Effect of sexual counseling based on the Good Enough Sex model versus control group on sexual quality of life and satisfaction with appearance in women after burn trauma: a randomized clinical trial
To assess the effect of sexual counseling based on the Good Enough Sex model versus control group on sexual quality of life and satisfaction with appearance in women after burn trauma
Design
This is a randomized clinical trial with a control group with parallel groups without blinding, in which 42 eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Sina Hospital in Tabriz, involving 42 eligible women affected with burn. The patients will be randomly assigned to the intervention and control groups using block randomization. This trial will not be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 49 years,
Whole body burn between 10 to 40 percent,
Married,
Educated,
Exclusion criteria:
Psychiatric disorders
Sexual disorders
Intervention groups
Intervention group:
Routine treatment and care of burn plus sexual counseling based on the Good Enough Sex model for 90 to 120 minutes, one session per week for 4 weeks
Control group:
Routine treatment and care of burn
Main outcome variables
Primary outcome:
Average quality of sextual life score; Average score of satisfaction with appearance; Average score of sexual dysfunctions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N598
Registration date:2026-04-08, 1405/01/19
Registration timing:prospective
Last update:2026-04-08, 1405/01/19
Update count:0
Registration date
2026-04-08, 1405/01/19
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
2026-05-05, 1405/02/15
Expected recruitment end date
2026-08-06, 1405/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sexual counseling based on the Good Enough Sex model versus control group on sexual quality of life and satisfaction with appearance in women after burn trauma: a randomized clinical trial
Public title
Effect of sexual counseling based on the Good Enough Sex model versus control group on sexual quality of life and satisfaction with appearance in women after burn trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 49 years,
Whole body burn between 10 to 40 percent,
Married,
Educated,
Exclusion criteria:
Psychiatric disorders
Sexual disorders
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Routine treatment and care of burn plus sexual counseling based on the Good Enough Sex model for 90 to 120 minutes, one session per week for 4 weeks (including definition of enough not perfect sextual relationship, effect of burn on body, physiologic changes after burn, acceptance of body appearance in sextual satisfaction, methods of self-care after burn, softening scars, safe massage with moistening cream, selecting carefree cloths for positive touching of body, flexibility in sextual experience, relaxation rather than idealism, skills of producing intimacy, reconstruction of body confidence, persistency of good relationship)
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
2026-04-06, 1405/01/17
Ethics committee reference number
IR.UMSU.REC.1405.005
Health conditions studied
1
Description of health condition studied
Whole body burn
ICD-10 code
T30
ICD-10 code description
Burn and corrosion, body region unspecified
Primary outcomes
1
Description
Average quality of sextual life score
Timepoint
Before intervention and one month later
Method of measurement
Using Symonds Sexual Quality-of-Life for Female Questionnaire
2
Description
Average score of satisfaction with appearance
Timepoint
Before intervention and one month later
Method of measurement
Using the Satisfaction with Appearance Scale
3
Description
Average score of sexual dysfunctions
Timepoint
Before intervention and one month later
Method of measurement
Using the Female Sexual Dysfunction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment and care of burn plus sexual counseling based on the Good Enough Sex model for 90 to 120 minutes, one session per week for 4 weeks (including definition of enough not perfect sextual relationship, effect of burn on body, physiologic changes after burn, acceptance of body appearance in sextual satisfaction, methods of self-care after burn, softening scars, safe massage with moistening cream, selecting carefree cloths for positive touching of body, flexibility in sextual experience, relaxation rather than idealism, skills of producing intimacy, reconstruction of body confidence, persistency of good relationship)
Category
Other
2
Description
Control group: Routine treatment and care of burn
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Tabriz
Full name of responsible person
Zeynab Vahidi
Street address
Sina Hospital, Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5714783734
Phone
+98 41 3541 2103
Email
vahidizeynab@yahoo.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
Zeynab Vahidi
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
vahidizeynab@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Samira Barjasteh
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
samira_barjaste_70@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