1. Home
  2. Approved trials
  3. » فارسی

Design, implementation, and evaluation of the efficacy of web-based services for a virtual sexual health clinic on sexual dysfunction and enhancement of the sexual quality of life for couples: A randomized controlled clinical trial

Protocol summary

Study aim
Design, implementation, and evaluation of the efficacy of web-based services for a virtual sexual health clinic on sexual dysfunction and enhancement of the sexual quality of life for couples
Design
The clinical trial with a control group will be conducted on 80 samples in parallel groups, randomized, and single-blinded. The random allocation to groups will be generated through the sealdenvelope website random blocks. ________________________________________
Settings and conduct
The sampling will take place at healthcare centers. Women with a Sexual Function Index score (FSFI) of less than or equal to 26.55 and men with a score between 15 and 50 on the International Index of Erectile Function (IIEF) questionnaire will be included in the study. Blinding will be performed at the analysis level of the study.
Participants/Inclusion and exclusion criteria
The presence of sexual dysfunction in one or both partners, married in reproductive ages, owning a computer and smartphone, living with their spouse, excluding criteria: chronic disabling diseases and mental disorders.
Intervention groups
The intervention group will receive counseling through the website once a week for one month (at least 4 sessions, each lasting 60-90 minutes). Counseling will be provided individually based on the Plissit model. The researcher will then send messages to the participants through the virtual network and answer their questions. The control group will receive one counseling session after the intervention is completed, and their questions will be answered. Both groups will complete questionnaires before, immediately after, and one month after the intervention.
Main outcome variables
Quality of life in men's sexual health, quality of life in women's sexual health, sexual function in women, sexual function in men.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110827007422N5
Registration date: 2024-07-15, 1403/04/25
Registration timing: prospective

Last update: 2024-07-15, 1403/04/25
Update count: 0
Registration date
2024-07-15, 1403/04/25
Registrant information
Name
Zhila Ganji
Name of organization / entity
Mazandaran University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
zhila.ganji@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-17, 1403/05/27
Expected recruitment end date
2024-12-07, 1403/09/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation, and evaluation of the efficacy of web-based services for a virtual sexual health clinic on sexual dysfunction and enhancement of the sexual quality of life for couples: A randomized controlled clinical trial
Public title
Efficacy of a web-based virtual clinic in the treatment of sexual dysfunction and the enhancement of the sexual quality of life for couples.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Presence of sexual dysfunction in one or both partners Access to the internet, smartphone, and computer Ability to navigate websites Living with one's spouse Absence of psychological disorders No use of neurologic or psychiatric medications Absence of other chronic physical illnesses At least one year since their marriage Age between 18 to 49 years Married and sexually active Couples without any other temporary partners
Exclusion criteria:
Participation in educational and counseling sessions related to improving sexual performance during the past 6 months Pregnancy or breastfeeding Infertility Participation in other psychological interventions after entering the study Absence of more than 1 session in counseling meetings Scoring 23 or higher on the Goldberg General Health Questionnaire
Age
From 18 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining informed consent, the random allocation of samples will be performed using the Sealedenvelope website based on the required sample size. The samples will be assigned in mixed blocks of two and four to two groups, A and B (intervention and control), in a 1:1 ratio. The letters obtained from the website will be placed in envelopes sequentially numbered from 1 onwards, ensuring the contents are not visible. Each envelope will be labeled with its corresponding number. Participants meeting the inclusion criteria will take an envelope in the order of their arrival and will be directed to the assigned group (A or B) upon opening the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a single-blind study in which the statistical analyst is unaware of the group assignments. The researcher (statistical consultant) who will conduct the data analysis has no information about the status of the samples because the questionnaires have been coded by the researcher who conducted the sampling and intervention. Therefore, the evaluator has no knowledge of which participant was placed in the control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vakilabad Blvd, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Approval date
2024-02-06, 1402/11/17
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.112

Health conditions studied

1

Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction

Primary outcomes

1

Description
Sexual dysfunction
Timepoint
Before the intervention, Immediately After the Intervention, one Month After the Intervention
Method of measurement
The Female Sexual Function Index (FSFI)-The International Index of Erectile Function (IIEF)

2

Description
Quality of sexual life
Timepoint
Before the intervention, Immediately After the Intervention, one Month After the Intervention
Method of measurement
The sexual quality of life-female (SQOL-F) questionnaire-Sexual Quality of Life - Men,(SQOL-M)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: In this study, the intervention group will receive counseling through a website once a week for a minimum of 60-90 minutes using the Plissit model for one month. The questionnaires will be completed immediately and one month later. Access to the questionnaires will be online. The researcher will answer participants' questions and communicate with them through a virtual network. The details of the online sessions are as follows:First Session: Explanation of counseling session details, explanation of its goals by the counselor, introduction of participants to the Plissit model at the basic level, participants express their sexual issues and problems.Second Session: Explanation of the four-step sexual response cycle and the physical and psychological differences between men and women in each stage of the sexual cycle, counselor's responses to potential questions from participants based on the Plissit model. Summary of the counseling session and scheduling of the next session.Third Session: Presentation of personalized recommendations during this period related to the client's issue, recommendations include suggestions for using lubricants, sensory focus exercises, Kegel exercises, and introducing specific positions for intimacy. Summary of the counseling session and scheduling of the next session.Fourth Session: Evaluation of client satisfaction and overall summary of the counseling process, referral for specialized treatment if needed for individuals requiring further intervention.
Category
Treatment - Other

2

Description
Control group: The control group will receive a 60-90 minute counseling session through the website after completing the intervention. And their questions will be answered. In this session, the importance of sexual health, sexual response cycle and physical and mental differences between men and women will be explained.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad health centers
Full name of responsible person
Jila ganji
Street address
Wasal Ave., Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3325 7230
Email
zhila.ganji@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Qureshi Building., Doctor Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3845 2475
Email
Ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Jila Ganji
Position
Assitant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Wasal Ave., Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3325 7230
Email
zhila.ganji@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr khadijah Mirzaiinajamabadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bahonar Ave., Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3845 2475
Email
k.mirzaii@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Jila Ganji
Position
Asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Wasal Ave., Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3325 7230
Email
zhila.ganji@yahoo.com

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
Loading...