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IRCT20200705048009N1 IRCT 2020-08-25 Shahroud University of Medical Sciences Evaluation of the effectiveness of cognitive-behavioral hypnotherapy on the sexual function, satisfaction, and intimacy of married women Evaluation of the effectiveness of cognitive-behavioral hypnotherapy on the sexual function, satisfaction, and intimacy of married women of reproductive age 2020-09-22 anticipated 70 Complete https://irct.ir/trial/49438 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: HIP(Hypnotic Induction Profile) hypnosis testing is used to screen women for hypnotic ability. Hypnotic Induction Profile (HIP) is a five-minute clinical assessment method that is standardized in a clinical population and meets the required criteria. The overall test score indicates the convergence of the three characteristics of "indoctrination" with "absorption" and "separation", as well as the evaluation of the degree of "unconsciousness" in the person. The subject experiences a state of hypnosis, and potential functional anxiety is reduced in both the subject and the test taker. The main and specific goal is not to create a state of hypnosis, but to test the capacity of the hypnotic experience. So there is no failure or wrong answer, our goal is to evaluate the response rate. The test begins with the rotation of the eye, which is considered a measure of biological ability and inherent in the individual's experience. During the test, the patient is told to roll her eyes: "Keep your head straight and look up, and while your head is straight, look up at your eyebrows, and now at your head. Close your eyes slowly as you look up." The eye-rolling is graded on a scale of zero to four based on the amount of sclera (white of the eye) that is visible between the lower eyelid and the symmetrical lower margin. If convergence also occurs inside the eye, a degree between one and three is assigned and the convergence score is added to the rotation score. This step takes about five seconds. Eye rolling is part of the induction of hypnosis and is considered as a primary indicator of the ability to experience hypnosis. Also, in many patients, eye-rolling can be a rapid spontaneous induction of hypnosis. Then patients are asked to keep their eyes closed but to relax and focus on an inner feeling of floating. While the subject is doing this, She is told that her left hand will feel light and floating and will float in the air, and this will continue even after the end of the official hypnotic experience, unless the end sign (touching the left hand) to be given. The following seven headings are used to score hypnosis induction: 1- The amount of encouragement that is needed for the subject to create lightness and floating in her left hand and arm. 2. The degree of separation that is experienced after the first-hand flight. 3. The amount of verbal encouragement needed to raise the subject's hand again after the therapist lowers the hand. 4. The presence or absence of a sense of incontinence. 5. The amount of encouragement needed to respond to the end sign 6. The presence or absence of self-forgetfulness 7- Changes in awareness of physical sensation during hypnosis experience. The degree of hypnosis is reflected as an "induction scale score" from zero to 16. A score of five or lower means a lack of usable hypnosis, Randomization description: Since the participants enter the study over time and also for an equal number of people in the intervention and control group, random allocation by 4-block method is used. Sequences were determined using the website https://www.sealedenvelope.com/simple-randomiser/v1/lists using the block method to volume 4. Random sequencing is done by someone outside the research team. Initially, 8 comprehensive health centers in Sabzevar are divided into three categories or homogeneous groups in terms of social and economic status. A center is randomly selected from each category and we sample it according to the population of people covered by that category. Effective communication will be made with women who go to selected health centers for any reason, and if they meet the entry criteria, they will be tested for hypnosis and will be given a sexual function questionnaire. Women who score acceptable will be listed by the researcher and will be coded. The codes will be recorded in the central list. To assign participants to two groups, the person who has the allocation sequence will be determined and this will not be done by the project manager. This assigns individuals to groups in advance and does not create any bias in assigning individuals to groups, Blinding description: Since the nature of the intervention is such that it is in the form of cognitive-behavioral hypnosis sessions, the participants in the intervention can not be blinded. Participants are aware of their group, However, to prevent information leakage, the meeting place will be held outside the comprehensive health centers and away from the eyes of the control group. To blind the data collector, the basic questionnaires are completed before assigning individuals to the two groups, and after the intervention, a person who is not familiar with the group of individuals completes the questionnaires. The data analyst will also not be informed of