The effect of online brief mindfulness-based counseling on infertility related distress in infertile women under treatment: A randomized controlled clinical trial
Determining the effect of abbreviated mindfulness-based counseling on the level of infertility distress in infertile women undergoing treatment: an online intervention.
Design
A clinical trial with a control group, double-blind, randomized, on 70 infertile women under treatment. The rand function of Excel software will be used for randomization.
Settings and conduct
Infertile women will be invited to participate in the research by attending and presenting a written letter of introduction to health centers, clinics, etc. in Mazandaran province. An invitation will also be given on social networks. The possibility of blinding the participants and There is no researcher conducting the intervention during the intervention process, the blinding process will be done by the people who are responsible for collecting information and analyzing data.
Participants/Inclusion and exclusion criteria
Inclusion criteria Iranian nationality, proficiency in the Persian language, having smartphones; And.. Exclusion criteria: intends to use donated embryos, eggs, or surrogates
Intervention groups
The abbreviated awareness course will be held for four group training sessions, each session lasting 2 hours and once a week for 4 weeks. The course will include all the techniques taught in the 8-week course. Less time will be provided to practice each technique in class. After each session, assignments will be given to the participants to practice mindfulness techniques outside the classroom. The supporting materials of the main intervention include a mindfulness manual and forms for exercises. who have noticed and talked about how to find this experience. Each session ends with 3 minutes of breathing exercises
Main outcome variables
Infertility distress، perceived stress،Infertile women's quality of life،laboratory pregnancy testing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160619028528N7
Registration date:2023-02-01, 1401/11/12
Registration timing:prospective
Last update:2023-02-01, 1401/11/12
Update count:0
Registration date
2023-02-01, 1401/11/12
Registrant information
Name
Zeinab Hamzehgardeshi
Name of organization / entity
Mazandaran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.hamzehgardeshi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-14, 1401/11/25
Expected recruitment end date
2023-03-01, 1401/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of online brief mindfulness-based counseling on infertility related distress in infertile women under treatment: A randomized controlled clinical trial
Public title
The effect of online brief mindfulness-based counseling on infertility related distress in infertile women under treatment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality
Proficiency in Persian language
Having smartphones and being able to use them
Women less than 45 years old
Diagnosed infertility
Women treated with assisted reproductive methods (IVF.IUI)
(Anti Mullerian Hormone (AMH)more than 5/ng/mL
Exclusion criteria:
- Intention to use donated embryos, eggs or surrogates
Cancellation of the treatment plan for any reason by the doctor
People who are under the advice of a psychologist or psychiatrist at the time of the study or at least one month before the start of the study
People with major psychiatric disorders at the time of study
Suffering from systemic diseases such as diabetes, high blood pressure, hyperlipidemia, and thyroid gland disease; Based on treatment history, file information, and research unit report.
Based on the treatment history, file information, and research unit report.
Death of a relative or an unfortunate accident at least 3 months before the start of the intervention
Occurrence of pregnancy detected by blood test during the study
Psychiatric drug use (self-report)
Stepchild
Use of cigarettes, hookahs and alcoholic beverages
People with a history of previous marriages - people who were eligible to receive or needed to be prescribed any psychotropic medication or psychotherapy counseling during the study.
Age
To 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked random allocation methods will randomly assign the samples to two intervention groups (awareness attention) and a control group (routine care). This method is usually used in order to balance the number of samples allocated to each of the studied groups. This feature helps the researcher to have the same number of samples allocated to the intervention and control groups of the study in cases where intermediate analysis is needed during the implementation of the sampling process. For this purpose, blocks of four will be considered. The six blocks may be TTCC, CTTC, CTCT, CCTT, TCTC, and TCCT, where T is for the intervention group and C is for the control group. The rand between functions in Excel will be used to select the blocks randomly. The production numbers will be between 1 and 6 and based on the production number of the desired block, all 4 samples will be assigned to the intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the nature of the intervention, it will not be possible to blind the participants and the researcher responsible for the intervention during the intervention process, therefore, in order to control the bias of blinding at the level of the evaluator (evaluator bias), the process of blinding will be carried out in the people who are responsible for collecting information and analyzing data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences ,Moalem Square, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
48178-57344
Approval date
2022-10-11, 1401/07/19
Ethics committee reference number
IR.MAZUMS.REC.1401.332
Health conditions studied
1
Description of health condition studied
Distress of infertile women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Secondary outcome:Improving quality of life
Timepoint
Before intervention ،immediately after the intervention ،one month after the completion of the intervention in the intervention groups (recipient of online counseling and control)
Method of measurement
Infertile women's quality of life questionnaire.
