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Effects of Effleurage Massage on Intensity of physiological stress associated with the treatment in hemodialysis patients

Protocol summary

Summary
This study is a clinical trial on 41 patients undergoing hemodialysis.To evaluate the Effects of Effleurage Massage on Intensity of physiological stress associated with the treatment in hemodialysis patients . Inclusion criteria in this study were (A minimum of six months of dialysis, be able to communicate verbally and age above 18 years, no candidate for a kidney transplant and no history of physical stress (damage) and psychological (bereavement, grief, etc.) do not have a pacemaker, lack upper and lower limb amputation and even drugs are associated with mental . Then consent form to be filled. The patients will be randomly assigned to two groups. The questionnaire contains of demographic information and (HSS) . The correlation coefficient is 97/6. The stress include (muscle cramps, fatigue, itching, joint stiffness, soreness caused by inserting the needle, nausea and diarrhea and constipation). Before the intervention of stress is recorded in both groups.Then For each experimental group, in addition to the initial meetingTwo sessions will be held in private. Initially, the researcher training effleurage massage to care giver of patient.Three types of massage on the back ,Two neck massage, four hand massage and four foot massage. In addition,individuals will be given booklets. Each training session is 30 minutes.Therapeutic massage is a total of 12 sessions (each session twenty minutes)And one hour before bedtime is planned. No intervention for patients in the control group. Complete and delivery the questionnaire (HSS) by two group patients during a 4-week . Exclusion criteria unwillingness to continue the experimental ,use of drugs affecting mental illness, and hospitalization for any reason, surgery and infection in the study. Data were analyzed using SPSS software with Mann-Whitney, Chi-square, Friedman and sign test .The significance level was (0/05)

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014121520326N1
Registration date: 2015-01-08, 1393/10/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-08, 1393/10/18
Registrant information
Name
Mahdieh Arian
Name of organization / entity
North Khorasan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 6909
Email address
m.arian@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
North Khorasan University of Medical Sciences Assistance Research of North Khorasan University of Medical Sciences
Expected recruitment start date
2013-02-28, 1391/12/10
Expected recruitment end date
2013-05-17, 1392/02/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Effleurage Massage on Intensity of physiological stress associated with the treatment in hemodialysis patients
Public title
Effects of Effleurage Massage on physiological stress in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: at least six months of dialysis; ablility to communicate verbally; age over 18 years old; not being candidate for a kidney transplant; no history of physical stress (damage) and psychological (bereavement, grief, etc.); not having pacemaker; no amputation in lower or upper extermities; not taking psychiatric treatment medications. Exclusion criteria: unwillingness to continue in the study; use of drugs affecting mental illness, admission in hospital for any reason; surgery and infection during the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 41
Randomization (investigator's opinion)
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
North Khorasan University of Medical Sciences, Bojnurd,Iran
Street address
Building of the Central of north khorasan univesity of medical sciences
City
Bojnurd
Postal code
Approval date
2013-03-05, 1391/12/15
Ethics committee reference number
584/پ/91

Health conditions studied

1

Description of health condition studied
Hemodialysis patients
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis

Primary outcomes

1

Description
physiological stress
Timepoint
each week for 4 weeks
Method of measurement
questionnaire Hemodialys is Stress Scale(HSS)

Secondary outcomes

1

Description
muscle cramps, fatigue, itching, joint stiffness, soreness caused by inserting the needle, nausea and diarrhea and constipation
Timepoint
each week for 4 weeks
Method of measurement
questionnaire Hemodialys is Stress Scale(HSS).

Intervention groups

1

Description
Inclusion criteria in this study were (A minimum of six months of dialysis, be able to communicate verbally and age above 18 years, no candidate for a kidney transplant and no history of physical stress (damage) and psychological (bereavement, grief, etc.) do not have a pacemaker, lack upper and lower limb amputation and even drugs are associated with mental . Then consent form to be filled. 20 cases of patients who have conditions of entry will be randomly selected. Then, in a briefing before the intervention demographic and (HSS) questionnaire will be completed. For each experimental group, in addition to the initial meetingTwo sessions will be held in private. Initially, the researcher training effleurage massage to care giver of patient.Three types of massage on the back ,Two neck massage, four hand massage and four foot massage. In addition,individuals will be given booklets. Each training session is 30 minutes.Therapeutic massage is a total of 12 sessions (each session twenty minutes) And one hour before bedtime is planned. Complete and delivery the questionnaire (HSS) by patients during a 4-week . Exclusion criteria unwillingness to continue the experimental ,use of drugs affecting mental illness, and hospitalization for any reason, surgery and infection in the study
Category
Other

2

Description
Inclusion criteria in this study were (A minimum of six months of dialysis, be able to communicate verbally and age above 18 years, no candidate for a kidney transplant and no history of physical stress (damage) and psychological (bereavement, grief, etc.) do not have a pacemaker, lack upper and lower limb amputation and even drugs are associated with mental . Then consent form to be filled. 21 cases of patients who have conditions of entry will be randomly selected. Then, in a briefing before the intervention demographic and (HSS) questionnaire will be completed. No intervention for patients in the control group. Complete and delivery the questionnaire (HSS) by patients during a 4-week . Exclusion criteria unwillingness to continue the experimental ,use of drugs affecting mental illness, and hospitalization for any reason, surgery and infection in the study
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospitalin
Full name of responsible person
Street address
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
north khorasan univesity of medical sciences
Full name of responsible person
mahdi bakhshabadi
Street address
Building of the Central of north khorasan univesity of medical sciences, Dolat Bulvar, Bojnoord, north khorasan,Iran
City
bojnurd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
north khorasan univesity 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
North Khorasan University of Medical Sciences
Full name of responsible person
Mahdieh Arian
Position
Faculty member
Other areas of specialty/work
Street address
Building of the Central of north khorasan univesity of medical sciences, Dolat Bulvar, Bojnoord, north khorasan,Iran
City
Bojnurd
Postal code
Phone
+98 58 3226 9909
Fax
Email
m.arian@nkums.ac.ir; arianyem@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Mahdieh Arian
Position
Faculty member
Other areas of specialty/work
Street address
Building of the Central of north khorasan univesity of medical sciences, Dolat Bulvar, Bojnoord, north khorasan,Iran
City
Bojnord
Postal code
Phone
+98 58 3229 6909
Fax
Email
m.arian@nkums.ac.ir; arianyem@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Mahdieh Arian
Position
Faculty member
Other areas of specialty/work
Street address
Building of the Central of north khorasan univesity of medical sciences, Dolat Bulvar, Bojnoord, north khorasan,Iran
City
Bojnurd
Postal code
Phone
+98 58 3229 6909
Fax
Email
m.arian@nkums.ac.ir; arianyem@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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