the group of people. N/A Sexual function, satisfaction and intimacy. Intervention 1: Intervention group: Initially, effective communication will be established with women who go to selected health centers for any reason, and if they meet the entry criteria, they will be tested for hypnosis and will be given female sexual function questionnaire. Individuals who get an acceptable score will be listed by the researcher and will be coded. These women will be randomly assigned to two groups of intervention and control using random appointment software for the clinical trial. They fill the female sexual function questionnaire, Larson's sexual satisfaction, and the standard sexual intimacy questionnaire. For these people, in coordination with themselves, weekly and for 4 weeks in a row, counseling sessions with the cognitive-behavioral hypnotherapy approach will be held. Cognitive Behavioral Hypnotherapy will present by the researcher, which includes 4 individual 60-minute sessions per week. The test is completed immediately after and 1 month after the end of the sessions. The counseling sessions will be conducted by a researcher under the supervision of a counselor who has the necessary education and skills in behavioral cognitive hypnotherapy. Intervention 2: Control group: Initially, effective communication will be established with women who go to selected health centers for any reason, and if they meet the entry criteria, they will be tested for hypnosis and will be given female sexual function questionnaire. Individuals who get an acceptable score will be listed by the researcher and will be coded. These women will be randomly assigned to two groups of intervention and control using random appointment software for the clinical trial. They fill the female sexual function questionnaire, Larson's sexual satisfaction, and the standard sexual intimacy questionnaire. For control group members, no action is taken until the end of the intervention, except for routine care. The researcher accurately records the date of the counseling sessions and the beginning and end of the sessions for each person and completes the post-test forms on time for each person. The control group also completes the post-test forms 1 month later (equivalent to 4 sessions in the intervention group), and the follow-up forms one month later. In order to observe ethics in research for the control group, after the end of sampling and intervention, for these women 1 training session on sexual health with relaxation is held by the researcher. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is According to the sensitivity of the subject of this study, and the request of the participants to keep the information confidential, I am still not sure that sharing this data morally is the right thing to do. I need to think more.
public Zeinab Alavizade
No. 17, 19th Daneshgah Ave., Daneshgah Blvd
Sabzevar Iran (Islamic Republic of) 96188-46388 +98 51 4464 3330 zeinabmid@gmail.com Shahroud University of Medical Sciences scientific Zeinab Alavizade
No. 17, 19th Daneshgah Ave., Daneshgah Blvd
Sabzevar Iran (Islamic Republic of) 96188-46388 +98 51 4464 3330 zeinabmid@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Iranian nationality Being married Living in Sabzevar city At least three years have passed since the marriage Stable living with husband No severe marital conflict (by self-expression) Having at least one child At least one year has passed since the last delivery Middle school and higher education Having no diseases that affect sexual function (cardiovascular, mental, thyroid, cancers, etc.) No history of mental illnesses (based on self-reported) Not taking psychiatric and sleeping pills and hormonal drugs Being available in the next two months Not attending to sex health classes and workshops at other institutions and clinics during the intervention Not seeing a psychologist, counselor, or psychiatrist during the intervention No exposure to the death of loved ones or a seriously stressful event during the last 3 months No addiction to drugs or alcoholic drinks Female sexual function test score lower than 28 Hypnotizability score higher than 5 18 years 40 years Female Lack of necessary cooperation with the researcher Being pregnant Being away from her husband for more than ten days Behavior Behavior Intervention group: Initially, effective communication will be established with women who go to selected health centers for any reason, and if they meet the entry criteria, they will be tested for hypnosis and will be given female sexual function questionnaire. Individuals who get an acceptable score will be listed by the researcher and will be coded. These women will be randomly assigned to two groups of intervention and control using random appointment software for the clinical trial. They fill the female sexual function questionnaire, Larson's sexual satisfaction, and the standard sexual intimacy questionnaire. For these people, in coordination with themselves, weekly and for 4 weeks in a row, counseling sessions with the cognitive-behavioral hypnotherapy approach will be held. Cognitive Behavioral Hypnotherapy will present by the researcher, which includes 4 individual 60-minute sessions per week. The test is completed immediately after and 1 month after the end of the sessions. The