Protocol summary
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Study aim
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Comparison of the effect of online problem-solving-based sexual counseling on anxiety and sexual intimacy in women with recurrent pregnancy loss
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Design
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A experimental study is conducted using a parallel clinical trial method with two parallel groups (each group of 35 people) randomized without blinding on the anxiety and sexual intimacy of 70 qualified women. Sampling is done by simple random allocation method using randomization site.
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Settings and conduct
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In the recurrent pergnancy loss clinic of Yazd Reproductive Medicine Research Institute, invitation to study, sample selection, random allocation and psychological intervention are carried out by the second researcher under the supervision of the first, third and fourth researchers.
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Participants/Inclusion and exclusion criteria
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Having a history of at least two recurrent pregnancy loss
Women aged 18-45 years
Not having major stress such as divorce and death of relatives in the last 3 months
Having a cellphone and access to the ITA internal messaging network
Being Iranian;
pregnancy
patient’s or her spouse’s affliction with serious psychological disorders such as severe depression and psychosis,
consumption of any drug affecting sexual relations by the patient or her spouse (self-reported),
history of participating in sexual health education and counseling sessions
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Intervention groups
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For the intervention group, 8 training sessions will be held online using voice and the possibility of questions and answers with private chat in the internal messaging network of ITA based on the developed program, and the control group will have the same sessions in the form of pamphlets and the possibility of questions and They will receive an answer with a phone call
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Main outcome variables
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Change in mean scores of anxiety and sexual intimacy
General information
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Reason for update
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The intervention is finish.
Hello. Two minor items were edited to match the intervention performed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220620055229N1
Registration date:
2023-02-14, 1401/11/25
Registration timing:
prospective
Last update:
2024-04-10, 1403/01/22
Update count:
2
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Registration date
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2023-02-14, 1401/11/25
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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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2023-02-04, 1401/11/15
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Expected recruitment end date
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2023-04-27, 1402/02/07
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Actual recruitment start date
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2023-03-06, 1401/12/15
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Actual recruitment end date
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2023-08-06, 1402/05/15
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Trial completion date
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2023-08-11, 1402/05/20
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Scientific title
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Investigating the effect of sexual counseling based on online problem solving on anxiety and sexual intimacy in women with recurrent pregnancy loss
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Public title
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Investigating sexual counseling based on online problem solving on anxiety and sexual intimacy in women with recurrent pregnancy loss
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having a history of at least two recurrent pregnancy loss
Women aged 18-45 years
Not having major stress such as divorce and death of relatives in the last 3 months
Having a Cellphone and access to ITA's internal messenger network
Being Iranian
Exclusion criteria:
Pregnancy
patient’s or her spouse’s affliction with serious psychological disorders such as severe depression and psychosis
consumption of any drug affecting sexual relations by the patient or her spouse (self-reported)
history of participating in sexual health education and counseling sessions
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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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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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No information
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Sample size
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Target sample size:
70
Actual sample size reached:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The first-generation random allocation method was used to assign the eligible participants into two intervention and active control groups, each participant was given a number from 1 to 70.
Then, using the website http://www.randomization.com. participants were randomly assigned into two blocks of 35, C and D. A person external to the study used a random lottery method to select each block as an intervention or active control group.
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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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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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2023-01-24, 1401/11/04
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Ethics committee reference number
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IR.SSU.REC.1401.067
Health conditions studied
1
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Description of health condition studied
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Sexual dysfunction counseling
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ICD-10 code
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N96
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ICD-10 code description
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Recurrent pregnancy loss
Primary outcomes
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Description
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Change in mean sexual anxiety scores
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Timepoint
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Baseline, end of intervention in week 8 and end of intervention in week 12
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Method of measurement
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Sexual anxiety Index (Davis et al.)
Secondary outcomes
1
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Description
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Change in mean sexual intimacy scores
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Timepoint
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Baseline, end of intervention in week 8 and end of intervention in week 12
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Method of measurement
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Sexual Intimacy Index (Bagarouzi et al.)
Intervention groups
1
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Description
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Intervention group: For the intervention group, 8 training sessions will be held online using voice and the possibility of questions and answers with private chat on the internal messaging network of ITA based on the program developed by the second researcher and under the supervision of the first and third researchers. The content of the sessions Includes: explanations about the terms sexual anxiety, sexual intimacy, frequent abortion and problem solving approach, teaching logical problem solving and defining the problem clearly and objectively, setting achievable and realistic goals to solve the problem, learning functional ABCs, training Effective problem solving in real life is through combining emotions and logical thinking, choosing the best solution, evaluating and reviewing. At the beginning of each session, a summary of the previous sessions will be reviewed and the assigned tasks related to the previous session will be reviewed by the researcher. they turn Women are asked to participate in discussions and raise their questions. At the end of each session, a summary of the important topics discussed is presented and people's questions are answered, and women are asked to do their homework in the next sessions.
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Category
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Behavior
2
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Description
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Control group: The control group will receive 8 sessions of problem solving advice in the form of pamphlets and the possibility of questions and answers by telephone. The content of the sessions includes explanations about the terms sexual anxiety, sexual intimacy, frequent abortion and problem solving approach, teaching logical problem solving and defining the problem clearly and objectively, setting achievable and realistic goals to solve the problem, learning functional ABCs, Teaching effective real-life problem solving through combining emotions and logical thinking, choosing the best solution, evaluating and revising
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Category
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Behavior
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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Yazd 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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Yes - There is 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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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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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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Not applicable
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Title and more details about the data/document
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All personal data of participants can be shared after de-identification.
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When the data will become available and for how long
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After printing the results
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To whom data/document is available
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The data will be available for researchers working in academic and scientific institutions, and people working in the industry can apply to receive them.
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Under which criteria data/document could be used
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Scientific use
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From where data/document is obtainable
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mah-bokaie@yahoo.com
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What processes are involved for a request to access data/document
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One week after receiving the applicant's email.
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Comments
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