Protocol summary

Summary
This is an interventional study with pre-test and post-test design with control group. The research population consists of patients aged 18 to 60 who are undergoing hemodialysis in the Namazi Hospital and the Faqih Hospital in Shiraz. In the first session, after obtaining informed consent, the demographic characteristics questionnaire and the Ellison and Palutzin’s Spiritual Health Questionnaire and Miller's hope scale are completed by the samples. At first, the control group is studied and without intervention, one month after completion of the first one, the questionnaires are completed by the control group. In intervention group, spiritual interventions are performed based on the nursing process. At first, patients' spiritual assessment is performed by interviews with the patient based on the FICA Standard Assessment Method and the spiritual needs are determined and based on the interventions will be provided. Some of the interventions include providing the book of the Qur'an and the opportunity to pray and perform the rituals by creating a suitable environment and, if desired, the audio file of the Qur'an and also the headphones are available for the patient. The patient is encouraged to participate in favorite groups, to communicate with others, to contemplate and reflect about himself or herself, to find positive points and capabilities, and to discover his or her feelings. The evaluation of interventions is based on spiritual wellbeing and hope questionnaires. Duration of interventions is 60 to 90 minutes twice a week for one month during dialysis. The questionnaires are completed one week after the end of the interventions again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017072317546N9
Registration date: 2017-08-15, 1396/05/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-08-15, 1396/05/24
Registrant information
Name
Marzieh Momennasab
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
momennasab@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual interventions on spiritual health and hope among the hemodialysis patients
Public title
The effect of spiritual interventions on spiritual health and hope among the hemodialysis patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: 1- Age of 18 to 60. 2. Not afflicted with known cognitive and psychological disorders. 3. The language of the patient is Farsi and has at least the ability to read and write. 4. Undergone hemodialysis twice or three times a week for three to four hours. 5. Do not have life-threatening illnesses like cancer. 6. The patient has the tendency to participate in the research and sign an informed consent form. Exclusion criteria: 1.Occurrence of a serious event or experience during the study for the patient. 2. Undergoing a kidney transplantation.3. A serious physical illness occurs in the course of study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz Street is Zand
City
shiraz
Postal code
14336 - 71348
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
IR.SUMS.REC.1396.77

Health conditions studied

1

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

Primary outcomes

1

Description
Spiritual health
Timepoint
Before and one month after the intervention
Method of measurement
Ellison and Palutzin's spiritual well-being questionnaire

2

Description
Hope
Timepoint
Before and one month after the intervention
Method of measurement
Miller's Scale

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In the beginning, the control group is being studied because environmental changes must be done for the intervention group of. The control group do not received any intervention and routine care were done.This group fills the questionnaires at the beginning of the study and one month later.
Category
Other

2

Description
Intervention group: In the intervention group, spiritual interventions are carried out based on the nursing process (assessment, diagnosis, planning, implementation and evaluation). At first, patients' spiritual assessment is performed during an interview with the patient based on the FICA standard assessment method. Since spirituality involves communicating with God, others, self and nature, and finding meaning and purpose, interventions are provided in this direction. Some interventions are providing opportunity for pray and reading and listening Quran, providing a religious advisor is on-site or on-call, encouraging the patient to participate in favorite groups and interact with others and so on. The interventions will be based on the patient's need. The evaluation of interventions is based on spiritual wellbeing and hope questionnaires. Duration of interventions is 60 to 90 minutes twice a week for one month during hemodialysis. Questionnaires will be completed one week after the end of the interventions again.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
mohammad Haghparasti
Street address
Namazai Square
City
shiraz

2

Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
mohammad Haghparasti
Street address
Zand Blv.
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of Research of Shiraz Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Shiraz Street is Zand
City
shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research of Shiraz 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
Faculty of Nursing and Midwifery, Fatemeh
Full name of responsible person
Dr. Marzieh Momennasab
Position
Assistant Professor
Other areas of specialty/work
Street address
Namazi Square, Faculty of Nursing and Midwifery, Hazrat Fatemeh
City
shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
momennasab@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Marzieh Momennasab
Position
Assistant Professor
Other areas of specialty/work
Street address
Namazi Square, Faculty of Nursing and Midwifery, Fatemeh (First Class)
City
shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
momennasab@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Fatemeh
Full name of responsible person
Mohammad Haghparasti Jahromi
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Namazi Square, Faculty of Nursing and Midwifery, Fatemeh (First Class)
City
shiraz
Postal code
Phone
00
Fax
Email
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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