Protocol summary

Study aim
Determining the effect of a compassion-based program on resilience of mothers of children with type 1 diabetes at the Endocrine and Metabolism Research Center of Isfahan in 2016
Design
This study is a two-stage, three-stage clinical trial. Sampling To divide the intervention and control groups, the random. allocation method with the help of SPSS software is used. 31 people in each group was obtained
Settings and conduct
The research environment is Isfahan Endocrine and Metabolism Research Center First, After the phone call and explanation and justification of the client, those who wish to cooperate are invited to visit the center. After referring to the center and completing the informed consent form by the participants in designing and determining the intervention and control group, it will be necessary to talk and coordinate with people about the time, place .
Participants/Inclusion and exclusion criteria
Inclusion criteria: having a child with type 1 diabetes - having the ability to understand the content and physical ability to participate in - having motivation to participate in - familiarity with the Persian language - not participating in other treatment or mental counseling - no disease Mental disorder Exclusion criteria:Reluctance to continue cooperation - not participating in more than one meeting.
Intervention groups
Each intervention session is held with the participation of 10-13 people. Number of intervention sessions: 8 sessions, with the titles of initial evaluation, compassion , forgiveness, acceptance, promotion of value sense, responsibility, skills training and final evaluation after the end of the research, if the control group wishes, intensive compassion therapy program , Will be held for them as well.
Main outcome variables
Perception of individual competenceو Trust in individual instincts وPositive acceptance وControl وSpiritual effects, Tabulation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201019049076N1
Registration date: 2020-12-12, 1399/09/22
Registration timing: retrospective

Last update: 2020-12-12, 1399/09/22
Update count: 0
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
Marzieh Najafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3568 3820
Email address
ma.na6144@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
2020-08-20, 1399/05/30
Actual recruitment end date
2020-09-20, 1399/06/30
Trial completion date
2020-12-20, 1399/09/30
Scientific title
The effect of a compassion-based program on resilience of mothers of children with type 1 diabetes in Isfahan Endocrine and Metabolism Research Center in 1399
Public title
The effect of compassion therapy on the resilience of mothers of children with type 1 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a child with type 1 diabetes Having the ability to understand the content mentally and the physical ability to participate in training sessions Having the motivation to participate in training sessions - familiarity with the Persian language Do not participate in other sessions of treatment or mental counseling at the same time Not having a mental disorder needs treatment
Exclusion criteria:
Reluctance to continue cooperation Do not attend more than one session
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 35
Actual sample size reached: 32
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the sample size, a random sequence is created with the help of SPSS software.In this way, in the data view menu, the desired number was entered in the 72nd row. In the variable view menu, we change the name of the variable (group) and set the number of decimal places to zero. In the Transform menu, select the Compute Variable option. In the Target Variable field, enter the name of the variable. In the Numeric Expression section, we entered the command (RV.BINOM (72,0.5), meaning that half of these 72 people are in the control group and half are in the intervention group. Then, to hide random allocation, each random sequence is recorded on a card and placed inside a completely sealed envelope. Then, in the order of the presence of each participant, one of the envelopes is selected and given to the same participant. This step is performed by another person in the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a parallel with Fixed size Design study

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of esfahan University of Medical Sciences
Street address
No 201, 26 Alley, falatoori Ave, esfahan Town
City
esfahan
Province
Isfehan
Postal code
8193769886
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.073

Health conditions studied

1

Description of health condition studied
Resilience of mothers with children with type 1 diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus

Primary outcomes

1

Description
Resilience score in Questionnaire
Timepoint
The effect of compassion therapy on resilience of mothers with children with type 1 diabetes at the beginning of the study (before intervention) and immediately and one month after intervention
Method of measurement
The effect of compassion therapy on resilience using Connor and Davidson questionnaire

Secondary outcomes

1

Description
Compassion score based on questionnaire
Timepoint
Periods of compassion measurement as a secondary consequence at the beginning of the study and immediately and one month after the intervention
Method of measurement
Neffs Self-Compassion Questionnaire

Intervention groups

1

Description
Intervention group: First, all members of the group were contacted one by one, and after coordination and agreement on the timing of the meetings, they were invited to attend on the scheduled date. Compassion therapy sessions were held in 8 one-and-a-half-hour sessions. In the first session, the introduction and identification of each member and the rules of the group were determined, and compassion therapy was explained, and in subsequent sessions, each topic related to compassion was explained. Practice was done in the class and the homework was given for the next session. In the final session, the skills were taught during the previous sessions, and after that, the status of the exercises was followed up by phone within a month.
Category
Behavior

2

Description
2-Control group: Participants were contacted and invited to attend the center, then the questionnaire was completed by the participant and the researcher. During the training sessions for the intervention group, the control group received their routine intervention. At the end of the study, a short session of compassion therapy was performed for this group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine and Metabolism Research Center of Isfahan
Full name of responsible person
Marzieh Najafi
Street address
Tehran Gate, Khoram St., Sedigheh Tahereh Endocrine and Metabolism Research Center
City
Esfahan
Province
Isfehan
Postal code
8193769886
Phone
+98 31 3337 7664
Email
ma.na6144@gmail.com
Web page address
https://emrc.mui.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shagayeg Hagjoo Javanmard
Street address
Shiraz Gate, Hezar Jerib St., Isfahan University of Medical Sciences, Building No. 4
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.mui.ac.ir
Web page address
https://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mousa Alavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib St.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7586
Email
mousa_alavi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mousa Alavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery،University of Medical Sciences, Hezar Jerib St., Shiraz Gate
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7579
Email
mousa_alavi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Marzieh Najafi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 201,26 Alley, Falatoori Ave, Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8193769886
Phone
+98 31 3568 3820
Email
Ma.na6144@mail.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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