Efficacy of hypnotherapy on pain intensity and psychological distress among women with premenstrual dysphoric disorder: a clinical randomized trial

1- Efficacy of hypnotherapy protocol on perceived pain intensity in women with premenstrual dysphoric disorder 2- Efficacy of hypnotherapy protocol on reducing psychological distress in women with premenstrual dysphoric disorder 3- Determining the permanence of hypnotherapy results on reducing the intensity of perceived pain after 3 months of follow-up in women with premenstrual dysphoric disorder 4- Determining the permanence of hypnotherapy treatment results on reducing the level of psychological distress after 3 months in women with premenstrual dysphoric disorder

Clinical trial of control group, single intervention group, double-blind, randomized, use of random numbers Phone number

The study population is all female students of Shahed University in 1999. The research is conducted at Shahed University. evaluation and treatment and random allocation are done by different people without knowing each other. The hypnotherapy protocol is also held in 8 sessions

Entry: 1. Conscious satisfaction 2. At least a diploma 3. Diagnosis of premenstrual disorder 4. Being in the age range of 18 to 35 years No entry: 1. A gynecological disease that has led to the cessation of menstruation 2. Menopause 3. Pregnancy or breastfeeding 4. Consumption of drugs, alcohol or cigarettes 5. Taking drugs that affect the immune system in any clinical situation 6. Use of antidepressant and anti-anxiety psychiatric drugs from any class of drugs 7. Receive a diagnosis of any other psychiatric disorder

The Intervention group: the treatment program is performed via using classical hypnosis. The control group: includes a group of patients who have been diagnosed with premenstrual dysphoric disorder but are in untreated conditions.

Change in pain intensity; Change in the level of psychological distress

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.

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.

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.

The data will be published at the same time as the main article

Due to the nature of the information, this data will only be available to academic researchers and clinicians

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.

Simultaneously with the publication of the main article, a way of requesting data is introduced

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.