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The effect of acupressure on the severity of functional constipation in elderly women referring to the medical clinic Hospital of Social Security in Bojnourd 1397

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History
# Registration date Revision Id
2 2019-04-20, 1398/01/31 91824
1 2019-02-03, 1397/11/14 77908
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  • Protocol summary

    Treatment
    Determining the effect of acupressure on the severity of constipation in women aged 50-70 years who referred to the Social Security Clinic of the City of Bojnordar 1398-1397
    درمانی
    تعیین تاثیر طب فشاری بر شدت یبوست عملکردی زنان 70-50 سال مراجعه کننده به کلینیک درمانی تامین اجتماعی شهربجنورد 1398-1397

  • General information

    70 people aged 50-70 years old who were referred to the medical clinic Hospital of Social Security who suffered from constipation or other complaints but at the same time suffered from constipation were selected based on objective sampling and randomly assigned to two groups: control and Intervention is divided into 35 people. The intervention group carries out a routine therapeutic approach as well as acupressure training at designated points for 4 weeks, and the control group also performs the usual treatment. Constipation is the main outcome variable in this study..
    70 people aged 50-70 years attending a social welfare clinic who suffer from constipation or other complaints, but at the same time suffering from constipation, are selected based on objective sampling and each person has a proprietary code given by A statistic consultant is provided in blocks 2 and unaware of which code belongs to which group is placed in the envelope (with random allocation based on the referral of patients) and the subjects are randomly assigned to two groups of control and intervention Get it The intervention group carries out a routine treatment approach plus acupressure at the designated points for 4 weeks, and the control group also has a common therapeutic approach. And questionnaires are completed before and after the intervention by a researcher who is unaware of the intervention and control group. Constipation is the main variable in this studyp also performs the usual treatment.
    70 نفر از افراد 70-50 سال مراجعه کننده به کلینیک درمانی بیمارستان تامین اجتماعی که مبتلا به یبوست و یا شکایت دیگری ولی در عین حال از یبوست رنج می برند بر اساس نمونه گیری مبتنی بر هدف انتخاب و به طور تصادفی به دو گروه کنترل و مداخله تقسیم می شوند. گروه مداخله رویکرد درمانی معمولی بعلاوه انجام طب فشاری در نقاط تعیین شده را به مدت 4 هفته انجام میدهد و گروه کنترل نیز رویکرد درمانی معمولی را دارد. یبوست متغیر اصلی در این مطالعه است.
    70 نفر از افراد 70-50 سال مراجعه کننده به کلینیک درمانی بیمارستان تامین اجتماعی که مبتلا به یبوست و یا شکایت دیگری ولی در عین حال از یبوست رنج می برند بر اساس نمونه گیری مبتنی بر هدف انتخاب و به هر نفر یک کد اختصاصی که توسط مشاور آمار در بلوک های 2تایی و بی خبر از این که کدام کد مربوط به کدام گروه می باشد در پاکت قرار گرفته است داده می شود (با تخصیص تصادفی بر اساس مراجعه بیماران ) و افراد به طور تصادفی در دو گروه کنترل و مداخله قرار می گیرند. گروه مداخله رویکرد درمانی معمولی بعلاوه انجام طب فشاری در نقاط تعیین شده را به مدت 4 هفته انجام میدهد و گروه کنترل نیز رویکرد درمانی معمولی را دارد. و پرسشنامه ها نیز قبل و بعد از مداخله توسط کمک پژوهشگر که بی اطلاع از گروه مداخله و کنترل است تکمیل می شود. یبوست متغیر اصلی در این مطالعه است .

