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IRCT20110827007422N4 IRCT 2021-09-18 Mazandaran University of Medical Sciences The Effect of Hypnotherapy on Pain Intensity in Endometriosis Patients Treated With Dinogest Evaluation of the Effectiveness of Hypnotherapy on Pain Intensity in Endometriosis Patients Treated With Dinogest: A Randomized Controlled clinical trial 2021-09-23 anticipated 22 Complete https://irct.ir/trial/58711 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Due to the Fact that the Final Sample Size will be Determined after the Pilot Study, at Present the Number of Final Blocks is Not Known, but the Blocking Method will be Used.The blocks will be TTCC, TCTC, TCCT, CCTT, CTCT, CTTC, where T is for the intervention group and C is for the control group. The numbers will be randomly generated by the RANDBETWEEN command in Excel software in the range 0 to 6. Depending on the production values of one of the blocks (for production number between 0 to 1 CTTC block, for production number between 1 to 2 CTCT blocks and so on) will be selected and samples will be allocated accordingly, Blinding description: Blinding will be done at the Level of Outcome Assessor and Evaluation at the Level of Analysis. The Person who will Evaluate the Outcome and Analyze the Data does not Know the Status of the Samples and does not Know which Participant is in the Control and Intervention Group. N/A Condition 1: Endometriosis. Condition 2: Pain. Condition 3: Quality of Life. Condition 4: Women's sexual function. Intervention 1: Intervention group: In Addition to the Routine Treatment, which Includes 2 mg of Dienogest Tablets Daily, Hypnotherapy in 8 Sessions, the First Session in Person and Individually and the Other 7 Sessions once a Week, Individually, Online (via WhatsApp virtual network) and It will be Held for 30-45 Minutes, and at the end of Each Session, an File Recording of the Session will be Sent to Each Participant in the Intervention Group to Perform Hypnosis Exercises at Home at Least Twice a Day (for 30 Minutes). And Mark the Number of Exercises in the Form that will be provided to them. Intervention 2: Control group: During the Study, Except for the Routine Treatment of 2 mg Dienogest Tablets Daily, no Intervention is Performed only After the Completion of the Research Process, In Order to Observe Research Ethics, Hypnotherapy Sessions will be Offered to the Subjects of the Control Group of the Recorded Files. 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 Undecided - It is not yet known if there will be a plan to make this available
public Roja Shahriyaripoor
Nasibeh Nursing and Midwifery Faculty, Vesal Shirazi Avenue
Sari Iran (Islamic Republic of) 4816715793 +98 11 3337 4750 Rojashahriyaripoor1369@gmail.com Mazandaran University of Medical Sciences scientific Jila Ganji
Nasibeh Nursing and Midwifery Faculty, Vesal Shirazi Avenu
Sari Iran (Islamic Republic of) 4816715793 +98 11 3337 4750 zhila.ganji@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Women with Endometriosis (Confirmed by Laparoscopy or Laparotomy and Confirmed by Histology) Treated with Dynogest Married Women 45-18 Years Complaints of Painful Menstruation or Painful Intercourse or Pelvic Pain With a Minimum Score of 5 Cm on a Visual Analog Scale Pain at the Start of Treatment Having a Smartphone Internet Access 18 years 45 years Female People With a History of Endometriosis Treatment With Surgery (Laparotomy, Llaparoscopy and Hysterectomy) History of Major or Minor Psychiatric Disorder in a First-Degree Individual or Family (Father, Mother, Sister, Brother, Child) People Who Currently Use Other Non-Pharmacological Methods to Reduce Pain (Such as: Yoga, Herbal Medicine, Acupressure, Acupuncture, Traditional Medicine, Biofeedback, etc.) Existence of Concomitant Cancer, Treatment of Anxiety or Uncontrolled Depression and Seizures N80 Endometriosis Treatment - Other Other Intervention group: In Addition to the Routine Treatment, which Includes 2 mg of Dienogest Tablets Daily, Hypnotherapy in 8 Sessions, the First Session in Person and Individually and the Other 7 Sessions once a Week, Individually, Online (via WhatsApp virtual network) and It will be Held for 30-45 Minutes, and at the end of Each Session, an File Recording of the Session will be Sent to Each Participant in the Intervention Group to Perform Hypnosis Exercises at Home at Least Twice a Day (for 30 Minutes). And Mark the Number of Exercises in the Form that will be provided to them Control group: During the Study, Except for the Routine Treatment of 2 mg Dienogest Tablets Daily, no Intervention is Performed only After the Completion of the Research Process, In Order to Observe Research Ethics, Hypnotherapy Sessions will be Offered to the Subjects of the Control Group of the Recorded Files. Pain. Timepoint: Before the iIntervention, Immediately After the Intervention, one Month After the Intervention. Method of measurement: VAS Pain Visual Scale Questionnaire. Quality of Life. Timepoint: Before the Intervention, Immediately and one Month after the Intervention. Method of measurement: Endometriosis Quality of Life Questionnaire EHP-5. Sexual Function. Timepoint: Before the Intervention, Immediately and one Month after the Intervention. Method of measurement: FSFI Women's Sexual Performance Index Questionnaire. Mazandaran University of Medical Sciences Approved 2021-08-29 Ethics Committee of Mazandaran University of Medical Sciences Deputy of Research and Technology of Mazandaran University of Medical Sciences, Moalem Square Sari Mazandaran Iran (Islamic Republic of)