Protocol summary
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Study aim
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Determining the effectiveness of telephone counseling based on mindfulness on relational concern of infertile women
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Design
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Clinical trial with control group, open label, random assignment in control group and intervention with random blocks of 4 by online randomizer, on 80 participants.
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Settings and conduct
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The first session will be held in person at the Fatima Al-Zahra Infertility Center. Demographic and midwifery and sexual anxiety questionnaires will be completed by the samples as a pre-test. Mindfulness counseling will be conducted in 8 sessions for 8 weeks by the researcher based on the standard Kabat-Zinn protocol, 7 sessions of which will be 30-minute phone calls to the participants. Daily mindfulness exercises are suggested and participants' questions will be answered in between sessions. No intervention will be done for the control group. After a period of 8 weeks, the women's sexual relational concern questionnaire will be completed virtually by all the participants in the two groups. To check the stability of the intervention, in the twelfth week after the start of the study, the samples are again requested to complete the sexual relational concern questionnaire virtually.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: diagnosis of infertility, ability to read and write, having personal mobile phone and age less than 50
Exclusion criteria: non-participation in two training sessions, attendance at other psychological interventions or training sessions, and known psychiatric illness.
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Intervention groups
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In the Intervention group, there will be 8 telephone counseling sessions based on mindfulness along with the pre-test and post-test of the sexual anxiety scale. The control group does not receive any counseling.
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Main outcome variables
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sexual relational concern
General information
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Reason for update
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Dear Recipient,
Please implement the following changes to the research plan, as approved by the Babol University of Medical Sciences Research Council and Ethics Committee:
* Replace "sexual anxiety" with "relational concern" in the title.
* Remove "Babol city" from the title.
* Increase the sample size per group from 30 to 40.
Thank you.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180218038783N8
Registration date:
2024-01-20, 1402/10/30
Registration timing:
prospective
Last update:
2025-04-10, 1404/01/21
Update count:
1
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Registration date
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2024-01-20, 1402/10/30
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2024-01-21, 1402/11/01
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Expected recruitment end date
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2027-01-21, 1405/11/01
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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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Effectiveness of telephone counseling based on mindfulness on relational concern of infertile women
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Public title
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Effectiveness of telephone counseling based on mindfulness on relational concern of infertile women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of infertility
Ability to read and write
Having a personal cell phone
Age less than 50 years
Attending at least 6 mindfulness intervention sessions
Exclusion criteria:
Attending other psychological interventions or training
Having a known psychiatric illness
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Age
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To 50 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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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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Participants (ratio 1:1) will be placed in two training and control groups (group A and B) using the randomization method with random blocks of 4 (produced by online randomizer). In such a way that the researcher cannot predict in which group the next person will be placed. The random allocation list will be solely at the discretion of the study administrator.
The randomization list is taken from the following site:
Sealed Envelope Ltd. 2022. Create a blocked randomization list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 31 Dec 2023].
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, due to the nature of the intervention, it will not be possible to blind the researcher in the first stage. Blinding will only be done for the data analyst
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Placebo
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Not used
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Assignment
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Parallel
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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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2023-11-27, 1402/09/06
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Ethics committee reference number
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IR.MUBABOL.REC.1402.141
Health conditions studied
1
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Description of health condition studied
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infertility
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ICD-10 code
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N97
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ICD-10 code description
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Female infertility
2
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Description of health condition studied
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sexual relational concern
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ICD-10 code
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F41
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ICD-10 code description
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Other anxiety disorders
Primary outcomes
1
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Description
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The score of relational concern dimension of sexual satisfaction questionnaire of Chesley et al
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Timepoint
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Before, after and one month after the end of study
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Method of measurement
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The 6-question relational concern questionnaire, which is one of the dimensions of the multidimensional sexual satisfaction questionnaire of Chesley et al
Intervention groups
1
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Description
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Intervention group: Counseling based on mindfulness will be conducted in eight sessions for 8 weeks (one session per week) by the researcher with the help of a psychiatrist based on the standard Kabat-Zinn protocol, 7 sessions of which will be held by contacting the participants for 30 minutes. . The first meeting will be held in person at Fatemeh Al-Zahra Infertility Center in order to explain the objectives, stages of the study, a summary of the method of implementation of the work verbally, obtaining informed consent and also assuring the participants to keep their information confidential. In the first session and before the consultation, demographic and midwifery questionnaires and sexual relational concern questionnaires will be completed by the samples. Each session will have a goal and during that mindfulness exercises will be done. Also, mindfulness tasks are suggested for women to practice in everyday events. In the intervals between the sessions, the researcher will respond to the calls of the samples to clear their doubts and questions. After a period of 8 weeks, the women's sexual relational concern questionnaire will be completed virtually by the participants. To check the stability of the educational intervention of the present study, after a one-month follow-up period (twelfth week), the samples are again asked to complete the sexual relational concern questionnaire in virtual form.
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Category
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Treatment - Other
2
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Description
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Control group: At Fatemeh Al-Zahra Infertility Center, in order to express the goals, stages of the study, a summary of the method of performing the work verbally, obtaining informed consent, and also assuring the participants to keep their information confidential, we will talk to them and request them. to complete demographic, midwifery and sexual relational concern questionnaires. No intervention will be done for the control group. Again, 8 weeks later and 12 weeks later, the control group will complete the sexual relational concern questionnaire virtually.Routine care includes standard infertility treatments.
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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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Babol 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