counseling sessions will be conducted by a researcher under the supervision of a counselor who has the necessary education and skills in behavioral cognitive hypnotherapy. Control group: Initially, effective communication will be established with women who go to selected health centers for any reason, and if they meet the entry criteria, they will be tested for hypnosis and will be given female sexual function questionnaire. Individuals who get an acceptable score will be listed by the researcher and will be coded. These women will be randomly assigned to two groups of intervention and control using random appointment software for the clinical trial. They fill the female sexual function questionnaire, Larson's sexual satisfaction, and the standard sexual intimacy questionnaire. For control group members, no action is taken until the end of the intervention, except for routine care. The researcher accurately records the date of the counseling sessions and the beginning and end of the sessions for each person and completes the post-test forms on time for each person. The control group also completes the post-test forms 1 month later (equivalent to 4 sessions in the intervention group), and the follow-up forms one month later. In order to observe ethics in research for the control group, after the end of sampling and intervention, for these women 1 training session on sexual health with relaxation is held by the researcher. Sexual function: It is an essential part of life and is part of a woman's health. It is a multidimensional phenomenon and is influenced by psychological biological factors. A person's sexual function is a set of expressions of desire, sexual arousal, and orgasm that occur continuously in a person or couple, enabling the couple to fall in love. Timepoint: Sexual function questionnaire is evaluated three times by individuals in both intervention and control groups: at the beginning of the study (before the intervention), 4 weeks after the beginning of the study (immediately after the end of the counseling sessions). And 4 weeks after the end of the intervention. Method of measurement: The Women's Sexual Function Index is a 19-item questionnaire that measures a woman's sexual function in six areas of sexual function, including sexual desire, sexual arousal, vaginal lubrication, orgasm, satisfaction, and pain during sexual intercourse. A person's total score is equal to the sum of the person's scores in each area, which is a maximum score of 36, and a score of less than 28 indicates undesirable sexual function. A higher score indicates better sexual function. Sexual satisfaction: Sexual satisfaction is a person's pleasant feeling of sexuality and her ability to create mutual pleasure. Sexual satisfaction is the measure of a couple's awareness of the fulfillment of their and their partners' sexual expectations and needs. One of the most important factors in a person's evaluation of marital life and its continuity is the level of sexual satisfaction in couples. Timepoint: Sexual satisfaction questionnaire is evaluated three times by individuals in both intervention and control groups: at the beginning of the study (before the intervention), 4 weeks after the beginning of the study (immediately after the end of the counseling sessions). And 4 weeks after the end of the intervention. Method of measurement: Larson Sexual Satisfaction Questionnaire: The 25-question questionnaire was developed by Larson, Anderson, Niemann, and Holman to assess couples' levels of sexual satisfaction. The subject's response to each material is scored on a five-point scale from never (1) to always (5). A high score on this scale indicates sexual satisfaction. The scores are between 25 and 125, and sexual dissatisfaction is characterized by a score below 50, low satisfaction with a score between 50-75, moderate satisfaction with a score between 76-100, and high satisfaction with a score of more than 100. Sexual intimacy: Sexual intimacy involves the sharing of romantic experiences, the need for physical contact, sexual intercourse, and relationships designed to arouse, stimulate, and satisfy sexual satisfaction. Intimacy is the feeling of closeness, similarity, and romantic or emotional relationship with a partner. This component, as one of the dimensions of marital intimacy, is one of the key factors in assessing a person's quality of life. Timepoint: Sexual intimacy questionnaire is evaluated three times by individuals in both intervention and control groups: at the beginning of the study (before the intervention), 4 weeks after the beginning of the study (immediately after the end of the counseling sessions). And 4 weeks after the end of the intervention. Method of measurement: In 2010, Botlani et al. Prepared a sexual intimacy questionnaire based on reliable scientific sources. The questionnaire asks 30 questions, each of them has a range of 4 options (always, sometimes, rarely, never) with scores of 1 to 4. The maximum score is 120 and the minimum is 30. Higher scores indicate more sexual intimacy between couples. Shahroud University of Medical Sciences Approved 2020-06-27 Ethics Committee of Shahroud University of Medical Sciences 7th of Tir Square, Shahroud University of Medical Sciences and Health Services SHahroud Semnan Iran (Islamic Republic of)