Explaining the affectability of the designed integrated therapeutic on couples' interactions and sexual desire with the control group
Design
This study was a clinical trial with simple random allocation, which will be done using a pre-test, post-test, and control group and it was done in parallel. The sample size was 13 pairs in each group. A table of random numbers was used to randomize the samples.
Settings and conduct
ُSampling was performed in the mental health department of Ibn Sina Health Center in Isfahan, the Behavior Therapy Clinic of Khorshid Hospital in Isfahan, and the Preventive Medicine and Health Promotion Behsa Clinic in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Couples with sexual desire deficiency disorder. Exclusion criteria: Chronic physical or psychological diseases; Taking hormonal drugs and drugs that affect sexual function; History of substance abuse or physical aggression; Participation in Couples Therapy and Sex Therapy classes before entering the study; History of infertility; Pregnancy
Intervention groups
For the experimental group, integrated therapy intervention will be designed and for the control group, Sex Therapy with the approach of Masters and Johnson will be performed for ten sessions one meeting a week. Standard questionnaires will be completed before and immediately after the ten sessions of the intervention. Also, to evaluate the long term effects of the therapeutic intervention 8 weeks after the intervention, the questionnaires will be completed again by the participants
Main outcome variables
Marital Satisfaction; Sexual Knowledge and Attitude; Marital Adjustment; Intimacy Needs; Spouses Sexual Disclosure; Female Sexual Function; Male Sexual Function; Female Sexual Desire and Male Sexual Desire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029255N11
Registration date:2021-01-12, 1399/10/23
Registration timing:retrospective
Last update:2021-01-12, 1399/10/23
Update count:0
Registration date
2021-01-12, 1399/10/23
Registrant information
Name
Raziyeh Maasoumi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4214
Email address
r_masoumi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-04-04, 1396/01/15
Actual recruitment end date
2018-03-20, 1396/12/29
Trial completion date
2018-03-20, 1396/12/29
Scientific title
The Effect of Integrative Therapy of Emotional-Focused Couple Therapy and Sex Therapy Masters and Johnson on Couples' Interactions and Sexual Desire
Public title
The Effect of Integrated Therapy on Couples' Sexual Interactions and Desire
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
18-55 years old for men
18 years old until premenopausal for women
Having criteria (SIAD) for women and (HSDD) for men according to DSM-V criteria
Moderate and lower sexual desire by the Halbert Questionnaire for men (score 50 and below)
Moderate or less sexual desire or arousal by the Female Sexual Function Index (score less than 3.4 for sexual arousal or score less than 3.3 for libido, or both)
Interested in attending therapy sessions
At least one year of living together as a permanent marriage
Ability to write and read
Couple age difference less than or equal to 10 years
Duration of marriage between one to 30 years
6 months since the last pregnancy
Exclusion criteria:
History of acute and chronic physical illness
Major psychiatric or psychological illnesses that interfere with treatment
Using drugs that affect sexual function
History of substance abuse or physical aggression
Attending Emotional Focused Therapy for couples or Masters and Johnson sex therapy before studying
History of infertility
Using oral contraception pills
Pregnancy
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be conducted by Simple random allocation. After identification of couples who have eligible to enter thee study, each person will select one card among cards which including A or B character. In person select a cord with A character it means she/he will be included to the intervention group and if the card with B character be selected the person will be included to the control group. this process will be continue to all of sample classified in two groups.
