Effect of psychosexual rehabilitation versus control group on sexual quality of life and post-traumatic stress disorder in women with near-death experiences related to pregnancy causes: a randomized clinical trial
To assess the effect of psychosexual rehabilitation versus control group on sexual quality of life and post-traumatic stress disorder in women with near-death experiences related to pregnancy causes
Design
This is a randomized clinical trial with a control group with parallel groups without blinding, in which 48 eligible patients will be randomly assigned to the intervention and control groups by lottery.
Settings and conduct
This study will be conducted at the Kosar Hospital in Urmia, involving 48 eligible women with near-death experiences related to pregnancy causes. The patients will be randomly assigned to the intervention and control groups through the lottery. This trial will not be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 14 to 45 years,
Near-death experiences related to pregnancy causes,
Educated,
Exclusion criteria:
Psychiatric disorders
Intervention groups
Intervention group:
Routine treatment and care for women with near-death experiences related to pregnancy causes plus psychosexual rehabilitation for 60 to 90 minutes, two session per week for 3 weeks
Control group:
Routine treatment and care for women with near-death experiences related to pregnancy causes
Main outcome variables
Primary outcome:
Average quality of sextual life score; Average stress score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N600
Registration date:2026-04-09, 1405/01/20
Registration timing:prospective
Last update:2026-04-09, 1405/01/20
Update count:0
Registration date
2026-04-09, 1405/01/20
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
2026-04-30, 1405/02/10
Expected recruitment end date
2026-08-01, 1405/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of psychosexual rehabilitation versus control group on sexual quality of life and post-traumatic stress disorder in women with near-death experiences related to pregnancy causes: a randomized clinical trial
Public title
Effect of psychosexual rehabilitation versus control group on sexual quality of life and post-traumatic stress disorder in women with near-death experiences related to pregnancy causes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 14 to 45 years,
Near-death experiences related to pregnancy causes,
Educated,
Exclusion criteria:
Psychiatric disorders
Age
From 14 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
48
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 Urmia University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Urmia University of Medical Sciences, Pardis Nazlo Road
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2026-02-18, 1404/11/29
Ethics committee reference number
IR.UMSU.REC.1404.536
Health conditions studied
1
Description of health condition studied
Post-traumatic stress disorder (PTSD)
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
Primary outcomes
1
Description
Average quality of sextual life score
Timepoint
Before intervention and one month later
Method of measurement
Using the sextual quality-of-life questionnaire for women
2
Description
Average stress score
Timepoint
Before intervention and one month later
Method of measurement
Using the post-traumatic stress disorder questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment and care for women with near-death experiences related to pregnancy causes plus psychosexual rehabilitation for 60 to 90 minutes, two session per week for 3 weeks (including familiar with anatomy and physiology of men and women sextual organ, sextual interaction, effect of such experience on sextual quality of life, physical and mental natural response to traumatic experiences, deep respiratory exercises and relaxation of muscles, writing about postpartum emotions, believes, anxiety, thoughts and methods of their prevention, methods of managing relationship and calmness, expression of experiences, agitations and individual sextual problems post traumatic pregnancy, evaluation and detection of individual problems, education of stop thought technique, technique of focusing at the moment, evaluation of fears in performing sextual relationship, technique for self-excitement, technique for stress management, technique for adaptation, technique for sextual focus)
Category
Rehabilitation
2
Description
Control group: Routine treatment and care for women with near-death experiences related to pregnancy causes
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital in Urmia
Full name of responsible person
Sahar Pourzeinal
Street address
Kosar Hospital, Hasani Ave.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 5079
Email
Sahar.pr1370@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Urmia University of Medical Sciences, Pardis Nazlo Road
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
info.research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Sahar Pourzeinal
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Urmia University of Medical Sciences, Pardis Nazlo Road
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
Sahar.pr1370@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Soheila Rabiapoor
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Urmia University of Medical Sciences, Pardis Nazlo Road
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
Soheila80@yahoo.com
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