01-10, 1402/10/20
Update count: 1
Registration date
2023-05-03, 1402/02/13
Registrant information
Name
Ali Safdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 5861 5962
Email address
asafdari.nu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on the intensity of nausea, pain and physiological parameters of patients treated with extracorporeal lithotripsy
Public title
The effect of acupressure on the intensity of nausea, pain and physiological parameters of patients treated with extracorporeal lithotripsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Eligible for with extracorporeal lithotripsy according to the doctor's diagnosis Signing an informed consent form The age range of 18 to 65 Perform extracorporeal lithotripsy for the first time
Exclusion criteria:
Have previous experience or knowledge of the effects of acupressure Lack of full consciousness Having mental, visual and auditory disorders and neuropathy Drug addiction Existence of an obstacle at the site of pressure (wounds, skin diseases, etc)
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block randomization method with unequal blocks. will be used - Randomization unit: individual - How to build a random sequence: An equal number of each group will be placed in each block. In this way, first, the list of all permutations related to the size of the desired block is determined and then will be randomly as many as the number of samples from the permutation. The method used to generate the random allocation sequence is using a computer. The method of concealing the allocation is to use sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The blind groups in this study include patients and an assistant research collector; in such a way that none of the patients and the data collector will be aware of the allocation of patients to the two intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethical Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Science, Shahid Fahmide Boulevard, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2023-04-29, 1402/02/09
Ethics committee reference number
IR.UMSHA.REC.1402.058

Health conditions studied

1

Description of health condition studied
Urinary stones
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney

Primary outcomes

1

Description
Intensity of pain
Timepoint
Before intervention, 1, 10, 20, 30, 40 and 50 minutes after the intervention
Method of measurement
Numeric pain rating scale

2

Description
Intensity of nausea
Timepoint
The intensity of nausea will be evaluated before and after extracorporeal shock wave lithotripsy
Method of measurement
Self-report scale

3

Description
Heart rate
Timepoint
Before intervention, 1, 10, 20, 30, 40 and 50 minutes after the intervention
Method of measurement
Number of beats per minute - pulse oximeter

4

Description
Blood pressure
Timepoint
Before intervention, 1, 10, 20, 30, 40 and 50 minutes after the intervention
Method of measurement
By sphygmomanometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in the intervention group will receive the intervention before the extra-organ stone crushing in the same place in a room with minimal environmental stimuli (such as sound, temperature, light, etc.) while respecting privacy. For this purpose, the researcher first takes out his watch and ring and washes and warms his hands, then stretches the paravanes around the patient's bed and the patient lies on the opposite side that is in pain so that the painful side of the patient faces the side. be placed above the patient's knees are slightly bent into the abdomen. Acupressure intervention in the present study is performed at the acupuncture point of Qiu. This point was first identified by Yunqiao Qiu, a urology specialist at a hospital affiliated with Guangzhou Medical University in China, for treating acute kidney colic pain. This anatomical point is located about the width of one finger (the size of the body is equivalent to 1.3 inches) below and one thumb's width inside the intersection of the twelfth rib and the column of vertebrae (Lumbo-costal point). After observing the location choosing the exact location and marking it with his thumb, the researcher presses a force in the direction of 45 degrees to the spine for 3 minutes. Thumb strength will be done gradually and with a regular rhythm until the patient feels warmth in the area. The massage intervention will be repeated once exactly before the commencement of lithotripsy. The results examined in this study are measured before massage and at 1, 10, 20, 30, 40, and 50 minutes.
Category
Treatment - Other

2

Description
Control group: In the control group, according to the protocol of the acupressure intervention group, they will receive massage intervention at the neutral point and around the main point.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr. Habibullah Mousavi Bahar
Street address
Shahid Beheshti Medical Center, at the beginning of Eram Boulevard, Ghaem Square, Hamadan
City
Hamadan
Province
Hamadan
Postal code
3371565179
Phone
+98 81 3838 0283
Email
Shahidbeheshti@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokouhi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shokoohi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ali Safdari
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0447
Email
asafdari.nu@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Reza Borzou
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0447
Email
Borzou@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ali Safdari
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0447
Fax
Email
asafdari.nu@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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