Protocol summary
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Study aim
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To assess the effect of mindfulness counseling versus control group on the stress of infertile couples undergoing In-vitro fertilizations treatment
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Design
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This is a Phase III randomized clinical trial through the block randomization with a control group with parallel groups, in which 80 eligible patients will be randomly assigned to the intervention and control groups using block randomization.
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Settings and conduct
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This study will be conducted at the Fatemieh hospital in Hamadan city, involving 80 eligible infertile couples undergoing IVF treatment. The patients will be randomly assigned to the intervention and control groups through the block randomization. However, it should be noted that blinding is not feasible in this trial.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age 18 to 45 years;
Primary infertility;
Obtaining a score of at least 93 from Newton's Infertility Stress Questionnaire;
Being literate;
Exclusion criteria:
Admission to the psychiatric ward
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Intervention groups
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Intervention group:
Routine training plus mindfulness counseling for 90 minutes three times a week for 8 weeks
Control group:
Only routine training
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Main outcome variables
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Primary outcome:
The average stress score
General information
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Reason for update
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A very slight change has occurred in the target population and that change is that in this study not only infertile women but also their spouses are examined. Therefore, the word "women" was changed to "couples".
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120215009014N510
Registration date:
2024-05-05, 1403/02/16
Registration timing:
prospective
Last update:
2024-06-14, 1403/03/25
Update count:
1
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Registration date
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2024-05-05, 1403/02/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-05-21, 1403/03/01
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Expected recruitment end date
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2024-09-22, 1403/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of mindfulness counseling versus control group on the stress of infertile couples undergoing In-vitro fertilizations treatment: a randomized clinical trial
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Public title
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Effect of mindfulness counseling versus control group on the stress of infertile couples undergoing In-vitro fertilization's treatment
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 18 to 45 years
Primary infertility
Obtaining a score of at least 93 from Newton's Infertility Stress Questionnaire
Being literate
Exclusion criteria:
Admission to the psychiatric ward
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Age
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From 18 years old to 45 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Factorial
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-04-20, 1403/02/01
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Ethics committee reference number
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IR.UMSHA.REC.1403.029
Health conditions studied
1
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Description of health condition studied
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Stress
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ICD-10 code
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F43.0
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ICD-10 code description
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Acute stress reaction
Primary outcomes
1
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Description
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The average stress score
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Timepoint
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Before the intervention and then after the intervention and just before the in vitro fertilization treatment
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Method of measurement
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Using Newton's infertility stress questionnaire
Intervention groups
1
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Description
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Intervention group: Routine training plus mindfulness counseling for 90 minutes three times a week for 8 weeks (including presence of mind; body inspection meditation; breathing with meditating the mind; stretching movements and breathing with the presence of mind; seeing and hearing with mindfulness; walking with the presence of mind; breath and body awareness meditation; how to react to thoughts and feelings; designing problems and discovering their effects on the body and mind; and awareness of sounds, thoughts and emotions)
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Category
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Other
2
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Description
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Control group: Only routine training
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available