The effect of stress-based mindfulness group counseling on sexual satisfaction of pregnant women
Design
Clinical trial with control group, with parallel, randomized groups, on 60 patients. Lottery was used for randomization.
Settings and conduct
This is a quasi-experimental controlled study with a pre-test-post-test design that will be performed on 60 pregnant women with a gestational age of 26-20 weeks, referring to Health Center No. 1 in Mashhad. From this center, two comprehensive health service centers will be selected from the total of comprehensive health centers covered by it. The two centers will be allocated to intervention (mindfulness counseling) and control by lottery. . Available sampling is available among eligible women and then randomly assigned to two groups of 30 intervention and control
Participants/Inclusion and exclusion criteria
Pregnant women 20-26 weeks with a score of less than 100 in the sssw sexual satisfaction questionnaire (low and medium). Exclusion criteria: Incidence of medical and midwifery problems, mental illness during the research
Intervention groups
Intervention 1: Pregnant women with sexual satisfaction less than 100 in the sssw questionnaire for whom mindfulness counseling based on stress reduction will be performed. Intervention 2: Pregnant women with sexual satisfaction less than 100 in the sssw questionnaire which is a control group and consultation for They do not take place and only receive routine pregnancy care.
Main outcome variables
sexual satisfaction of pregnant women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200411047037N1
Registration date:2021-06-05, 1400/03/15
Registration timing:prospective
Last update:2021-06-05, 1400/03/15
Update count:0
Registration date
2021-06-05, 1400/03/15
Registrant information
Name
maryam najiabhary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3867 8250
Email address
najiam982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of stress-based group mindfulness counseling on sexual satisfaction of pregnant women
Public title
The effect of mindfulness on sexual satisfaction of pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 20 to 26 weeks without anomaly
No history of problems in previous pregnancies
No medical and midwifery problems
Be literate using a smartphone And Internet access
Score less than 60 for the total score on the DASS-21 questionnaire
Score less than 100 in the sssw sexual satisfaction questionnaire (low and medium)
Being the only wife of the husband
Pregnant and congenital twin pregnancy and no abnormalities
Sexual intercourse at least once a week
Failure to participate in mindfulness courses
No underlying mental illness
No major accident occurred during the previous six months
No history of sexual disorders of a pregnant woman and her husband
Exclusion criteria:
Reluctance to continue attending meetings
Mental illness during research
Incidence of accidents during the study
Incomplete completion of questionnaires (answering less than 10% of the questionnaires)
Having midwifery and medical problems during the research
Do not attend more than one session of counseling
Incidence of accidents during the study
Failure to perform the tasks assigned to mindfulness (by the researcher) by 10%
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
From the center number 1 of Mashhad, two comprehensive health service centers will be selected from the total of comprehensive health centers covered by it. The two centers will be allocated to intervention (mindfulness counseling) and control by lottery. . Available sampling is available among eligible women and then randomly assigned to two groups of 30 intervention and control
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
Working Group / Ethics Committee in Research, School of Nursing and Midwifery, Mashhad University of
Street address
Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-05-18, 1400/02/28
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.015
Health conditions studied
1
Description of health condition studied
Sexual satisfaction of pregnant mothers
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder
Primary outcomes
1
Description
Sexual Satisfaction: The meaning of sexual satisfaction in this study is the score obtained from the sssw Sexual Satisfaction Questionnaire, which has 30 questions and consists of 5 subscales. Each subscale consists of 6 questions. The 5 subscales of this questionnaire are: Satisfaction, Communication, adjustment, relationship anxiety, personal anxiety. In this questionnaire, a higher score indicates higher sexual satisfaction and vice versa.
Timepoint
The time periods for measuring sexual satisfaction score are at the beginning of the study and 4 weeks after the end of mindfulness counseling.
Method of measurement
Sexual Satisfaction: The meaning of sexual satisfaction in this study is the score obtained from the sssw Sexual Satisfaction Questionnaire, which has 30 questions and consists of 5 subscales. Each subscale consists of 6 questions. The 5 subscales of this questionnaire are: Satisfaction, Communication, adjustment, relationship anxiety, personal anxiety. In this questionnaire, a higher score indicates higher sexual satisfaction and vice versa.The scoring of the questionnaire is such that questions 1, 4, 5, 6, 9, 10, 11, and 12 are scored in reverse. The scores are obtained after each sum of the questions. The total score is calculated in this way. : (Satisfaction + Communication + Relational Anxiety + Personal Anxiety) / 2. The minimum possible score will be 30 and the maximum will be 150. The score between 30 and 50 is low for female sexual satisfaction. The score between 50 and 100 is moderate for female sexual satisfaction. The score is higher than 100. Women's sexual satisfaction is high.
