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IRCT20201009048974N2 IRCT 2022-01-21 Shahid Beheshti University of Medical Sciences The effectiveness of Mindful Hypnotherapy on psychological aspects and severity of headache in patients with chronic migraine The effectiveness of hypnosis-based mindfulness therapy on psychological aspects and severity of headache in patients with chronic migraine 2021-12-22 anticipated 38 Complete https://irct.ir/trial/61334 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be simple randomization method. the random unit is individuals. 38 patients with chronic migraine will be divided into intervention and control groups by Microsoft Excel software using Rand function. In this way, a table of random numbers will be prepared and the Randbetween function will be created and the patients will be divided into two groups of 19 people respectively, Blinding description: The outcome assessor in data collection after the intervention and the data analyst will be unaware of the objectives of the study. N/A Chronic migraine headache. Intervention 1: Intervention group: Mindful Hypnotherapy. This treatment will be performed in 8 one-hour individual sessions according to the Elkins protocol. Intervention 2: Control group: At first, the control group does not receive any intervention and only the results of their evaluations, which are done by the relevant questionnaires, will be compared with the intervention group. At the end of the study, for all members of the control group, Mindful hypnotherapy intervention will be performed in 8 one-hour individual sessions according to the Elkins protocol. Yes - There is a plan to make this available What will be shared: Participants' data will be shared in the SPSS file using by code of participants (not using first and last name) When: Access to the data will be after the articles are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: Request from the journals where the articles related to this research intend to be published. Where to obtain: By receiving confirmation via email to the main executor or executors of the project How to obtain: Send an email to the main executor or other executors of the project and receive written confirmation through them Comments:
public Hassan Khazraee
arabi St, Taleghani Hospital
Tehran Iran (Islamic Republic of) 11111-11111 +98 21 2293 5548 hassankhazraee@gmail.com Shahid Beheshti University of Medical Sciences scientific Hassan Khazraee
Arabi St, Taleghani hospital
Tehran Iran (Islamic Republic of) 11111-11111 +98 21 2293 5548 hassankhazraee@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Having chronic migraine headaches according to the International Headache Committee (IHS) and the beta version of the Third International Classification of Headache Disorders (ICHD-3 beta) Having informed consent to participate in the research and signing the informed consent form Age range between 18 and 50 years At least a diploma degree Female gender 18 years 50 years Female Having other chronic pain problems Have a history of psychotherapy in the last 6 months Participate in another psychological intervention simultaneously Recent drugs abuse Existence of diagnostic indicators or history of borderline personality disorder, psychosis or schizophrenia due to interference with hypnosis History of epileptic seizures or facial nerve pain G43.701 Chronic migraine without aura, not intractable, with status migrainosus Treatment - Other N/A Intervention group: Mindful Hypnotherapy. This treatment will be performed in 8 one-hour individual sessions according to the Elkins protocol. Control group: At first, the control group does not receive any intervention and only the results of their evaluations, which are done by the relevant questionnaires, will be compared with the intervention group. At the end of the study, for all members of the control group, Mindful hypnotherapy intervention will be performed in 8 one-hour individual sessions according to the Elkins protocol. Psychological inflexibility. Timepoint: In the per-intervention and post-intervention stages for 2 months. Method of measurement: Psychological Inflexibility Pain Scale (PIPS). Pain Acceptance. Timepoint: In the per-intervention and post-intervention stages for 2 months. Method of measurement: Pain acceptance questionnaire (CPAQ). Pain Anxiety. Timepoint: In the per-intervention and post-intervention stages for 2 months. Method of measurement: Pain Anxiety Symptoms Scale (PASS-20). Pain Catastrophizing. Timepoint: In the per-intervention and post-intervention stages for 2 months. Method of measurement: Pain Catastrophizing Scale (PCS). Mindfulness. Timepoint: In the per-intervention and post-intervention stages for 2 months. Method of measurement: Five Facet Mindfulness Questionnaire (FFMQ). Self-Compassion. Timepoint: In the per-intervention and post-intervention stages for 2 months. Method of measurement: Self-Compassion Scale (SCS). Emotion Regulation. Timepoint: In the per-intervention and post-intervention stages for 2 months. Method of measurement: Emotion Regulation Strategies Questionnaire (ERQ). Psychological Distress. Timepoint: In the per-intervention and post-intervention stages for 2 months. Method of measurement: Kessler Psychological Distress Scale (K10). Headache related disability. Timepoint: In the per-intervention and post-intervention stages for 2 months. Method of measurement: Headache related disability questionnaire (HDI). Headache intensity. Timepoint: In the per-intervention and post-intervention stages for 2 months. Method of measurement: Visual Analogue Scale (VAS), McGill Pain Questionnaire (MPQ), Blanchard headache diary. Shahid Beheshti University of Medical Sciences Approved 2022-01-04 Ethics committee of Shahid Beheshti University of Medical Sciences Tehran, Ghods Town (West), between South Flamek and Zarafshan, Iran TV St. - Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor Tehran Tehran Iran (Islamic Republic of)