Determining the effectiveness of telephone counseling based on mindfulness on sexual anxiety of infertile women in Babol city
Design
Clinical trial with control group, open label, random assignment in control group and intervention with random blocks of 4 by online randomizer, on 60 participants.
Settings and conduct
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 anxiety 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 anxiety questionnaire virtually.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
sexual anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180218038783N8
Registration date:2024-01-20, 1402/10/30
Registration timing:prospective
Last update:2024-01-20, 1402/10/30
Update count:1
Registration date
2024-01-20, 1402/10/30
Registrant information
Name
Fereshteh Behmanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0504
Email address
f.behmanesh@mubabol.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2027-01-21, 1405/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of telephone counseling based on mindfulness on sexual anxiety of infertile women of Babol city
Public title
Effectiveness of telephone counseling based on mindfulness on sexual anxiety of infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
To 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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].
Blinding (investigator's opinion)
Single blinded
Blinding description
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
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences. Keshavarz St.
City
Babol
Province
Mazandaran
Postal code
4774547176
Approval date
2023-11-27, 1402/09/06
Ethics committee reference number
IR.MUBABOL.REC.1402.141
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
2
Description of health condition studied
sexual anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
Primary outcomes
1
Description
The score of sexual anxiety dimension of sexual anxiety questionnaire of Chesley et al
Timepoint
Before, after and one month after the end of study
Method of measurement
The 6-question sexual anxiety questionnaire, which is one of the dimensions of the multidimensional sexual satisfaction questionnaire of Chesley et al
Secondary outcomes
empty
Intervention groups
1
Description
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 anxiety 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 anxiety 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 anxiety questionnaire in virtual form.
Category
Treatment - Other
2
Description
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 anxiety 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 anxiety questionnaire virtually.Routine care includes standard infertility treatments.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatima Al-Zahra Infertility Center
Full name of responsible person
Fereshteh Behmanesh
Street address
Babol University of Medical Sciences, Keshavarz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 911 213 5312
Email
f.behmanesh2015@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajab Nia
Street address
Babol University of Medical Sciences, Keshavarz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
ramazan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Keshavarz St
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 911 213 5312
Email
f.behmanesh2015@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Keshavarz St
City
Babol
Province
Mazandaran
Postal code
4774547176
Phone
+98 911 213 5312
Email
f.behmanesh2015@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kargar Square, Keshavarz St
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 911 213 5312
Email
f.behmanesh@gmail.com
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