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, patients with a gestational age of 20 to 26 weeks, in the intervention group, 8 sessions (the first face-to-face session and the next 7 sessions are practically virtual, which is twice a week, each session will last 45 to 60 minutes). Consultation sessions will be held in groups with 10 pregnant mothers in each group. The first session (automatic implementation):Familiarity of group members with each other and greeting, expression of group rules (confidentiality and non-disclosure of participants' personal information, timely attendance of members in meetings, no more than two sessions) Familiarity and general description of the consultation approach and a brief description of 8 sessions Do meditations on eating a raisin and then meditate for 30 minutes meditating on the body and talking about the feelings that come from doing these meditations (getting feedback) - Homework: Applying what they learned when eating a raisin seed about eating or Dishwashing.Second session (removal of obstacles):- Doing meditation, body scan and discussion about this experience - Discussion about homework, barriers to training and mindfulness program solutions for it - Discussion about homework - Doing meditation while sitting - Homework, mindfulness is a pleasant event, Doing sitting meditation and scanning the body and mind is a daily activity, awareness of pleasant events.Session 3 (Mindfulness Breathing):Calm movements and mindfulness of yoga are presented as ways to calm the physical symptoms of stress and become aware of the delicate movements of the body. - Practice seeing and hearing (in this exercise, participants are asked to judge non-judgmentally for 2 minutes). Look and listen - Sitting meditation and breathing according to the physical senses - Assignment: Sitting meditation, body scan, three-minute practice of breathing space, mindfulness of a new daily activity and mindfulness of unpleasant eventsSession 4 (Staying in the moment):- Sitting meditation with emphasis on breathing, body sounds and thoughts - Discussion about stress responses and a person's reaction to difficult situations and alternative attitudes and behaviors - Mindful walking practice - Assignments: sitting meditation, body scan or One of the mind-conscious body movements and three-minute breathing space exercise (in a pleasant event)Session 5 (accepting and allowing):Performing sitting meditation - Presenting and performing mind-conscious body movements - Assignments: Sitting meditation, three-minute breathing space in an unpleasant event and mindfulness of a new activity in daily lifeSession 6 (thoughts do not have a real origin):- Practice three minutes of breathing space - Discuss homework in groups of 10 - Provide an exercise entitled "Creation, thought, separate perspectives" with the theme, the content of thoughts, are often not real - Provide four meditation exercises for one hour Homework - Choosing a combination of meditations that is a personal preference plus doing three minutes of breathing space in a pleasant event and mindfulness of a new daily activity.Session 7 (How to take the best care of yourself):- Meditation and awareness of everything that comes to mind in the moment - The theme of this session is: What is the best way to take care of myself? - Provide an exercise in which participants determine which of their life events are pleasant and which are unpleasant. In addition, how to plan a program that has enough pleasant events - three minutes of breathing space - Assignments: Do a combination of meditation that is preferred for the person, three minutes of breathing practice in a pleasant event. Genitourinary and musculoskeletal changes, expression of physical and psychological changes in pregnancySession 8 (How to use these in future decisions):-Scan - The theme of this session is: Use what they have learned so far - Practice three minutes of breathing space - Discuss ways to cope with the obstacles of meditation - Express emotional and psychological changes Anxiety and fear and depression - Ask questions in The whole case of meetings and summaries.
Category
Lifestyle
2
Description
Control group: The control group will also receive routine pregnancy care.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad health centers
Full name of responsible person
Maryam Naji Abhary
Street address
Khorasan Razavi, Mashhad, Daneshgah St., Doctra Crossroads, Ibn Sina St.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
najiabhary@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Taqfadi
Street address
University St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
TafaghodiM@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
80
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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Naji Abhary
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mashhad, Ibn Sina St., School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+985138591511-3
Email
najiam982@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahin Tafzali
Position
Faculty of Mashhad School of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashhad, Ibn Sina St., School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
tafazolim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Naji Abhary
Position
Master student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mashhad, Ibn Sina St., School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
najiam@mums.acir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
All data is potentially shareable after identifying individuals
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers and students of academic institutions
Under which criteria data/document could be used
Based on the present study and no change in the data
From where data/document is obtainable
Contact the author responsible for responding via email or phone: najiabhary@gmail.com and phone 00989151253899
What processes are involved for a request to access data/document
The request for access to data / documents will be reviewed by the research team