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street, Azadi Squre
City
Isfahan
Province
Isfehan
Postal code
8174673465
Approval date
2015-05-25, 1394/03/04
Ethics committee reference number
IR.MUI.REC.1394.3.488
Health conditions studied
1
Description of health condition studied
Marital Satisfaction
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Sexual Knowledge and Attitude
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Marital Adjustment
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Intimacy
ICD-10 code
ICD-10 code description
5
Description of health condition studied
Sexual Disclosure
ICD-10 code
ICD-10 code description
6
Description of health condition studied
Female Sexual Function
ICD-10 code
ICD-10 code description
7
Description of health condition studied
Male Sexual function
ICD-10 code
ICD-10 code description
8
Description of health condition studied
Female Sexual Desire
ICD-10 code
ICD-10 code description
9
Description of health condition studied
Male Sexual Desire
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Marital Satisfaction of Couples
Timepoint
Before the intervention, immediately and 8 weeks after the intervention
Method of measurement
ENRICH Marital Satisfaction Scale
2
Description
Sexual Knowledge and Attitude of Couples
Timepoint
Before the intervention, immediately and 8 weeks after the intervention
Method of measurement
Sexual Knowledge and Attitude Scale (SKAS)
3
Description
Marital Adjustment of Couples
Timepoint
Before the intervention, immediately and 8 weeks after the intervention
Method of measurement
Dyadic Adjustment Scale (DAS)
4
Description
Marital Intimacy of Couples
Timepoint
Before the intervention, immediately and 8 weeks after the intervention
Method of measurement
Marital Intimacy Needs Questionnaire
5
Description
Spouses Sexual Disclosure
Timepoint
Before the intervention, immediately and 8 weeks after the intervention
Method of measurement
Spouses Sexual Disclosure Scale
6
Description
Female Sexual Function
Timepoint
Before the intervention, immediately and 8 weeks after the intervention
Method of measurement
Female Sexual Function Index (FSFI)
7
Description
Male Sexual Function
Timepoint
Before the intervention, immediately and 8 weeks after the intervention
Method of measurement
International Index of Erectile Function (IIEF)
8
Description
Female Sexual Desire
Timepoint
Before the intervention, immediately and 8 weeks after the intervention
Method of measurement
Female Sexual Function Index (FSFI)
9
Description
Male Sexual Desire
Timepoint
Before the intervention, immediately and 8 weeks after the intervention
Method of measurement
Hurlbert Index of Sexual Desire (HISD)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the experimental group, integration of Masters and Johnson Sex Therapy and Emotional Focused Therapy for Couples treatments were held for 10 sessions. Treatment was performed separately for each couple once a week. Standard questionnaires were completed before and after 10 sessions of intervention and also to evaluate the long-term effects of treatment, 8 weeks after the intervention.
Category
Treatment - Other
2
Description
Control group: For the control group, Masters and Johnson Sex Therapy treatment was held for 10 sessions. Treatment was performed separately for each couple once a week. Standard questionnaires were completed before and after 10 sessions of intervention and also to evaluate the long-term effects of treatment, 8 weeks after the intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Navaab Safavi Healthcare Center of Isfahan
Full name of responsible person
Dr. Raziyeh Maasoumi
Street address
Navab Safavi Healthcare Center, Ahmadabad Square, Bozorgmehr St.
City
تهران
Province
Isfehan
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
2
Recruitment center
Name of recruitment center
Behsa clinic
Full name of responsible person
Dr. Raziyeh Maasoumi
Street address
No.4, Saeb Tabrizi West St., North Sheikh Baha'i St., Mulla Sadra St.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjooye Javanmard
Street address
Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Raziyeh Maasoumi
Position
Pos.doc of Sexology, PhD of Reproductive Health, Assisstent Professor of Reproductive Health Departm
Latest degree
Ph.D.
Other areas of specialty/work
Sexual Health
Street address
Faculty of Nursing and Midwifery, Mirkhani Ave, Tohid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Fax
Email
r_masoumi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Raziyeh Maasoumi
Position
Pos.doc of Sexology, PhD of Reproductive Health, Assisstent Professor of Reproductive Health Departm
Latest degree
Ph.D.
Other areas of specialty/work
Sexual Health
Street address
Faculty of Nursing and Midwifery, Mirkhani Ave, Tohid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Fax
Email
r_masoumi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Raziyeh Maasoumi
Position
Pos.doc of Sexology, PhD of Reproductive Health, Assisstent Professor of Reproductive Health Departm
Latest degree
Ph.D.
Other areas of specialty/work
Sexual Health
Street address
Faculty of Nursing and Midwifery, Mirkhani Ave, Tohid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Fax
Email
r_masoumi@sina.tums.ac.ir
Web page address
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data of the study would be available after the unrecognizable process of participants.
When the data will become available and for how long
6 months after publications of findings
To whom data/document is available
Data of this research would be available for academic researchers.
Under which criteria data/document could be used
Data of this study would be available for same research.
From where data/document is obtainable
Dr. Raziyeh Maasoumi email: r_masoumi@sina.tums.ac.ir
What processes are involved for a request to access data/document
Sending a request by email attendance to the office of corresponding of project presentation the reasons for similarity of two projects studying the proposal by corresponding of project final decision making with corresponding author access of data in office of corresponding author