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Comparison the effect of training using short massage services, face to face and booklet on knowledge and quality of life of patients under hemodialysis

Protocol summary

Summary
In this randomized controlled trial the knowledge and quality of life of patients under hemodialysis will be assessed by Chronic Hemodialysis Knowledge Survey and Kidney Disease Quality of Life-Short Form. This study will conduct by three groups, two intervention groups include face to face, short massage services training (SMS) and a control group with booklet, which will be chosen based on inclusion criteria, then will be allocated to groups randomly using random table counting. The participants with be selected among eligible patients (18-70 years) referring to hemodialysis of Sina Medical Educational Center of Tabriz in 2016. During first session, the aims of study will be explained. After getting informed consent, the researcher will complete knowledge and quality of life questionnaires of patients, by interview. For the face to face training group, four sessions in 10-15 minutes will be done one by one with a week interval, under hemodialysis. Also for tele-educational group an educational objective in the form of 3 SMS every day, totally 108 SMS will be sent within 36 days with the same educational content of face to face group in Persian with maximum of 160 characters per text message. The control group will receive common booklet training. For prevention of contact with other ones, the groups will be chosen from different shifts of hemodialysis. Six weeks after the intervention, all three groups will complete the questionnaire again. Finally, for blinding, the data will be collected then analyzed by a person unaware of training methods.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201508045665N6
Registration date: 2016-02-08, 1394/11/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-08, 1394/11/19
Registrant information
Name
Sima Lakdizaji
Name of organization / entity
Tabriz University of Medical Sciences, Nursing and Midwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0648
Email address
laks@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-02-04, 1394/11/15
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of training using short massage services, face to face and booklet on knowledge and quality of life of patients under hemodialysis
Public title
Comparison the effect of training with short massage services, face to face and booklet on knowledge and quality of life of patients under hemodialysis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with chronic renal failure undergoing hemodialysis; age between 18-70 years; history of at least 6 months of hemodialysis (4 hours) two or three times a week; literacy to read SMS; having a mobile phone for personal and necessary information on how to use it; lack of psychiatric disorders according to the patient's medical records; lack of vision problems in tele-educational group. Exclusion Criteria: to change the center of hemodialysis or living location; unwilling to continue at any time of the study; Kidney transplant surgery and termination of hemodialysis.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For prevention of contact with ones, each group will be chosen from different shifts of dialysis. As well as for blinding, data will be collected and analyzed by a person unaware of each groups training method. Also similar envelopes will be used for randomized allocation.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Ethics committee, Vice chancellor for research, Central building 2, Tabriz University of Medical Sciences, Golgasht Ave.
City
Tabriz
Postal code
Approval date
2015-10-26, 1394/08/04
Ethics committee reference number
TBZMED. REC.1394. 853

Health conditions studied

1

Description of health condition studied
Dialysis
ICD-10 code
Z49
ICD-10 code description
care involving dialysis

Primary outcomes

1

Description
Knowledge of patients
Timepoint
before intervention and six weeks after final intervention
Method of measurement
CHEKS (Chronic Hemodialysis Knowledge Survey)

Secondary outcomes

1

Description
Quality of life
Timepoint
before intervention and six weeks after intervention
Method of measurement
Kidney Disease Quality of Life-SF

Intervention groups

1

Description
During the first session, the aims of study will be explained to the patients. After informed consent form, the researcher will complete knowledge and quality of life questionnaires for hemodialysis patients, by interview. For the face to face training group, four sessions in 10-15 minutes will be done one by one with a week interval, under hemodialysis.
Category
Prevention

2

Description
The control group will receive the common dialysis ward training using booklet. After the intervention, all three groups will complete the questionnaire again. Finally, the questionnaires will be collected and the data will be analyzed using SPSS 22 software by a person unaware of training groups.
Category
Prevention

3

Description
For tele-educational group an educational objective in the form of 3 SMS every day, totally 108 SMS will be sent within 36 days with the same educational content of face to face group. Text messages will be in Persian and a maximum of 160 characters per message.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hemodialysis of Sina Medical Educational Center of Tabriz
Full name of responsible person
Pooia Tarverdizadeh Asl
Street address
Hemodialysis of Sina Medical Educational Center, Azadi Ave.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Rashidi
Street address
Vice Chancellor for research, Central Building 2, Tabriz University of Medical Sciences, Golgasht Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
PhD\ Research Deputy of Tabriz Nursing Faculty
Other areas of specialty/work
Street address
Tabriz Nursing and Midwifery Faculty, South Sharati Ave.
City
Tabriz
Postal code
5137947977
Phone
+98 41 3479 7713
Fax
Email
mirghafourvandm@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sima Lakdizaji
Position
Lecturer/ MSc in Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, South Sharati Ave.
City
Tabriz
Postal code
5138947977
Phone
+98 41 3477 0648
Fax
Email
laks@tbzmed.ac.ir AND sima.lak90@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sima Lakdizaji
Position
Lecturer/ MSc in Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, South Sharati Ave.
City
Tabriz
Postal code
5138947977
Phone
00
Fax
+98 41 3479 6969
Email
sima.lak90@gmail.com
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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