Protocol summary

Summary
Depression is the most common mental health problem in hemodialysis patients that can have a negative impact on patients' quality of life. This study aimed to determine the effect of acupressure on severity of depression in hemodialysis patients. Methods: This study is a randomized clinical trial. Ninety-six hemodialysis patients in hemodialysis wards of Noor, Shariati, and Al-Zahra Hospitals were selected by convenient sampling method and randomly divided into three groups (32 patients) of intervention, placebo, and control groups. Data collection tools included a demographic questionnaire and Beck Depression Scale. Acupressure in the intervention and placebo groups was performed over 4 consecutive weeks, 3 times a week, each session lasting 20 minutes during the first 2 hours of dialysis at 6 acupressure points; with this difference that in the placebo group intervention was performed with one centimeter distance away from the true points. The control group received usual care. For data analysis, descriptive statistics, inferential (ANCOVA and LSD) and SPSS software version 11.5 was used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015070523044N2
Registration date: 2016-04-06, 1395/01/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-06, 1395/01/18
Registrant information
Name
Leila Kalani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4242 3308
Email address
leilakalani@yahoo.com
Recruitment status
Recruitment complete
Funding source
School of Nursing and Midwifery, Isfahan University of Medical Sciences
Expected recruitment start date
2011-10-26, 1390/08/04
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on severity of depression in hemodialysis patients referred to hemodialysis units in hospitals of Isfahan in 2012
Public title
The Effectiveness of Acupressure on Severity of Depression in Hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age older than 18 years old; diagnosis of ERSD; undergoing hemodialysis at least for 3 months; the patients with chief complaine of fatigue and having fatigue score ≥5 based on fatigue severity visual analogue scale; lack of any wound or fracture; being in complete psychological and mental health to attend the study and fill the questionnaire, and not having undergone complementary medicine treatment in the past 3 months of the study. Exclusion criteria: patient’s absence for two sessions of acupressure intervention and lack of interest to continue the study.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Postal code
Approval date
2011-10-25, 1390/08/03
Ethics committee reference number
IR.MUI.REC.1390.30303

Health conditions studied

1

Description of health condition studied
Fatique in hemodialysis patients
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease, unspecified

Primary outcomes

1

Description
Fatigue
Timepoint
Before and two weeks after the intervention
Method of measurement
Piper Fatigue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention in intervention group was conducted in the first 2 h of hemodialysisin the experimental and placebo groups. This interventionwas carried out among the subjects regularly undergoinghemodialysis, in both legs, hands, and the waist in threeweekly sessions for 4 weeks.[18] In the experimental group,the intervention was conducted on the major acupoints K1,GB 34, ST 36, SP 6, BL 23, and HT7.[22,23] In the placebogroup, it was carried out with 1 cm distance from the majorabove-mentioned acupoints. Each session lasted for 20min, of which 2 min were devoted for primary superficialstroking of the acupoints[24] and the rest of the time (18min) was for acupressure of the determined six acupoints(3 min for each acupoint)
Category
Treatment - Other

2

Description
The control group received no specific action was performed only routine care
Category
N/A

3

Description
This intervention in the placebo group during the first 2 hours of hemodialysis. The intervention in both legs, both arms and waist and the people who were dialysis three times a week and regularly 3 sessions per week for 4 weeks was conducted. In the experimental group the main points of acupressure like k1, st36, sp6, bl23, ht7 and gb34. Each session lasted 20 minutes, 2 minutes Stroke initial surface to loosen the acupressure points and meridians and 18 minutes remaining open channels for pressing each of the six point (3 minutes anywhere) of these is a difference of the in the placebo group one centimeter away from the main point
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Leila Kalani
Street address
Shariati Hospital, Shariati St., Chahar Baghe Bala
City
Isfahan

2

Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Leila Kalani
Street address
Al-Zahra hospital, Sofe St.
City
Isfahan

3

Recruitment center
Name of recruitment center
Nour Hospital
Full name of responsible person
Leila Kalani
Street address
Nour Hospital, Ostandari St.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice President of Research, School of Nursing and Midwifery, Isfahan University of Medical Sciences
Full name of responsible person
Maryam Kianpour
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research, School of Nursing and Midwifery, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Leila Kalani
Position
MSc in Critical Care Nursing
Other areas of specialty/work
Street address
Dezful University of Medical Sciences
City
Dezful
Postal code
Phone
+98 61 4242 3308
Fax
Email
kalani.l@dums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Leila Kalani
Position
Master of Critical Care Nursing
Other areas of specialty/work
Street address
Dezful University of Medical Sciences
City
Dezful
Postal code
Phone
+98 61 4242 3308
Fax
Email
kalani.l@dums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
leila kalani
Position
Master of Critical Care Nursing operating room technology group president
Other areas of specialty/work
Street address
Dezful University of Medical Sciences
City
Dezful
Postal code
Phone
+98 61 4242 3308
Fax
Email
kalani.l@dums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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