Protocol summary

Study aim
determine the effect of acupressure on anxiety and depression in hemodialysis patients
Design
Patients were randomly divided into two groups of intervention and control. Initially, the names of all patients were written on the sheet and then put in a glass, then out of order, divided into intervention and control groups.
Settings and conduct
This study was a clinical trial, conducted on 40hemodialysis patient's refferal to emam khomieni hospital. Acupressure in Intervention group will be done on true acupoints (PC6) by using 3 to 4 kg pressure, with the practitioners' thumb in a period of two revolutions per second.The intervention will conduct three times a week for a month.
Participants/Inclusion and exclusion criteria
age 18 years and above, six months hemodialysis history, medical record in hemodialysis center, doing hemodialysis three times in week, getting anxiety score beween 20 to 29 and depression 14 to 19 inclusion criteria: ampotation in site acupressure, chronic mental and pyshical disease, Unable to communicate
Intervention groups
In this clinical trial study, participation divide two intrvetion and control groups. Intervention group: Acupressure will be done on true acupoints (PC6) by using 3 to 4 kg pressure, with the practitioners' thumb in a period of two revolutions per second.The intervention will conduct three times a week for a month. In the control group, no action was taken during the intervention and routine interventions were received.
Main outcome variables
anxiety and depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160605028255N2
Registration date: 2020-06-06, 1399/03/17
Registration timing: retrospective

Last update: 2020-06-06, 1399/03/17
Update count: 0
Registration date
2020-06-06, 1399/03/17
Registrant information
Name
Jasem Allahyari
Name of organization / entity
Zabol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 437 5752
Email address
j.allahyari@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
2017-12-22, 1396/10/01
Actual recruitment end date
2018-01-21, 1396/11/01
Trial completion date
2018-02-20, 1396/12/01
Scientific title
THE EFFECT OF ACUPRESSURE AT P6 POINT ON ANXIETY AND DEPRESSION IN HEMODIALYSIS PATIENTS
Public title
THE EFFECT OF ACUPRESSURE AT P6 POINT ON ANXIETY AND DEPRESSION IN HEMODIALYSIS PATIENTS
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
having 18 years old Having at least 6 months history of hemodialysis having records in hemodialysis center dialysis three times in week achieving score anxiety between 20 to 29 and depression 14 to 19
Exclusion criteria:
ampotion in acupressure site Chronic physical and mental illness inability to commnucation usage sedation drugs patient death and death close relative
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
the name patients write on sheet then put in the glass and randomly select name and divide in two groups.
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 Zabol University of Medical Sciences
Street address
Nursing and midwifery school, Ferdosi street, Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Approval date
2017-06-22, 1396/04/01
Ethics committee reference number
zbmu.1.REC.1396.184

Health conditions studied

1

Description of health condition studied
ESRD Patients undergoing hemodialysis treatment
ICD-10 code
N18.5
ICD-10 code description
End stage renal disease

Primary outcomes

1

Description
depression and anxiety
Timepoint
Before and one month after intervention
Method of measurement
Beck Depression Inventory and Spielberger Anxiety Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: perform acupressure three times in p6 point for four weeks
Category
N/A

2

Description
Control group:receive routine care
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hemodialysis center Imam Khomeini Hospital
Full name of responsible person
Mansour Zamani Afshar
Street address
Nursing and Midwifer school, Ferdosi street,
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 5402
Fax
+98 54 3223 2023
Email
info@zbmu.ac.ir
Web page address
http://www.zbmu.ac.ir/fa/contactus

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mansour Zamani Afshar
Street address
Nursing and midwifery school, Ferdosi street,
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 5402
Fax
+98 54 3223 2023
Email
Abcdeh2130@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
zabol university and 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
Zabol University of Medical Sciences
Full name of responsible person
Mansour Zamani Afshar
Position
psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Nursing and midwifery school, Ferdosi street. Zaol city
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3223 2023
Email
Abcdeh2130@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mansour Zamani Afshar
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Nursing and midwifer school, Ferdosi street, Zabol city
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 5402
Email
abcdeh2130@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mansour Zamani Afshar
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Nursing and midwifery school, Ferdosi street, Zabol city
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 5402
Email
abcdeh2130@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
Not applicable
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