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IRCT20230828059292N1 IRCT 2023-09-21 Shahed University The effectiveness of Mindfulness-Based Art Therapy on Tension-Type Headache The efficacy of Mindfulness-Based Art Therapy (MBAT) on reducing anxiety, depression and symptoms of people with Tension-Type Headache (TTH) 2023-09-23 anticipated 20 Complete https://irct.ir/trial/72347 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization unit: Individual Randomization method: simple randomization by coin tossing method. In this way, we consider one of the study groups to be the lion and the other group to be the line, and based on the sample size, the same number of coins are tossed. Concealment method: sealed opaque envelopes. In this way, based on the sample size, envelopes are prepared and each of the random sequences created is recorded on a card, and the cards are placed in the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box respectively. Based on the order in which eligible participants entered the study, one of the envelopes was opened in order, the assigned group of that participant was revealed, and people were randomly assigned to two intervention and control groups. Since there is a possibility of heterogeneity in some primary characteristics in the two groups, using the stratified randomization method, we classify variables such as age, gender, and education and try to eliminate heterogeneity in the groups. N/A Condition 1: Tension-Type Headache. Condition 2: Anxiety. Condition 3: Depression. Intervention 1: Intervention group: session 1: Members get to know each other and the group leader by drawing their names with shapes and colors, Establishing a therapeutic alliance, Explaining the rules of the group and agreeing on the rules, Introducing the program and stating the process of the meetings with emphasis on the principle of confidentiality in the group, The basics of mindfulness and comparing the functional state (Automatic) and the state of being (Conscious)/ Homework: Attention to daily tasks. Session 2: Mindfulness intervention: Eating a raisin with conscious attention (Freeing from the automatic state)/ Art therapy intervention: Face painting of the real and imaginary self/ Homework: Eating with conscious attention. Session 3: Mindfulness intervention: Body monitoring meditation/ Art therapy intervention: Drawing the feelings created in the body and paying attention to the shape and color of these feelings/ Homework: Using awareness attention in normal daily activities. Session 4: Mindfulness intervention: Comparing two ways of thinking and being aware/ Art therapy intervention: Drawing life, emotions and values in it/ Homework: Performing a normal activity with a new quality in the form of conscious attention. Session 5: Mindfulness intervention: Breathing awareness attention meditation/ Art therapy intervention: Drawing the now state of mind with special signs, shapes and colors/ Homework: Calendar of pleasant experiences and related feelings. Session 6: Mindfulness intervention: Sitting meditation (non-selective awareness and awareness attention towards breathing, body and sounds)/ Art therapy intervention: Drawing thoughts, emotions and Unpleasant bodily sensations and their opposite feelings/ Homework: Awareness of the senses are full of tension caused by physical discomfort in different parts of the body. Session 7: Mindfulness intervention: Inviting problems and difficulties and dealing with them in the body/ Art therapy intervention: Drawing feelings of difficulty, dislike of the body and life problems and overcoming them/ Homework: Daily reactive breathing exercise (Breathing consciously during the day). Session 8: Mindfulness intervention: Gateway to conscious attention activity (Pleasant activity)/ Art therapy intervention: Self-advertisement/ Homework: Doing a popular activity consciously. Session 9: Mindfulness intervention: Identifying an encouraging reason to continue awareness attention practices/ Art therapy intervention: Drawing your dreams and values/ Homework: Using mindfulness in daily life. Session 10: Reviewing the previous sessions, Answering questions, Encouraging to continue the exercises and summing up. Intervention 2: Control group: Does not receive treatment and remains on the waiting list. It will have pre-test, post-test and follow-up test. After the last follow-up, receives treatment sessions, if wishes. 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 There is no further information.