2
Description
perceived stress
Timepoint
Before intervention ،immediately after the intervention ،one month after the completion of the intervention in the intervention groups (recipient of online counseling and control)
Method of measurement
Newton's infertility stress questionnaire
3
Description
laboratory pregnancy testing
Timepoint
Before intervention ،immediately after the intervention ،one month after the completion of the intervention in the intervention groups (recipient of online counseling and control)
Method of measurement
blood test
Secondary outcomes
1
Description
perceived stress of infertile women
Timepoint
Before, immediately after the intervention, and one month after the completion of the intervention in the intervention groups (recipient of online counseling and control
Method of measurement
Newton's infertility stress questionnaire,
2
Description
quality of life score of infertile women
Timepoint
Before, immediately after the intervention, and one month after the completion of the intervention in the intervention groups (recipient of online counseling and control
Method of measurement
Infertile women's quality of life questionnaire.
3
Description
laboratory pregnancy testing
Timepoint
Before intervention ،immediately after the intervention ،one month after the completion of the intervention in the intervention groups (recipient of online counseling and control)
Method of measurement
blood test
Intervention groups
1
Description
The abbreviated awareness course for four group training sessions, each group of seven people will hold 2 hours each session and once a week for 4 weeks. This course will include all the techniques taught in the 8-week course including: mindful breathing, body scanning, guided imagery, kindness, mindful eating, mindful walking or other movements, mindful conversations, and observing one's emotions. Mindful walking or other movements will be used in place of the yoga used during the 8-week course to vary the movements for each person depending on their physical ability (such as sitting in a chair). In order to adapt the content of the required sessions that is shortened in this intervention, the researcher will change the regular education by introducing more than one topic in each class, and also a shorter period of time will be allocated for each topic (about 45 minutes) and less time for Practice of each technique will be provided in class. After each session, participants will be given assignments to practice mindfulness techniques for 20 to 30 minutes outside of class. It is believed that home practice less than 2 days per week is not sufficient and that participants who are more engaged in the session spend more time practicing home skills and are therefore likely to experience better outcomes.Supportive items of the main intervention include a mindfulness manual. Various topics include mindfulness meditation instructions, definition of mindfulness, the importance of being present in the present moment, progress notes and forms for exercises. The first half hour is dedicated to formal mindfulness exercises. Then the participants talk about their feelings, what they noticed and how they found this experience. Each session ends with 3 minutes of breathing exercises.
Category
Behavior
2
Description
Control group:The control group receives routine care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
After obtaining the approval of the Ethics Committee of Mazandaran University of Medical Sciences, r
Full name of responsible person
Zeinab Hamzehgardeshi
Street address
Vesal street
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Fax
+98 11 3336 8915
Email
Z.hamzehgardeshi@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
دکتر مجید سعیدی
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moalem Square, Sari, Mazandaran, Iran.
City
Sari
Province
Mazandaran
Postal code
48431-63181
Phone
+98 11 4443 4210
Email
Majsaeedi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Negin Salarian
Position
Student (MSc)
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Royan.Shohada Street.Kalej 5
City
Noor
Province
Mazandaran
Postal code
4656184933
Phone
+98 11 4451 7185
Email
N.Salarian@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Zeinab Hamzehgardeshi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nasibeh Nursing and Midwifery Faculty, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
48431-63181
Phone
009833367342
Fax
+98 11 3337 8915
Email
z.hamzehgardeshi@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Negin Salarian
Position
Student (MSc)
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Royan.shohada street,kalej 5
City
Noor
Province
Mazandaran
Postal code
4656184933
Phone
+98 11 4451 7185
Email
N.salarian@mazums.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