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The Effect of Transcendental Medicine Educational Intervention (Based on Spiritual Meditation) on Improving Stress, Anxiety, Depression, and Optimism in Women with Spontaneous Abortion Referring to Comprehensive Health Centers

Protocol summary

Study aim
The Effect of Transcendental Medicine Educational Intervention (Based on Spiritual Meditation) on Improving Stress, Anxiety, Depression, and Optimism in Women with Spontaneous Abortion Referring to Comprehensive Health Centers of Shiraz
Design
The educational intervention in this study will be conducted on women with spontaneous abortion in Shiraz in 2026 (50 participants in the Transcendental Medicine-based intervention training group). These sessions will be administered by the researcher and supervised by the thesis supervisor and project advisors. The intervention program will consist of 8 sessions over two months, with two sessions per week, conducted in person.
Settings and conduct
A randomized, two-arm, unblinded (open-label) clinical trial with a control group was conducted on 50 women with spontaneous abortion. A table of random numbers was used for randomization.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study include women aged 20 to 45 years (reproductive age), having experienced at least one spontaneous abortion (at least one within the past 6 months), absence of severe or chronic psychiatric disorders requiring active pharmacological treatment (e.g., schizophrenia or bipolar disorder). The exclusion criteria include experiencing other severe stressful events (e.g., death of close relatives) that could confound the results, and absence from more than two training sessions.
Intervention groups
Eligible participants were allocated into two groups (Transcendental Medicine based on spiritual meditation and control) through simple randomization using a table of random numbers, whereby even numbers were assigned to the intervention group and odd numbers to the control group.
Main outcome variables
mean scores of stress, anxiety, depression, and optimism.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260615069802N2
Registration date: 2026-06-25, 1405/04/04
Registration timing: prospective

Last update: 2026-06-25, 1405/04/04
Update count: 0
Registration date
2026-06-25, 1405/04/04
Registrant information
Name
Samira Taravatmanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 917 7516
Email address
samira.n.s.taravat@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-07-01, 1405/04/10
Expected recruitment end date
2026-09-01, 1405/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Transcendental Medicine Educational Intervention (Based on Spiritual Meditation) on Improving Stress, Anxiety, Depression, and Optimism in Women with Spontaneous Abortion Referring to Comprehensive Health Centers
Public title
The Effect of Transcendental Medicine Educational Intervention (Based on Spiritual Meditation) on Improving Stress, Anxiety, Depression, and Optimism in Women with Spontaneous Abortion
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 20 to 45 years (reproductive age). Having experienced at least one spontaneous abortion (at least one spontaneous abortion within the past 6 months). Absence of severe or chronic psychiatric disorders requiring active pharmacological treatment (e.g., schizophrenia or bipolar disorder). No participation in similar psychological or spiritual meditation interventions within the past 6 months.
Exclusion criteria:
Recent use of psychotropic or antidepressant medications (within the past 3 months). Current pregnancy or active attempts to conceive that would hinder attendance at the sessions. Experiencing other severe stressful events (e.g., death of close relatives) that could confound the results. Absence from more than two training sessions.
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were allocated to the groups through simple randomization using a table of random numbers. To achieve this, the numbers were read from top to bottom, with the predetermined rule that even numbers would be assigned to the intervention group and odd numbers to the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
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
Central Building, Shiraz University of Medical Sciences, Zand St., Opposite Palestine St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2026-03-14, 1404/12/23
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1404.141

Health conditions studied

1

Description of health condition studied
Stress, anxiety, depression, and optimism.
ICD-10 code
No specifi
ICD-10 code description
No specific ICD-10 code

Primary outcomes

1

Description
The mean scores of stress, anxiety, depression, and optimism.
Timepoint
Prior to the start of the educational intervention and two months after the start of the educational intervention.
Method of measurement
Based on the standard DASS-21 (Depression, Anxiety, and Stress Scale) questionnaire and the Scheier and Carver Optimism Questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Women with spontaneous abortion referring to comprehensive health centers of Shiraz in 2026 (50 participants in the Transcendental Medicine-based intervention training group). The intervention will be conducted through a series of sessions, which will be administered by the researcher and supervised by the thesis supervisor and project advisors. The intervention program will consist of the Transcendental Medicine-based intervention, comprising 8 sessions over two months, with two sessions per week, conducted in person.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
مراکز جامعه سلامت شهر شیراز در سال 1405
Full name of responsible person
Samira Taravatmanesh
Street address
Shiraz, Zand Street, Opposite Palestine Street, Central Building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
samira.n.s.taravat@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences
Street address
Central Building, Shiraz University of Medical Sciences, Zand St., Opposite Palestine St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2000
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tayebeh Rakhshani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Central Building, Shiraz University of Medical Sciences, Zand St., Opposite Palestine St., Shiraz, Iran
City
shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2000
Email
trakhshani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Samira Taravatmanesh
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Central Building, Shiraz University of Medical Sciences, Zand St., Opposite Palestine St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
samira.n.s.taravat@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Tayebeh Rakhshani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Central Building, Shiraz University of Medical Sciences, Zand St., Opposite Palestine St., Shiraz, Iran
City
shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2000
Email
trakhshani@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
It will be published as an article titled "The Effect of Transcendental Medicine Educational Intervention (Based on Spiritual Meditation) on Improving Stress, Anxiety, Depression, and Optimism in Women with Spontaneous Abortion Referring to Comprehensive Health Centers of Shiraz in 2025–2026".
When the data will become available and for how long
2026
To whom data/document is available
All People
Under which criteria data/document could be used
For healthcare teams (including physicians, nurses, and social workers) to become familiar with the implementation of this educational intervention.
From where data/document is obtainable
To obtain the document, please refer to the principal investigator of the study, Dr. Tayyebeh Rakhshani.
What processes are involved for a request to access data/document
To obtain information, please refer to the thesis supervisor, Dr. Tayyebeh Rakhshani, or the researcher, Dr. Samira Taravatmanesh.
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