  • Recruitment centers

    #1
    Name of recruitment center - English: Clinic of Samen Alaemah Hospital (Social Security)
    Name of recruitment center - Persian: درمانگاه بیمارستان ثامن الائمه(تامین اجتماعی)
    Full name of responsible person - English: Zohreh Nazari Kushaki
    Full name of responsible person - Persian: زهره نظری کوشکی
    Street address - English: Chamran St.- Samen Al-Amaem Hospital (Social Security)
    Street address - Persian: خیابان چمران- بیمارستان ثامن الائمه(تامین اجتماعی)
    City - English: Bojnord
    City - Persian: بجنورد
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 74877-94149
    Phone: +98 58 3223 1852
    Fax:
    Email: z.nazari1126@gmail.com
    Web page address:
    Name of recruitment center - English: Clinic of Samen Alaemah Hospital (Social Security)
    Name of recruitment center - Persian: درمانگاه بیمارستان ثامن الائمه(تامین اجتماعی)
    Full name of responsible person - English: Zohreh Nazari Kushaki
    Full name of responsible person - Persian: زهره نظری کوشکی
    Street address - English: Samen Alaemah Hospital (Social Security), Chamran Street
    Street address - Persian: خیابان چمران- بیمارستان ثامن الائمه(تامین اجتماعی)
    City - English: Bojnord
    City - Persian: بجنورد
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 74877-94149
    Phone: +98 58 3223 1852
    Fax:
    Email: z.nazari1126@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Seyed Kaveh Hojjat
    Full name of responsible person - Persian: دکتر سید کاوه حجت
    Street address - English: Bojnourd - Government Boulevard, Central Building of North Khorasan University of Medical Sciences
    Street address - Persian: بجنورد- بلوار دولت، ساختمان مرکزی دانشگاه علوم پزشکی خراسان شمالی
    City - English: Bojnord
    City - Persian: بجنورد
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 74877-94149
    Phone: +98 58 3229 7156
    Fax:
    Email: k.hojjat@nkums.AC.IR
    Web page address: htpp://research.nkums.ac.ir

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Seyed Kaveh Hojjat
    Full name of responsible person - Persian: دکتر سید کاوه حجت
    Street address - English: Central building of North Khorasan University of Medical Sciences, Government boulevard, Bojnourd
    Street address - Persian: بجنورد- بلوار دولت، ساختمان مرکزی دانشگاه علوم پزشکی خراسان شمالی
    City - English: Bojnord
    City - Persian: بجنورد
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 74877-94149
    Phone: +98 58 3229 7156
    Fax:
    Email: k.hojjat@nkums.AC.IR
    Web page address: htpp://research.nkums.ac.ir

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zohreh Nazari Kushaki
    Full name of responsible person - Persian: زهره نظری کوشکی
    Position - English: student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Central building of North Khorasan University of Medical Sciences, Government boulevard, Bojnourd
    Street address - Persian: بجنورد- بلوار دولت ، ساختمان مرکزی دانشگاه علوم پزشکی خراسان شمالی
    City - English: Bojnord
    City - Persian: بجنورد
    Province: North Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 74877-94149
    Phone: +98 58 3241 8382
    Mobile: +98 915 186 1126
    Fax:
    Email: z.nazari1126@gmail.com
    Web page address: http://nkums.ac.ir/category/22227

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mahboubeh Tabatabaei chehr
    Full name of responsible person - Persian: محبوبه طباطبایی چهر
    Position - English: Academic staff
    Position - Persian: هیات علمی
    Latest degree: master
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Central building of North Khorasan University of Medical Sciences, Government boulevard, Bojnourd
    Street address - Persian: بجنورد- بلوار دولت ، ساختمان مرکزی دانشگاه علوم پزشکی خراسان شمالی
    City - English: Bojnord
    City - Persian: بجنورد
    Province: North Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 74877-94149
    Phone: +98 58 3229 7097
    Mobile: +98 915 584 4336
    Fax:
    Email: chehr192@gmail.com
    Web page address: http://nkums.ac.ir/category/22227

Protocol summary

Study aim
Determining the effect of acupressure on the severity of constipation in women aged 50-70 years who referred to the Social Security Clinic of the City of Bojnordar 1398-1397
Design
It has two groups of control and intervention - targeting based sampling Randomization Based on 2-Blocks and 2-Blind (Assisted Researcher and Data Analyzer)
Settings and conduct
In the clinic of Social Security Hospital based on purpose-based sampling
Participants/Inclusion and exclusion criteria
Equivalent to the study: Patients are in the age group of 70-70, mentally conscious and capable of answering questions, postmenopausal, having constipation according to Roman III criteria, lack of history of the diseases listed in the study, non-addiction Drugs and alcohol, absence from the nursing home (due to the lack of control and intervention of the control group and easy access to the samples), exclusion criteria: incidence of emergency and side effects during the intervention, diet change Elimination of constipation during the intervention period, failure to implement acupressure program more than 3 consecutive times per week, mental, psychological, Varian, divorce, travel, the patient died.
Intervention groups
The intervention group is a routine therapeutic approach, as well as acupressure training at designated points for 4 weeks, and the control group has a common therapeutic approach.
Main outcome variables
Severity of constipation, acupressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190117042393N1
Registration date: 2019-02-03, 1397/11/14
Registration timing: registered_while_recruiting

