Goal: effects of spiritual care on life expectancy and death anxiety of patients undergoing hemodialysis with end-stage chronic renal failure in the case and control group
Design of the study: Randomized
Population of the study: Patients undergoing hemodialysis with end-stage chronic renal failure
Sample size: Sixty patients
Interventions: Effects of spiritual care on life expectancy and death anxiety
Blinding: Not blinded
Trial phase: 2-3
Study Design: Interventional
One central
Primary outcome measure: Life expectancy and Death anxiety
Inclusion criteria of the study: 1. end-stage chronic renal failure confirmed by the physician, 2. knowing the diagnosis and prognosis of their disease.
Exclusion criteria of the study: 1. incidence of any stressful event for patients once the study has begun, 2. unwillingness to continue the study for any reason.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030826961N1
Registration date:2016-05-22, 1395/03/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-22, 1395/03/02
Registrant information
Name
Shila Amini
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 988138380320
Email address
sh.amini@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Government sources
Expected recruitment start date
2016-07-05, 1395/04/15
Expected recruitment end date
2016-08-05, 1395/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the spiritual care on life expectancy and death anxiety in patients with end-stage chronic kidney disease under hemodialysis
Public title
The Effect of Spiritual Care on Life Expectancy and Death Anxiety in Hemodialysis patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria of the study: 1. end-stage chronic renal failure confirmed by the physician, 2. knowing the diagnosis and prognosis of their disease, 3. hemodialysis at least for 6 months, 4. having physical and mental capability of answering the questions, 5. not knowing the mental disorders diagnosed by the physician, and 6. having minimum ability of reading and writing.
Exclusion criteria of the study: 1. incidence of any stressful event for patients once the study has begun, 2. unwillingness to continue the study for any reason, and 3. hospitalization because of the disease relapse.
Age
From 15 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized: permutation block
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Beginning of Ayatollah Kashani Blvd,Khajeh Rashid Crossroads.
City
Hamadan
Postal code
Approval date
2016-03-03, 1394/12/13
Ethics committee reference number
IR.UMSHA.REC.1394.528
Health conditions studied
1
Description of health condition studied
End stage kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Death Anxiety
Timepoint
Before and one month after the start of the study
Method of measurement
Templer Death Anxiety Questionnaire
2
Description
Life Expectancy
Timepoint
Before and one month after the start of the study
Method of measurement
Life Expectancy Schneider Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The case group: (1): The case group will receive spiritual care besides the routine treatments.
The patients in the case and control group will complete a demographic information questionnaire before the intervention. The patients in the case and control group will also complete the Templer’sdeath anxiety scale and Schneider’s life expectancy scale before and after the intervention. Mean score of death anxiety and life expectancy of the two groups before and after the intervention will be eventually presented and compared. Prior to implementation of the spiritual care program, library resources and articles will be reviewed to prepare a care training package (booklets and CDs) for hemodialysis patients in the case group. The spiritual care program in this study will be held in four one-hour sessions individually twice a week in the morning or evening shift at bedside in the hemodialysis ward. The spiritual care model in the case group will include the following items: A- supportive presence involving the following items: 1. developing trust, empathy, and honesty between nurses and patients to establish a good relationship during sessions, 2. carefully listening to the patients’words, concerns, and fears, 3. supporting the patients spiritually and mentally, 4. enhancing patients’ hope and inner forces, 5. uttering positive sentences and reinforcing sound constructive thoughts, 6. communicating with patients verbally and non-verbally, 7. answering patients’ questions, explaining the course of treatment to the patients, and providing them with information on their disease in order to diminish their physical and mental stresses, and 8. encouraging the patients to use recreational places, B- support patients’ rituals: 1. helping the patients to find meaning of their life and the fact that no event is out of the divine providence, 2. providing necessary facilities for doing religious practices (including a turbah and a prayer rug and recommending patients’ family to help the patients in saying prayers), 3. encouraging the patients to say prayers and read Quran, 4. encouraging the patients to express their religious beliefs, and 5. encouraging the patients to talk with clergymen, and C- use of supportive systems: 1. encouraging the patients to communicate with people with whom they feel comfortable, 2. supporting the patients emotionally on the part of patients’ family and medical team such that the patients feel valued, including loving, accepting, and respecting them, 3. recommending patients’ family to help the patients do their daily activities, such as household chores, and 4. encouraging the patients to go to work. It should be noted that the first session involve principles on the supportive presence. The support for patients’ rituals will be emphasized in the second session. The third session will be dedicated to patients’ use of specific supportive systems. The materials taught in the first three sessions will be concluded in the fourth session, and the patients will be requested to express their views and questions about the spiritual care provided for them. It will be tried to obviate any ambiguity that may arise about the training materials.
Category
Lifestyle
2
Description
The control group (Group 2): This group will receive the routine medical and nursing care. Contains Hemodynamic monitoring During Hemodialysis، Correct hemodialysis and Control complications of hemodialysis.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Medical Educational Center
Full name of responsible person
Shila Amini
Street address
Beginning Eram Blvd،Ghaem Square
City
Hamadan
2
Recruitment center
Name of recruitment center
Beast Medical Eeducational Center
Full name of responsible person
Shila Amini
Street address
Shahid Beheshti Blvd
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Hamadan University of Medical Sciences
Full name of responsible person
Dr. Khudayar Oshvandi
Street address
nursing of College-Opposite the People's Park
City
Hamadan
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 Hamadan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Khodayar Oshvandi
Position
Nursing PHD
Other areas of specialty/work
Street address
College of nursing-Opposite the People's Park
City
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0320
Fax
+98 81 3838 0447
Email
oshvandi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Khodayar Oshvandi
Position
Nursing PHD
Other areas of specialty/work
Street address
College of nursing-Opposite the People's Park
City
hamadan-Opposite the People's Park
Postal code
38698-65178
Phone
+98 81 3838 0320
Fax
+98 81 3838 0447
Email
oshvandi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)