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IRCT20161126031117N15 IRCT 2023-09-24 Mazandaran University of Medical Sciences The effect of counseling on the quality of sexual life and sexual performance of pregnant women The effect of counseling based on the EX-PLISSIT model on the quality of sexual life and sexual function of pregnant women: A randomized controlled trial 2023-10-23 anticipated 60 Complete https://irct.ir/trial/72678 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Blocked random allocation method will be used to randomly assign samples to two intervention groups (consultation based on Ex-PLISSIT model) and control group. This method is usually used 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 assigned to the intervention and control groups of the study in cases where intermediate analyzes are needed during the sampling process. 15 blocks of 4 will be used for allocation, in each block two samples will be considered for the control group and two samples for the intervention group. Random Allocation software 2 will be used to allocate samples to each block after numbering the samples, Blinding description: The Investigator and statistical consultant are blinded, and the pregnant women who meet the inclusion criteria are divided into two groups of 30 people, intervention and control, by random block assignment. By using computer software and choosing a block of four, we randomly assign 60 people into two groups A (intervention group) and B (control group). Based on the list extracted from the software, 60 envelopes are prepared and numbers 1 to 60 are written on them, and group A and group B are written inside them based on the list. According to the order of the pregnant mother, one envelope is considered for each mother. If the letter A is written inside the paper, it will be the intervention group and if the word B is written inside the paper, it will be the control group. The mother is not informed about the codes, and the people who are placed in the groups will be given to the evaluator by the liaison, and for data analysis, the code will be handed over to the professor of statistics. N/A Sexual Function and quality of life of pregnant women. Intervention group: In the intervention group, people will receive 4, 45-minute counseling sessions at an interval of one week, face-to-face and individually. Counseling according to the Ex-PLISSIT model takes place at 4 levels of permission (P), limited information (LI), specific suggestions (SS)) and intensive treatment (IT). The first level of the permission level (P) of the counselor by normalizing and creating a safe and private environment and a suitable therapeutic atmosphere, the client is given permission and opportunity to talk about the problem, feelings and sexual desires. By actively listening and communicating effectively and respecting the client's values and beliefs and away from any judgmental behavior, the counselor hears the client's problems and sexual disorders and communicates with the client using understandable words and language. The second level of limited information (LI) is limited and non-specialized information provided to clients. Providing information, knowledge and awareness about sexual relations and sexual health is one of the important aspects of health care. Giving information about sexual relations during pregnancy in the form of a brochure is given to all pregnant women in the intervention group, but at this stage, the first stage continues, and pregnant mothers are told that a brochure has been prepared by the research team and contains information. It is given to you about sex during pregnancy. Would you like to read it? After reading, you can ask any questions you have and we will be happy to answer them. Do you have any other questions about this? The third stage of special suggestions (SS)) In this stage, the consultant has identified the problems and expectations of the clients and based on the problem solving approach, information is given to deal with the specific problem of each person, for example giving sexual position Suitable for a mother who complains of back or abdominal pain during sexual intercourse or a mother who does not want to have intercourse due to infection. The fourth stage of intensive treatment (IT) may be pregnant mothers with complex physical or mental problems and It is interpersonal where there is a need for specialized intervention to deal with individual issues, for example referral to a gynecologist or a psychiatrist. People who need more specific counseling are referred to a sexologist or will receive more specific counseling based on their needs, and follow-up is done immediately after the intervention and 12 weeks after the intervention.. Yes - There is a plan to make this available What will be shared: The information related to the research is shared with the aim of keeping the names of the people and keeping their identities confidential and complying with the 31 codes of ethics When: 2024 To whom: All researchers and those interested in research Conditions: To conduct review and supplementary research and prenatal care centers Where to obtain: In order to receive data or documents, the responsible author can be reached by email at khanisog343@gmail.com and the midwifery counseling student at habibi71.farangis@gmail.com. If the article is published, you can refer to it according to the journal's address. How to obtain: First, you should send an email to the responsible author of the article and make your request, and if the responsible author and the research team deem it appropriate, the documents and files will be provided in a short period of time. Comments:
public farangis habibi
Muftah St
behshahr Iran (Islamic Republic of) 4839795198 +98 11 3455 0429 habibi71.farangis@gmail.com Mazandaran University of Medical Sciences scientific Dr.Soghra Khani
Vesal street_Amirmazandarani Boulevard_Sari_Mazandaran Province_Iran
sari Iran (Islamic Republic of) 4816715793 +98 11 3336 8918 khanisog343@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) The age of the pregnant woman is 18-35 Have at least a high school education Willingness to participate in the study Iranian nationality Cohabitation with spouse 12-16 weeks of pregnancy 18 years 35 years Female Having a history of chronic and special disease (diabetes, blood pressure, thyroid, neurological disease) Having pregnancy and childbirth complications in the current pregnancy and previous pregnancies (threat of miscarriage, abortion, stillbirth, premature birth, preeclampsia, gestational diabetes) Having mental and social problems, diagnosed with psychiatric problems or taking psychiatric drugs Having a severe family dispute, based on the pregnant mother's own statement Use of special drugs History of alcohol, cigarette and drug use High-risk pregnancy Z70 Counselling related to sexual attitude, behaviour and orientation Behavior Intervention group: In the intervention group, people will receive 4, 45-minute counseling sessions at an interval of one week, face-to-face and individually. Counseling according to the Ex-PLISSIT model takes place at 4 levels of permission (P), limited information (LI), specific suggestions (SS)) and intensive treatment (IT). The first level of the permission level (P) of the counselor by normalizing and creating a safe and private environment and a suitable therapeutic atmosphere, the client is given permission and opportunity to talk about the problem, feelings and sexual desires. By actively listening and communicating effectively and respecting the client's values and beliefs and away from any judgmental behavior, the counselor hears the client's problems and sexual disorders and communicates with the client using understandable words and language. The second level of limited information (LI) is limited and non-specialized information provided to clients. Providing information, knowledge and awareness about sexual relations and sexual health is one of the important aspects of health care. Giving information about sexual relations during pregnancy in the form of a brochure is given to all pregnant women in the intervention group, but at this stage, the first stage continues, and pregnant mothers are told that a brochure has been prepared by the research team and contains information. It is given to you about sex during pregnancy. Would you like to read it? After reading, you can ask any questions you have and we will be happy to answer them. Do you have any other questions about this? The third stage of special suggestions (SS)) In this stage, the consultant has identified the problems and expectations of the clients and based on the problem solving approach, information is given to deal with the specific problem of each person, for example giving sexual position Suitable for a mother who complains of back or abdominal pain during sexual intercourse or a mother who does not want to have intercourse due to infection. The fourth stage of intensive treatment (IT) may be pregnant mothers with complex physical or mental problems and It is interpersonal where there is a need for specialized intervention to deal with individual issues, for example referral to a gynecologist or a psychiatrist. People who need more specific counseling are referred to a sexologist or will receive more specific counseling based on their needs, and follow-up is done immediately after the intervention and 12 weeks after the intervention. Sexual Function of pregnant women. Timepoint: Before the intervention, immediately after the intervention, 12 weeks after the intervention. Method of measurement: FSFI Female (Sexual Function Index) Questionnaire. Quality of sexual life. Timepoint: Before the intervention, immediately after the intervention, 12 weeks after the intervention. Method of measurement: Questionnaire of the quality of women's sexual life by Simond et al. (2005). Mazandaran University of Medical Sciences Approved 2023-08-22 Ethics committee of Mazandaran University of Medical Sciences Iran, sari sari Mazandaran Iran (Islamic Republic of)