Protocol summary

Study aim
Determining the effect of mindfulness intervention based on stress reduction on self-compassion and the quality of parent-child relationships in health caregivers
Design
The educational intervention consisted of eight sessions and was implemented in the form of three training methods (lecture, question and answer, discussion group) in comprehensive health centers for health caregivers of the experimental group. The content of the training was mindfulness and its components for patients in the experimental group.
Settings and conduct
The researcher contacted the comprehensive centers and after providing explanations about the project to the authorities, including security and obtaining permission to carry out the project, the researcher made the necessary arrangements. Then, the researcher visited the comprehensive health centers in Masjed Soleyman city and talked to the female health caregivers and asked them to participate in the project, and the standard questionnaires on stress, self-compassion, and parent-child relationship were completed by the referring person. Next, the researcher randomly selected two centers as the experimental group and provided educational content for them. Then, after two months, she returned to the centers and completed the relevant questionnaires again.
Participants/Inclusion and exclusion criteria
Health Caregivers
Intervention groups
Health Caregivers working in comprehensive health centers in Masjed Soleyman city
Main outcome variables
Depression, stress, anxiety and self-compassion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250323065147N2
Registration date: 2025-09-28, 1404/07/06
Registration timing: retrospective

Last update: 2025-09-28, 1404/07/06
Update count: 0
Registration date
2025-09-28, 1404/07/06
Registrant information
Name
Ali Khani Jeihooni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1001
Email address
alikhanijeihooni@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2025-02-08, 1403/11/20
Actual recruitment start date
2024-04-08, 1403/01/20
Actual recruitment end date
2025-02-08, 1403/11/20
Trial completion date
2025-02-08, 1403/11/20
Scientific title
Investigating the effect of mindfulness intervention based on stress reduction on self-compassion and the quality of parent-child relationships in health caregivers
Public title
Mindfulness intervention based on stress reduction on self-compassion and the quality of parent-child relationships
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Health Caregivers Having children Willingness to participate in the educational group Adequate visual and auditory function No change of residence outside the research environment from the beginning of the study to the end of the study
Exclusion criteria:
Unwillingness to participate in the study Absence of more than two training sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was available but group assignment was random.
Blinding (investigator's opinion)
Single blinded
Blinding description
The subjects were randomly assigned to two groups and initially did not know whether they were in the experimental or control group.
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
Building No. 1, Department of Public Health, School of Health, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Approval date
2024-05-26, 1403/03/06
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1403.026

Health conditions studied

1

Description of health condition studied
Stress
ICD-10 code
Z73.3
ICD-10 code description
Stress, not elsewhere classified

Primary outcomes

1

Description
Stress
Timepoint
Before the intervention and 2 months later
Method of measurement
Questionnaire

2

Description
Self-compassion
Timepoint
Before the intervention and 2 months later
Method of measurement
Questionnaire

3

Description
Parent-child relationship
Timepoint
Before the intervention and 2 months later
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Experimental group: The educational intervention for the experimental group consisted of eight sessions and was implemented in the form of three training methods (lecture, question and answer and discussion group) in comprehensive health centers for caregivers of the experimental group. Then, two months after the educational intervention, the data were completed again and compared with before the educational intervention. The content of the training was mindfulness and its components including establishing communication, building trust, meditation training, creating focus, calming the mind, improving the relationship with God and creating optimism, parent-child relationships, and self-compassion, and finally reviewing the materials.
Category
Lifestyle

2

Description
Control group: No educational intervention was provided for the control group, and only due to ethical considerations, educational content was provided to them at the end of the study.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Health Centers of Masjed Soleyman city
Full name of responsible person
Ali Khani Jeihooni
Street address
Payam Noor University-Bibayan
City
Masjed Soleyman
Province
Khouzestan
Postal code
۶۱۳۵۷۱۵۷۹۴
Phone
+98 917 532 8065
Email
khani_1512@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice President for Research, Shiraz University of Medical Sciences
Full name of responsible person
Ali Khani Jeihooni
Street address
Building No. 1, Department of Public Health, School of Health, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 917 532 8065
Email
khani_1512@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President for Research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ali Khani Jeihooni
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Building No. 1, Department of Public Health, School of Health, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3726 1020
Email
khani_1512@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Khani Jeihooni
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Building No. 1, Department of Public Health, School of Health, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3726 1020
Email
khani_1512@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Khani Jeihooni
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Building No. 1, Department of Public Health, School of Health, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Fax
+98 71 3627 0325
Email
alikhanijeihooni@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Educational content, people information and analyzed data
When the data will become available and for how long
Anytime
To whom data/document is available
According to the request of individuals or organizations
Under which criteria data/document could be used
For scientific use
From where data/document is obtainable
Ali Khani Jeihooni - Shiraz School of Health
What processes are involved for a request to access data/document
Request by phone or email
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