]>
IRCT20201110049332N1 IRCT 2020-11-16 Shahed University Efficacy of hypnotherapy on pain intensity and psychological distress Efficacy of hypnotherapy on pain intensity and psychological distress among women with premenstrual dysphoric disorder: a clinical randomized trial 2020-11-28 anticipated 60 Complete https://irct.ir/trial/52200 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: This controlled clinical trial study is going to be performed in Shahed University in 1390 among female students. Initial screening will be performed by a female employee to detect premenstrual symptoms. After screening, 60 participants are contacted via simple random sampling and shuffling. Upon arrival at the clinic, each invited person receives a sealed envelope with A or B code written on each envelope. This sequence is determined by someone other than the researchers using the site www.randomizer.org. Code A means the control group and code B means the intervention group. Fisher and chi-square tests are also used to homogenize the underlying features, Blinding description: First of all, in order to blind the trial, a PhD student of psychology from out of research group, encode participants information. In this project, blinding means more than just keeping the name of the participants are allocated in treatment or control group hidden. The patients will be blinded in the sense that they do not know whether they are receiving the psychotherapy or not. In this double-blind trial, it is implicit that the assessment of patient outcome is done in ignorance of the treatment received. All study participants and main clinical researchers are prevented from knowing certain information that may somehow influence them. N/A Premenstrual dysphoric disorder. Intervention 1: Intervention group: The use of hypnosis to treat or relieve clinical symptoms and improve the quality of life of people is called hypnotherapy. Hypnotherapy is performed in two main ways: classical hypnotherapy and implicit or Ericksonian hypnotherapy. In both types of hypnotherapy, the patient's mental abilities are used to alleviate, control, or treat the clinical symptoms of the disorder. In this study, hypnotherapy is performed as classical hypnotherapy by using progressive relaxation induction, inductions related to self-confidence and change of attitude, as well as repeated conditionings using condition betting. The treatment program is performed by using classical hypnosis. Using this form of session setting using classical hypnosis, induction of trance using progressive relaxation, conditioning using the key condition agreed between the patient and the therapist and instincts related to self-confidence and changing attitudes derived from Hammond's activities (2015). Thus, the induction of trance begins with the progressive relaxation method, and the end of the trance is performed using abdominal breathing and conditioning to the key of the countdown condition from 5 to 1. The number of sessions is predicted to be 8 based on clinical evidence. The duration of each session is 90 minutes. Intervention 2: Control group: The control group is a group in which individuals are defined as a waiting group and no treatment is used to control experimental error. Yes - There is a plan to make this available What will be shared: Data obtained from patients are published unrecognizably in the primary information table in the article. The collected data will be published simultaneously with the publication of the main article. When: The data will be published at the same time as the main article To whom: Due to the nature of the information, this data will only be available to academic researchers and clinicians Conditions: Simultaneously with the publication of the main article, a way of requesting data is introduced. Also, individuals can analyze the data only if the researchers agree. Where to obtain: Simultaneously with the publication of the main article, a way of requesting data is introduced How to obtain: Initially, the request is sent to the responsible author, after reviewing the group in order to prevent any kind of abuse, the information is sent in the form of a zip file. Comments:
public Leila Heidarinasab
Persian Gulf
Tehran Iran (Islamic Republic of) 33191​18651 +98 21 5514 0585 leilaheidarinasab@yahoo.com Shahed University scientific Leila Heidarinasab
Persian Gulf
Tehran Iran (Islamic Republic of) 33191​18651 +98 21 5514 0585 leilaheidarinasab@yahoo.com Shahed University Iran (Islamic Republic of) Conscious consent to participate in research At least diploma degree Receiving diagnosis of premenstrual disorder based on the PSST premenstrual symptoms screening questionnaire and receiving higher score than28 up to 57 Existence of at least 5 criteria of criteria B and C of DSM-5 according to the clinical interview Being in the age range of 20 to 35 years 20 years 35 years Female Existence of a gynecological disease that has led to the cessation of menstruation and menopause Pregnancy or breastfeeding Abuse of drugs, alcohol or cigarettes Taking drugs that affect the immune system in any clinical condition Use of antidepressant and anti-anxiety psychiatric drugs from any class of drugs Receiving the diagnosis of any other psychiatric disorder with respect to receiving a score higher than 3 in any of the dimensions of SCL-90 clinical symptoms Viewing the threshold criteria for each disorder via clinical interview F32.81 Premenstrual dysphoric disorder Treatment - Other N/A Intervention group: The use of hypnosis to treat or relieve clinical symptoms and improve the quality of life of people is called hypnotherapy. Hypnotherapy is performed in two main ways: classical hypnotherapy and implicit or Ericksonian hypnotherapy. In both types of hypnotherapy, the patient's mental abilities are used to alleviate, control, or treat the clinical symptoms of the disorder. In this study, hypnotherapy is performed as classical hypnotherapy by using progressive relaxation induction, inductions related to self-confidence and change of attitude, as well as repeated conditionings using condition betting. The treatment program is performed by using classical hypnosis. Using this form of session setting using classical hypnosis, induction of trance using progressive relaxation, conditioning using the key condition agreed between the patient and the therapist and instincts related to self-confidence and changing attitudes derived from Hammond's activities (2015). Thus, the induction of trance begins with the progressive relaxation method, and the end of the trance is performed using abdominal breathing and conditioning to the key of the countdown condition from 5 to 1. The number of sessions is predicted to be 8 based on clinical evidence. The duration of each session is 90 minutes Control group: The control group is a group in which individuals are defined as a waiting group and no treatment is used to control experimental error. Pain intensity. Timepoint: Session 1, Session 5, Final Session, two months after the last session. Method of measurement: The Numerical Rating Scale. Psychological distress. Timepoint: Session 1, Session 5, Final Session, two months after the last session. Method of measurement: The Depression Anxiety and Stress Scales-42. Vice Chancellor for Research, Shahed University Approved 2020-10-27 Ethics committee of Shahed University persian gulf Tehran Tehran Iran (Islamic Republic of)