Determining the effect of mindfulness-based cognitive counseling on sexual distress and quality of sexual life in pregnant women
Design
Clinical trial with pretest- post test design with control groups, single- blind, and randomized with quadruple blocks on 84 pregnant women.
Settings and conduct
The statistical population of the study in this study includes all pregnant women who referred to health centers in Ahvaz who have referred to the mentioned centers to receive prenatal care.
Samples will be selected taking into account the entry and exit criteria.
Samples will be randomly assigned with a block design in two groups of experimental (n = 42) and control (n = 42)
No blindness was observed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Gestational age 20 to 28 weeks
Noulipara
Age range 20 to 35 years
Have a minimum of middle school education
Marital status
A score of 11 or higher on the Sexual Distress Questionnaire
Score below the community average of the Women's Sexual Quality of Life Questionnaire
Exclusion criteria:
Occurrence of an unfortunate event in the last 6 months
Having a specific physical and mental illness
Having midwifery problems
Addiction to alcohol, drugs and other psychotropic drugs
Taking medication (other than during pregnancy)
Intervention groups
The experimental group will receive 8 sessions of mindfulness-based cognitive counseling for 90 minutes, once a week and on a specific day. The control group did not receive any intervention.
Main outcome variables
Quality of women's sexual life; sexual distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200901048581N1
Registration date:2020-09-21, 1399/06/31
Registration timing:registered_while_recruiting
Last update:2020-09-21, 1399/06/31
Update count:0
Registration date
2020-09-21, 1399/06/31
Registrant information
Name
hedye ahmadiyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4358 3660
Email address
ahmadiyan.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-21, 1399/06/31
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based cognitive counseling on the sexual distress and quality of sexual life of pregnant women
Public title
The effect of mindfulness-based cognitive counseling on the sexual distress and quality of sexual life of pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 20 to 28 weeks
Noulipara
Age range 20 to 35 years
Have a minimum of middle school education
Marital status
Ability to have natural sex
A score of 11 or higher on the Sexual Distress Questionnaire
Score below the community average of the Women's Sexual Quality of Life Questionnaire
Exclusion criteria:
Occurrence of an unfortunate event (death of loved ones, accidents with disabilities, etc.) in the last 6 months
Having a specific physical and mental illness
Having midwifery problems
Addiction to alcohol, drugs and other psychotropic drugs
Taking medication (other than during pregnancy)
Having sexual dysfunction in yourself and your spouse before pregnancy
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples to each of the intervention and control groups was performed by block random method using quadruple blocks (By the table for random permutations). Also, opaque envelops which are numbered sequentially, will be used to hide random allocations. Accordingly, the participants will be given codes and assigned in to the intervention and control 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 Ahwaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences, School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-05-01, 1399/02/12
Ethics committee reference number
IR.AJUMS.REC.1399.135
Health conditions studied
1
Description of health condition studied
Sexual distress
ICD-10 code
F52.9
ICD-10 code description
Sexual dysfunction
Primary outcomes
1
Description
The Sexual Quality of Life and sexual distress
Timepoint
Before the intervention and after the intervention
Method of measurement
The Sexual Quality of Life–Female questionnaire and The Female Sexual Distress Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The test group will receive 8 90 minute sessions of group Mindfulness-based cognitive counseling, once a week and on a specific day. The sessions will be conducted by a researcher who has received The necessary training and certification in Mindfulness-based cognitive counseling and the consultant will attened some of the sessions to ensure the correctness of the intervention. Finally, After completion of the sessions post- test will be taken.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
17th Shahrivar Clinic
Full name of responsible person
Hediyeh Ahmadian
Street address
Shahid Gandami St., in front of Hoda Middle School, between Rastegari and Vakili next to Mosalla
City
Ahvaz
Province
Khouzestan
Postal code
6173663369
Phone
+98 61 3334 1021
Email
hedye.ahmadiyan73@gmail.com
2
Recruitment center
Name of recruitment center
Comprehensive Health Service Center No. 19
Full name of responsible person
Mojalal
Street address
Above Pediatric Clinic, Zavieh St.
City
Ahvaz
Province
Khouzestan
Postal code
6164873731
Phone
+98 61 3333 1343
Email
ahmadiyan.h@ajums.ac.ir
3
Recruitment center
Name of recruitment center
Comprehensive Health Center No. 9
Full name of responsible person
Hediyeh Ahmadian
Street address
Amaniyeh, corner of Bahman Street
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3333 1343
Email
ahmadiyan.h@ajums.ac.ir
4
Recruitment center
Name of recruitment center
Comprehensive Health Center No. 4
Full name of responsible person
Hediyeh Ahmadian
Street address
Saadi alley, Bazaarcheh street
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3334 1021
Email
ahmadiyan.h@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mehdi Ahmadi Moghadam
Street address
Golestan Blvd, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357- 15794
Phone
+98 61 3336 2414
Fax
+98 61 3336 2414
Email
iitc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hedye Ahmadiyan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd., School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357- 15794
Phone
+98 61 3336 2414
Fax
+98 61 3336 2414
Email
hedye.ahmadiyan73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mina Iravani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd., School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357- 15794
Phone
+98 61 3336 2414
Fax
+98 61 3336 2414
Email
iravani-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hedye Ahmadiyan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd., School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
31357-15794
Phone
+98 61 3336 2414
Email
hedye.ahmadiyan73@gmail.com
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After unrecognizable the participants, the information of original outcome will be shared.
When the data will become available and for how long
The publication of the information will be possible six months after the publication of the results.
To whom data/document is available
Access to research documentation for research centers and researchers and therapists is possible.
Under which criteria data/document could be used
Data are available with reference to the researcher's name and clinical and research procedures.
From where data/document is obtainable
Ahvaz University of Medical Sciences, School of Nursing and Midwifery, Dr. Mina Irvani, Tel: 00989163222899, Email: iravani-m@ajums.ac.ir, Postal Code: 61357-15794
What processes are involved for a request to access data/document
Following the correspondence with research deputy of Ahvaz University of Medical Sciences, the results will be available to applicants.