This study is a randomised clinical trial ( no blind) . the aim of the present study is to determine the effect of comfort-oriented nursing care on comfort level and quality of life in hemodialysis patients. The study population is all hemodialysis patients who refereed to hemodialysis center of Ferdows Chamran doctor hospital. 40 patients were randomly divided into control and intervention groups. Randomization in this study was conducted using a throw coins. This study will implement in Chamran doctor Hospital Dialysis Center. The main inclusion criteria include: receiving haemodialysis three times per week and at least 6 months of dialysis. At first, questionnair of haspice comfort and questionnaire for quality of life of patients in both intervention and control groups will be recorded. Patients problems are categorised in 4 groups as: physical, psychological, social and environmental discomfort, described in kolkaba table 3 in 4; in which, back massage for 5 to 15 minutes in the last hour of dialysis session. Massage of male patients will be done by male nurse and massage of female patients will be done by female nurse. is used to relieve physical discomfort; and having a company and educating patient through face to face consultation and pamphlet, is considered as psychological support.Intervention is applied for 6 consecutive sessions and control group will receive no specific intervention.assessment of comfort will be measure refilled after the final session,and quality of life will takes place after 2 months. Comfort and quality of life scores before and after intervention will be compared between 2 groups and in each group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016103130607N1
Registration date:2017-03-15, 1395/12/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-15, 1395/12/25
Registrant information
Name
Akram Momeni
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3288 2924
Email address
momeni.akram@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Birjand University of Medical Sciences
Expected recruitment start date
2016-11-15, 1395/08/25
Expected recruitment end date
2017-01-14, 1395/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of comfort based nursing cares among hemodialysis patients on their quality of life and comfort level
Public title
The effect of the comfort-oriented nursing care on comfort and quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: have an arteriovenous fistula or graft; receiving haemodialysis three times per week; Having at least 6 months of dialysis; perfect alertness and having willingness to cooperate in the study; age between 18 to 70; Lack of acute illnesses; ability to communicate verbally; intact skin at the massage.
Exclusion Criteria: Severe complications of hemodialysis; Guest of patients for dialysis; The reluctance of patients to continue working during the study; Communication Failure and disturbance of consciousness; any changes in the treatment planning; Death of patient.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization in this study was conducted using a throw coins
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ayatollah Ghaffari Street
City
Birjand
Postal code
9717853577
Approval date
2016-10-16, 1395/07/25
Ethics committee reference number
ir.bums.1395.108
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
N17, N18,
ICD-10 code description
Renal failure
Primary outcomes
1
Description
Comfort
Timepoint
Before and 2 weeks after intervention
Method of measurement
Questionnaire Hospitalized Comfort
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before intervention and 2 months after the intervention
Method of measurement
Questionnaire Kidney Disease Quality of Life
Intervention groups
1
Description
Intervention group:In this group 1- back massage will be done for 5 to 15 minutes in the last hour of dialysis session, during six consecutive sessions of dialysis by trained colleagues. Massage of male patients will be done by male nurse and massage of female patients will be done by female nurse.
2- Family involvement in the treatment process as an accompaniment during six consecutive sessions of dialysis
3. Educating the patient and family through face to face consultation and pamphlet during six consecutive sessions of dialysis patients will be conducted as required
Category
Treatment - Other
2
Description
Control group: There is no intervention in this group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis center of Chamran doctor hospital
Full name of responsible person
Reyhaneh Amozi, nursing expert
Street address
Dialysis center of Chamran doctor hospital, Motahari street
City
Ferdows
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Birjand University of Medical Sciences
Full name of responsible person
Gholamreza Sharifzade
Street address
Birjand University of Medical Sciences, Ayatollah Ghaffari Street
City
Birjand
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 of Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Akram Momeni
Position
Nursing expert, Master's students
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ayatollah Ghaffari Street
City
Birjand
Postal code
9717853577
Phone
+98 56 3243 0076
Fax
+98 56 3243 0076
Email
Momeni.akram@bums.ac.ir; momeniaa643@gmail.com
Web page address
www.bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Akram Momeni
Position
Nursing expert. Master's students
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ayatollah Ghaffari Street
City
Birjand
Postal code
9717853577
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
Momeni.akram@bums.ac.ir; momeniaa643@gmail.com
Web page address
www.bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Akram Momeni
Position
Nursing expert, Master's students
Other areas of specialty/work
Street address
Imam Ali Hospital, Shafa Street
City
Sarayan
Postal code
9789197761
Phone
+98 56 3288 1674
Fax
+98 56 3288 4004
Email
Momeni.akram@bums.ac.ir; momeniaa643@gmail.com
Web page address
www.bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)