Protocol summary

Study aim
Determining and comparing the average mental-behavioral health scores of male and female prisoners in Shahrekord Prison, before and after implementing an environmental design intervention, in the intervention and control groups.
Design
A controlled clinical trial with parallel groups, no blinding, randomized, phase 2, 94 subjects. A random number table will be used for randomization.
Settings and conduct
The study will be conducted using a pre-test-post-test method among prisoners in Shahrekord Central Prison. Participants will be divided into two intervention and control groups, and the evaluation of psychological, behavioral, and prison environmental variables will be conducted using standard and researcher-made questionnaires before and after the implementation of the prison environmental design.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18, ability to answer questions, length of stay in prison equal to the pre-test and post-test periods. Exclusion criteria: Severe mental disorder or documented acute crisis, severe speech/hearing impairment that prevents response, active use of psychotropic substances/medications that interfere with results, very serious crimes with security restrictions.
Intervention groups
Intervention group: Received prison environmental design Control group: Did not receive prison environmental design
Main outcome variables
Average mental health score (depression, anxiety and stress) Average aggression score Average prisoners' environmental perception score Average prison environmental objective assessment score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180722040555N5
Registration date: 2026-02-17, 1404/11/28
Registration timing: prospective

Last update: 2026-02-17, 1404/11/28
Update count: 0
Registration date
2026-02-17, 1404/11/28
Registrant information
Name
Zohreh Karimiankakolaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3336 1047
Email address
zohrehkarimian@ssu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-19, 1405/02/29
Expected recruitment end date
2026-10-21, 1405/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the impact of prison environmental design on prisoners' behavioral mental health and reducing violence-related harms
Public title
Assessing the impact of prison environmental design on prisoners' behavioral mental health and reducing violence-related harms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 Prison stay equal to pre-test and post-test period Ability to respond
Exclusion criteria:
Severe documented psychiatric disorder or acute crisis Severe speech/hearing impairment impeding responsiveness Active use of psychoactive substances/medications interfering with results Very serious crimes with security restrictions
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 94
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, due to the nature of the intervention (environmental design at the level of physical spaces), the randomization unit at the prison ward level will be considered as a cluster. In order to control the effect of potential confounding variables such as [e.g., ward population density, security or semi-security status of the ward], the existing wards will first be stratified (classified) based on these variables. Then, in each stratum, the wards will be randomly assigned to two intervention groups (recipients of the new environmental design) and control (with usual environmental conditions) using a random number table. To comply with the principle of allocation concealment, the randomization sequence will be prepared by someone outside the implementation team and kept in sealed, opaque envelopes to avoid bias in ward selection. Also, to reduce bias in the evaluation of the results, the evaluators of mental health and behavioral outcomes will be unaware of the ward allocation status (intervention or control).
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
Ethics Committee of Islamic Azad University, Shaherekord Branch
Street address
University Street, Islamic Azad University of Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881373339
Approval date
2026-01-14, 1404/10/24
Ethics committee reference number
IR.IAU.SHK.REC.1404.331

Health conditions studied

1

Description of health condition studied
Behavioral mental health
ICD-10 code
Z65
ICD-10 code description
Problems related to other psychosocial circumstances

Primary outcomes

1

Description
Mean score mental health (depression, anxiety, stress)
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Mental Health Questionnaire (DASS-21)

Secondary outcomes

1

Description
Mean score of aggression
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Bass and Perry Aggression Questionnaire (AQ)

2

Description
Mean score of Prisoners’ Environmental Perception
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Prisoners’ Environmental Perception Questionnaire

3

Description
Mean of score Objective Correctional Environment
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Objective Correctional Environment Checklist

Intervention groups

1

Description
In the intervention group, prisoners residing in wards that are subject to the environmental design package will receive a 4-week intervention. The package will be designed and validated by a multidisciplinary team (architect, psychologist, social worker, and health) based on pre-test findings and valid scientific evidence. Interventions include optimizing lighting using warm white light to regulate circadian rhythms, painting spaces with calming blue and green colors to reduce irritability, creating green corners with natural plants or nature images to connect with the natural environment, improving the meeting room to reduce stress and improve emotional connection with the family, and organizing common spaces with standard shelving to reduce visual clutter. All changes will be implemented in coordination with prison authorities and in full compliance with security considerations.
Category
Behavior

2

Description
Control group: No environmental design intervention is implemented in this group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord Central Prison
Full name of responsible person
Mojtaba Khoram
Street address
Shariati Street, Chaharmahal and Bakhtiari Province Prisons Organization
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817613565
Phone
+98 38 3224 3191
Email
mojtabakhorram60@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Chaharmahal and Bakhtiari Province Prisons Organization
Full name of responsible person
Mojtaba Khoram
Street address
Shariati Street, Chaharmahal and Bakhtiari Province Prisons Organization
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817613565
Phone
+98 910 383 2248
Email
mojtabakhorram60@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chaharmahal and Bakhtiari Province Prisons Organization
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zohreh Karimiankakolaki
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
University Street, Islamic Azad University, Shahrekord Branch
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1000
Email
zohrehkarimian68@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zohreh Karimiankakolaki
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
University Street, Islamic Azad University, Shahrekord Branch
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1000
Email
zohrehkarimian68@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zohreh Karimiankakolaki
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
University Street, Islamic Azad University, Shahrekord Branch
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1000
Email
zohrehkarimian68@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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Some data, such as information related to the main outcome or the like, can be shared after being de-identified.
When the data will become available and for how long
Access period starts 6 months after results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Non-personally identifiable data from this study will be made available to researchers solely for the purpose of conducting advanced statistical analyses, including secondary analyses, combined analyses with other studies, and complementary analyses with more advanced methods. Applicants for data and documentation must be qualified researchers (faculty members, postdoctoral researchers, or graduate students) from accredited academic or research institutions and must submit their application along with a written research proposal that has been approved by the ethics committee of the applicant institution. Acceptance and signing of a confidentiality and data use agreement is mandatory, according to which applicants undertake to use the data only for approved research purposes, refrain from any attempt to re-identify individuals, not provide the data to third parties, and provide the final results to the main research team. The use of documentation such as questionnaires and intervention protocols is permitted solely for research and educational purposes and any commercial use is prohibited. In all publications based on this data, it is mandatory to cite the original source and reference the basic study.
From where data/document is obtainable
Principal Investigator Zohreh Karimiankakolaki Zohrehkarimian68@gmail.com
What processes are involved for a request to access data/document
Send an email to the principal investigator stating the reasons and conditions and respond within one working week.
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