public Seyyede Yasaman Zahedi Pur
Faculty of humanities, Shahed university, In front of Imam Khomeini's Holy Shrine, Persian Gulf highway (Tehran-Qom)
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5522 8800 ysm_z@yahoo.com Shahed University scientific Hamid Yaghubi; Mohammad Reza Shairi
Faculty of humanities, Shahed university, In front of Imam Khomeini's Holy Shrine, Persian Gulf highway (Tehran-Qom)
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 2468 ext. 00982151212470 shairi@shahed.ac.ir Shahed University Iran (Islamic Republic of) Suffering from Tension-Type Headache Having symptoms of anxiety and depression Having a minimum middle school education level 18 years 60 years Both Suffering from Migraine Having a chronic physical illness Having a headache caused by traumatic injury or accidents Presence of mental disorders Having or history of substance abuse or dependence The presence of women in pregnancy and breastfeeding G44.2 F06.4 F06.31 Tension-type headache Anxiety disorder due to known physiological condition Mood disorder due to known physiological condition with depressive features Rehabilitation Rehabilitation Intervention group: session 1: Members get to know each other and the group leader by drawing their names with shapes and colors, Establishing a therapeutic alliance, Explaining the rules of the group and agreeing on the rules, Introducing the program and stating the process of the meetings with emphasis on the principle of confidentiality in the group, The basics of mindfulness and comparing the functional state (Automatic) and the state of being (Conscious)/ Homework: Attention to daily tasks. Session 2: Mindfulness intervention: Eating a raisin with conscious attention (Freeing from the automatic state)/ Art therapy intervention: Face painting of the real and imaginary self/ Homework: Eating with conscious attention. Session 3: Mindfulness intervention: Body monitoring meditation/ Art therapy intervention: Drawing the feelings created in the body and paying attention to the shape and color of these feelings/ Homework: Using awareness attention in normal daily activities. Session 4: Mindfulness intervention: Comparing two ways of thinking and being aware/ Art therapy intervention: Drawing life, emotions and values in it/ Homework: Performing a normal activity with a new quality in the form of conscious attention. Session 5: Mindfulness intervention: Breathing awareness attention meditation/ Art therapy intervention: Drawing the now state of mind with special signs, shapes and colors/ Homework: Calendar of pleasant experiences and related feelings. Session 6: Mindfulness intervention: Sitting meditation (non-selective awareness and awareness attention towards breathing, body and sounds)/ Art therapy intervention: Drawing thoughts, emotions and Unpleasant bodily sensations and their opposite feelings/ Homework: Awareness of the senses are full of tension caused by physical discomfort in different parts of the body. Session 7: Mindfulness intervention: Inviting problems and difficulties and dealing with them in the body/ Art therapy intervention: Drawing feelings of difficulty, dislike of the body and life problems and overcoming them/ Homework: Daily reactive breathing exercise (Breathing consciously during the day). Session 8: Mindfulness intervention: Gateway to conscious attention activity (Pleasant activity)/ Art therapy intervention: Self-advertisement/ Homework: Doing a popular activity consciously. Session 9: Mindfulness intervention: Identifying an encouraging reason to continue awareness attention practices/ Art therapy intervention: Drawing your dreams and values/ Homework: Using mindfulness in daily life. Session 10: Reviewing the previous sessions, Answering questions, Encouraging to continue the exercises and summing up. Control group: Does not receive treatment and remains on the waiting list. It will have pre-test, post-test and follow-up test. After the last follow-up, receives treatment sessions, if wishes. The number, duration and severity of headaches and the type of Tension-Type Headache. Timepoint: Before the start of the intervention, The third session, The sixth session, The tenth session, One month after the tenth session, Three months after that. Method of measurement: Tension-Type Headache diagnostic questionnaire. Anxiety score. Timepoint: Before the start of the intervention, The third session, The sixth session, The tenth session, One month after the tenth session, Three months after that. Method of measurement: Depression Anxiety Stress Scales (DASS-21). Depression score. Timepoint: Before the start of the intervention, The third session, The sixth session, The tenth session, One month after the tenth session, Three months after that. Method of measurement: Depression Anxiety Stress Scales (DASS-21). Mental disorders score. Timepoint: Before the start of the intervention, The Fifth session, The tenth session, One month after the tenth session, Three months after that. Method of measurement: Brief Symptom Inventory (BSI-53). Seyyede Yasaman Zahedi Pur Approved 2023-05-14 Ethics committee in medical research of Shahed university Secretariat of ethics committee in biomedical research, Research and technology Vice-chancellor, 2nd floor, Central building, Shahed university complex, In front of Imam Khomeini's Holy Shrine, At the beginning of the Tehran-Qom freeway Tehran Tehran Iran (Islamic Republic of)