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The effect of meditation on anxiety and pain of non-emergency patients of renal crusher candidate

Protocol summary

Study aim
Determination and comparison of anxiety in non-pregnant patients of renal stone crusher in intervention and control groups before and after intervention. Determination of pain in non-pregnant patients of renal crusher candidate in intervention and control groups before and after intervention.
Design
Clinical trials with control group, community based and pragmatic, with parallel groups; double blind, randomized design.
Settings and conduct
Considering the effectiveness of meditation intervention in improving the anxiety and pain of patients with renal stone crusher. The researcher attended the Shahid Beheshti Hospital in Yasuj, Iran. At first, by introducing and expressing the research goals and obtaining a written informed consent from patients who entered the research, anxiety inventory was completed in the presence of the researcher. All eligible patients were admitted to the study, Nurse received meditation meditation training, but the control group did not receive any training.
Participants/Inclusion and exclusion criteria
Inclusion criteria: inclination to participate in research; kidney stones based on expert diagnosis; obtain more than 25 Hamilton anxiety inventory questionnaires. Exclusion criteria: not participating in the study; participate in similar interventions; non-attending mediation therapy sessions; acute infection; children.
Intervention groups
A researcher at the Shahid Beheshti Hospital in Yasuj participated in all of the interventions. Firstly, with the introduction of the research goals and the written informed consent of the patients who entered the research, anxiety inventory was completed in the presence of the researcher. All patients qualified to enter the study, nurse received meditation meditation training, but the control group did not receive any training.
Main outcome variables
Fan meditation, anxiety, pain, candidates, kidney crusher.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180410039255N1
Registration date: 2018-08-21, 1397/05/30
Registration timing: retrospective

Last update: 2018-08-21, 1397/05/30
Update count: 0
Registration date
2018-08-21, 1397/05/30
Registrant information
Name
Nasibe Mashhadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3744 6186
Email address
mashhadinasib@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-05, 1396/12/14
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
2018-03-05, 1396/12/14
Actual recruitment end date
2018-06-24, 1397/04/03
Trial completion date
empty
Scientific title
The effect of meditation on anxiety and pain of non-emergency patients of renal crusher candidate
Public title
The effect of meditation on anxiety and pain of patients who perform kidney stone
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Inclination to participate in research Kidney stones are diagnosed on the basis of a specialist diagnosis Earn more than 25 Hamilton anxiety inventory scores
Exclusion criteria:
Unwilling to participate in the study Participate in similar interventions Not attending meditation therapy sessions Acute infection Children
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Actual sample size reached: 73
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the University of Medical Sciences and Health Services of the province, Golveh a
Street address
Yasuj University of Medical Sciences, Hazrat Zaynab Nursing and Midwifery Faculty
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Approval date
2018-01-19, 1396/10/29
Ethics committee reference number
IR.YUMS.REC.1396.157

Health conditions studied

1

Description of health condition studied
Patients Candidate Kidney Crusher
ICD-10 code
ICD-10 code description
Renal stone

Primary outcomes

1

Description
Pain and anxiety
Timepoint
Before intervention, after intervention
Method of measurement
Anxiety Inventory and Visual Analog Scale

2

Description
Reduce pain and anxiety
Timepoint
Before intervention, 2 hours after intervention
Method of measurement
Hamilton anxiety inventory, pain intensity scale NRS

Secondary outcomes

1

Description
Timepoint
Method of measurement

Intervention groups

1

Description
Intervention group: perform meditation medication on patients with renal stone crusher according to entry criteria in 20 minutes in 1 session
Category
Behavior

2

Description
Control group: This group does not receive intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shaheed Beheshti Hospital in Yasuj
Full name of responsible person
Nasibeh Mashhadi
Street address
Yasuj Shahid Montazeri Street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 3333 7230
Fax
+98 24 1933 3374
Email
Nasibeh.mashhadi@yums.ac.ir
Web page address
http://ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Kheirollah nooryan
Street address
Motahhari Boulevard, Medical University
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7230
Email
khnooryan@gmail.com
Web page address
http://yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Nasibeh mashhadi
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 20, Kian alley, Janbazan
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591948435
Phone
+98 0317789181
Email
mashhadinasib@gmail.com
Web page address
http://yums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mashhadi Nasibe
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.20, Kian alley, plaque, Janbazan
City
Efahan
Province
Isfehan
Postal code
7591958435
Phone
+98 317789181
Email
mashhadinasib@gmail.com
Web page address
http://yums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mashhadi Nasibeh
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 20, Kian alley, Janbazan
City
Esfahan
Province
Isfehan
Postal code
7591958435
Phone
+98 317789181
Email
mashhadinasib@gmail.com
Web page address
http://yums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It is possible to share some of the data, such as information on the main consequence.
When the data will become available and for how long
Available after 6 months of printing results.
To whom data/document is available
Research data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Use of data and documentation to conduct further research and access to more complete results is permissible.
From where data/document is obtainable
You can contact us by e-mail
What processes are involved for a request to access data/document
Request to receive data or documentation by email. As soon as possible, access to the requested files is available.
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