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Investigating the effect of spiritual self-care education on anxiety and life expectancy of patients after bone marrow transplantation

Protocol summary

Study aim
Determining the effect of spiritual self-care training on anxiety and life expectancy after BMT
Design
A clinical trial study with a control group and without blinding, the method of randomization is block random sequence, and the sample size is 60 people, who are divided into two intervention and control groups of 30 people using sealed letters
Settings and conduct
The people in the intervention group are given the necessary training on spiritual self-care, and these classes are conducted on the Internet by a spiritual care specialist in 6 sessions of 60 minutes, before and after, we ask people to answer two questionnaires (anxiety and Life expectancy).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Receiving a BM; Age between 18-64 ;Not suffering from acute BMT complications ;Consent to participate in the study; Must be a Muslim(Shia religion) ;Ability to speak, read and write in Persian Exclusion criteria: having anxiety or mental disorder; Participation in spiritual care courses
Intervention groups
Intervention group: including 30 people who met the conditions for entering the study and underwent BMT, in addition to routine hospital care after discharge, in spiritual care sessions taught by an expert in this work in at least 6 sessions They participate in 60-minute sessions. In these sessions, topics such as strengthening the real relationship with God, teaching patience, achieving self-esteem, strengthening the relationship with others, and strengthening the relationship with nature are discussed. Control group: including 30 people who met the conditions for entering the study and underwent BMT, receive only routine hospital care after discharge, and at the end of the intervention, all spiritual care sessions are recorded in video format. These people are placed
Main outcome variables
Anxiety; life expectancy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240205060909N1
Registration date: 2024-10-06, 1403/07/15
Registration timing: prospective

Last update: 2024-10-06, 1403/07/15
Update count: 0
Registration date
2024-10-06, 1403/07/15
Registrant information
Name
zohre shoorvazdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4261 9727
Email address
zohre.shoorvarzi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-10, 1403/07/19
Expected recruitment end date
2024-10-30, 1403/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of spiritual self-care education on anxiety and life expectancy of patients after bone marrow transplantation
Public title
Spiritual self-care education after bone marrow transplantation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Receive a bone marrow transplant Age between 18-64 years Absence of acute bone marrow transplant complications Consent to participate in the study Muslim and Shia religion Ability to speak, read and write in Persian
Exclusion criteria:
Having known anxiety disorder or mental illness Participation in spiritual care courses
Age
From 18 years old to 64 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
After visiting the Bone Marrow Transplant(BMT) Clinic of Shariati Hospital, people who meet the entry criteria are selected and after necessary explanations and obtaining informed consent, they are randomly grouped into two control and intervention groups. The website https://www.sealedenvelope.com is used to generate the block random sequence and sealed opaque envelopes are used to hide the random allocation. Each of the generated random sequences is recorded on a card and the cards are placed in the letter envelopes. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. The lids of the letter envelopes are glued and placed in a box respectively. The participants open one of the envelopes and enter one of the groups based on it.
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
Research Institute of Oncology, Hematology and Tuberculosis Therapy, Tehran University of Medical Sc
Street address
North Kargar St., Jalal Al Ahmad Street, in front of Faculty of Economics, Dr. Shariati Research and Treatment Center, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2023-12-12, 1402/09/21
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1402.044

Health conditions studied

1

Description of health condition studied
Patients after bone marrow transplantation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
ََAnxiety
Timepoint
Before the intervention, four weeks after the intervention
Method of measurement
State-Trait Anxiety Inventory (STAI)

2

Description
Life expectancy
Timepoint
Before the intervention, four weeks after the intervention
Method of measurement
Miller hope scale (MHS)

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group consists of 30 people who are grouped into three groups of 10 people. Our intervention is the training of the spiritual self-care program, which is done by a spiritual care specialist. The duration of the intervention is 6 weeks in the form of 60-minute sessions .In the first session, the goal is to introduce and familiarize the members of the group and the leader to each other, in the second session, the goal is to improve and strengthen the relationship with God, and in the third session, to teach patience and its difference with tolerance. In the fourth session, the goal is to strengthen and connect with oneself and to achieve self-esteem. The fifth is strengthening communication with others and preparing people for the end of the sessions, and the sixth session is improving and strengthening communication with nature, and in each session, the patients do the tasks that have been said, including communication techniques, waiting, etc., and in the session They give feedback later.Before and after the intervention, the participants must answer two anxiety and life expectancy questionnaires
Category
Other

2

Description
The control group: includes 30 people who met the conditions for entering the study, but they were not taught the spiritual self-care program and only answered the anxiety and life expectancy questionnaire before and after the intervention. It should be noted that after At the end of the study, the file of all sessions is provided to the intervention group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
karimi rozveh , Ali
Street address
North Kargar St., Jalal Al Ahmad Street, in front of Faculty of Economics, Dr. Shariati Research and Treatment Center, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz.Granmaye
Street address
Tehran Province, Tehran, District 6, Nosrat St,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
fnm@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zohre.Shoorvazdi
Position
Master student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran Province, Tehran, N St, No. 18, Kargar, Iran
City
Tehran
Province
Tehran
Postal code
1439355975
Phone
+98 21 8801 6071
Email
shoorvazdizohre@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zohre.shoorvazdi
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran Province, Tehran, N St, No. 18, Kargar, Iran
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 21 8801 6071
Email
nrzohre.shoorvazdi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zohre.shoorvazdi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran Province, Tehran, N St, No. 18, Kargar, Iran
City
Tehran
Province
Tehran
Postal code
1739955975
Phone
+98 21 8801 6071
Email
shoorvazdizohre@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data of the people participating in the study that is related to the outcome will be published
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and medical centers
Under which criteria data/document could be used
Use with references Compliance with ethical protocols
From where data/document is obtainable
For the convenience of patients, they can contact the contact number of the responsible author. 09916669162 Zohre Shoorvazdi.
What processes are involved for a request to access data/document
From the time of sending the written request, she will have access to the data for a maximum of two weeks if the protocols are followed.
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