Last update: 2019-05-29, 1398/03/08
Update count: 1
Registration date
2019-02-03, 1397/11/14
Registrant information
Name
Zohreh Nazari Koushki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3241 8382
Email address
z.nazari@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on the severity of functional constipation in elderly women referring to the medical clinic Hospital of Social Security in Bojnourd 1397
Public title
acupressure on the severity of functional constipation in elderly women
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
1-Patients in the age range of 50-70 years 2- Mentally minded and able to answer questions. 3 - Have a chance 4 - Constipation according to Rome III. 5. Lack of history of diseases, spinal cord injuries, inflammatory digestive diseases, gastrointestinal obstructive diseases, gastrointestinal bleeding, lupus erythematosus, Parkinson's disease, hypothyroidism, hyperparathyroidism, advanced leg legs, thrombophlebitis, bone marrow, non-use of anti-Parkinson drugs, Psychiatric disorders according to medical records, acute stress disorder, pituitary gland palsy, sympathomimetics, lack of history of anti diarrhea drugs, psychotropic drugs and no history of injury in the abdomen and legs and arms during the last two years and lack of medication Constipation causes iron, if necessary, tests Laboratory Rmal like TSH, lack of blood in the stool, normal liver enzyme alkaline phosphatase, and normal WBC, and pelvic floor problems, no history of serious illness. 6. Non-drug and alcohol addiction 7. Absence in the nursing home (due to the lack of control and intervention and the easy access to samples)
Exclusion criteria:
1- Emergency and side effects during the intervention 2- Diet change to relieve constipation during the intervention period. 3. Failure to perform acupressure program more than 3 times a week. 4. Critical psychological, psychological, mourning, divorce, travel, patient death.
Age
From 50 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
70 people aged 50-70 years attending a social welfare clinic who suffer from constipation or other complaints, but at the same time suffering from constipation, are selected based on objective sampling and each person has a proprietary code given by A statistic consultant is provided in blocks 2 and unaware of which code belongs to which group is placed in the envelope (with random allocation based on the referral of patients) and the subjects are randomly assigned to two groups of control and intervention Get it The intervention group carries out a routine treatment approach plus acupressure at the designated points for 4 weeks, and the control group also has a common therapeutic approach. And questionnaires are completed before and after the intervention by a researcher who is unaware of the intervention and control group. Constipation is the main variable in this studyp also performs the usual treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
1-The researcher's assistance completes the questionnaires before intervention and 4 weeks after the intervention and unaware of the control and intervention group. 2-The data analyzer also analyzes the data without knowing the control group and interfering them with the code given to them
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of North Khorasan University of Medical Sciences
Street address
Central building of North Khorasan University of Medical Sciences, Government boulevard, Bojnourd
City
Bojnord
Province
North Khorasan
Postal code
74877-94149
Approval date
2018-09-26, 1397/07/04
Ethics committee reference number
IR.NKUMS.REC.1397.041

Health conditions studied

1

Description of health condition studied
Constipation
ICD-10 code
k90-k93
ICD-10 code description
Other diseases of the digestive system

Primary outcomes

1

Description
Score the severity of the constipation
Timepoint
At the beginning of the study (before the start of the study) and 4 weeks after the start of the intervention
Method of measurement
Million and Williams constipation severity questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group receives the usual therapeutic approach and 4 weeks of acupressure twice a day by the individual.
Category
Treatment - Other

2

Description
Control group: The control group continues their usual treatment and does not receive an intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Samen Alaemah Hospital (Social Security)
Full name of responsible person
Zohreh Nazari Kushaki
Street address
Samen Alaemah Hospital (Social Security), Chamran Street
City
Bojnord
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3223 1852
Email
z.nazari1126@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr. Seyed Kaveh Hojjat
Street address
Central building of North Khorasan University of Medical Sciences, Government boulevard, Bojnourd
City
Bojnord
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 7156
Email
k.hojjat@nkums.AC.IR
Web page address
htpp://research.nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Zohreh Nazari Kushaki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Central building of North Khorasan University of Medical Sciences, Government boulevard, Bojnourd
City
Bojnord
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 7156
Email
z.nazari1126@gmail.com
Web page address
http://nkums.ac.ir/category/22227

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mahboubeh Tabatabaei chehr
Position
Academic staff
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Central building of North Khorasan University of Medical Sciences, Government boulevard, Bojnourd
City
Bojnord
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 7097
Email
chehr192@gmail.com
Web page address
http://nkums.ac.ir/category/22227

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Zohreh Nazari Kushaki
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Central building of North Khorasan University of Medical Sciences, Government boulevard, Bojnourd
City
Bojnord
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3241 8382
Email
z.nazari1126@gmail.com
Web page address
http://nkums.ac.ir/category/22227

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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