To assess the effect of progressive muscle relaxation versus control group on the quality of sleep and anger control in addicted men
Design
This is a Phase III randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using drawing of lots.
Settings and conduct
This study will be conducted at the Narcotics Anonymous Association of Nahavand city, involving 60 eligible addicted men. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. However, it should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Addicted men
He has passed the detoxification course
Being literate
Exclusion criteria:
Mental disorder
Intervention groups
Intervention group:
Routine treatment plus in addition to training in progressive muscle relaxation for 45 minutes twice a week for 4 weeks
Control group:
Just routine treatment
Main outcome variables
Primary outcome:
Sleep quality score, anger control score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N502
Registration date:2024-03-12, 1402/12/22
Registration timing:prospective
Last update:2024-03-12, 1402/12/22
Update count:0
Registration date
2024-03-12, 1402/12/22
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-05-04, 1403/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of progressive muscle relaxation versus control group on the quality of sleep and anger control in addicted men: a randomized clinical trial
Public title
Effect of progressive muscle relaxation versus control group on the quality of sleep and anger control in addicted men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Addicted men
He has passed the detoxification course
Being literate
Exclusion criteria:
Mental disorder
Age
From 18 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to intervention and control groups by lottery. For this purpose, we prepare two sheets, write "intervention" on one and "control" on the other. Then, with each patient's visit, one of the sheets is randomly taken and the patient is assigned to the intervention or control group.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2024-02-24, 1402/12/05
Ethics committee reference number
IR.UMSHA.REC.1402.724
Health conditions studied
1
Description of health condition studied
Sleep disorder
ICD-10 code
F11.282
ICD-10 code description
Opioid dependence with opioid-induced sleep disorder
Primary outcomes
1
Description
Sleep quality score
Timepoint
Before the intervention and 4 and 8 weeks after the intervention
Method of measurement
Using the Pittsburgh Sleep Quality Questionnaire
2
Description
Anger control score
Timepoint
Before the intervention and 4 and 8 weeks after the intervention
Method of measurement
Using the Spielberger Anger Control Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus in addition to training in progressive muscle relaxation for 45 minutes twice a week for 4 weeks including familiarization with addiction and ways to quit it, introduction of muscles and muscle groups involved in progressive muscle relaxation technique, training in progressive muscle relaxation technique, performing progressive muscle relaxation technique under the supervision of the researcher and providing feedback, teaching deep breathing, performing deep breathing under the supervision of the researcher and providing feedback.
Category
Behavior
2
Description
Control group: Just routine treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Narcotics Anonymous Association of Nahavand city
Full name of responsible person
Kamyabfar Alireza
Street address
Narcotics Anonymous Association, at the beginning of Kermanshah Road
City
Nahavand
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
kamyablyrda@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Kamyabfar Alireza
Position
Student of Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
kamyablyrda@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Efat Sadeghi
Position
PhD in Nursery
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sadeghian_e@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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
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
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