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IRCT20101013004922N2 IRCT 2018-02-09 Islamic Azad University Laughter therapy and cognitive behavior therapy among dialysis patients Mental health and hopefulness following laughter therapy and cognitive behavior therapy among dialysis patients 2017-03-27 anticipated 145 Complete https://irct.ir/trial/29106 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Then patients were assiged to 3 groups: LT (n=48), CBT (n=48) and the control group (n=49) through the computer-generated randomization procedure. N/A Chronic kidney disease. Intervention 1: Intervention group A: laughter therapy: In this study, 8 one-hour Laughter Therapy (LT) sessions were held from April 22, 2017 to May 31, 2017. The researcher (Sima Vadaei) is a laughter therapist and has a certificate from the Iran Laughter Club. During the first session, exercises such as deep respiration, physical movements (clapping), induction of a feeling of gratitude toward God and laughing in a shy manner (by placing the hands over the eyes) were practiced. During the subsequent sessions, drills such as laughing with a loud sound (gaff), long laughers and other kinds of laughing were presented in association with physical exercises, deep respiration and focus on positive aspects of life. Intervention 2: Intervention group B: Cognitive behavior therapy: In this study, 8 one-hour Cognitive Behaviour Therapy (CBT) sessions were held from April 22, 2017 to May 31, 2017. The researcher (Sima Vadaei) has an official certificate on cognitive‒behavioral interventions under the supervision of Dr. Mahdi Nasre Esfahani, who is a psychiatrist. The contents of the sessions were confirmed by psychologists, and they were implemented through counseling with them. The contents of each session consisted of reviewing the drills of the previous session, instructing new subjects, practicing and assigning the next session’s exercises. During the first session, some explanations were provided about the A-B-C system, behaviors and physiology. During the subsequent sessions, the cognitive therapy of mental health, positive thinking approach, classification of beliefs, data organizing, altering beliefs, rational analysis, desensitization, etc., were presented and exercised. Intervention 3: Control group: Routine therapy with dialysis. 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 No decision has yet been made in this regard
public Mohammad Sahenalzamani
6th Floor, IAU Central Organization, Shohadaye Hesarak Blvd, Daneshgah Square, Sattari Expy, Tehran, I.R.Iran.
Tehran Iran (Islamic Republic of) 1477893855 +98 21 4735 1601 m_szamani@iautmu.ac.ir Islamic Azad University scientific Mohammad Sahebalzamani
6th Floor, IAU Central Organization, Shohadaye Hesarak Blvd, Daneshgah Square, Sattari Expy, Tehran, I.R.Iran.
Tehran Iran (Islamic Republic of) 1477893855 +98 21 2281 1045 m_szamani@iautmu.ac.ir Islamic Azad University Iran (Islamic Republic of) The existence of patient’s permanent medical records in selected hospitals Willingness to be included in the study The ability to read and write in Persian Absence of any signs of mental retardation No concomitant use of medications for mental disorders Absence of any report on severe stress during the previous 6-month period No history of participation in similar interventions Being treated with dialysis at last 6 months no limit no limit Both Unwillingness to complete intervention process Absence for more than 2 sessions Facing with major physical or mental conditions during intervention period which can affect the study results Emigration from the region where the study was being carried out N18 Chronic kidney disease (CKD) Behavior Behavior Treatment - Other Intervention group A: laughter therapy: In this study, 8 one-hour Laughter Therapy (LT) sessions were held from April 22, 2017 to May 31, 2017. The researcher (Sima Vadaei) is a laughter therapist and has a certificate from the Iran Laughter Club. During the first session, exercises such as deep respiration, physical movements (clapping), induction of a feeling of gratitude toward God and laughing in a shy manner (by placing the hands over the eyes) were practiced. During the subsequent sessions, drills such as laughing with a loud sound (gaff), long laughers and other kinds of laughing were presented in association with physical exercises, deep respiration and focus on positive aspects of life. Intervention group B: Cognitive behavior therapy: In this study, 8 one-hour Cognitive Behaviour Therapy (CBT) sessions were held from April 22, 2017 to May 31, 2017. The researcher (Sima Vadaei) has an official certificate on cognitive‒behavioral interventions under the supervision of Dr. Mahdi Nasre Esfahani, who is a psychiatrist. The contents of the sessions were confirmed by psychologists, and they were implemented through counseling with them. The contents of each session consisted of reviewing the drills of the previous session, instructing new subjects, practicing and assigning the next session’s exercises. During the first session, some explanations were provided about the A-B-C system, behaviors and physiology. During the subsequent sessions, the cognitive therapy of mental health, positive thinking approach, classification of beliefs, data organizing, altering beliefs, rational analysis, desensitization, etc., were presented and exercised. Control group: Routine therapy with dialysis Mental health. Timepoint: Before and 2 days after intervention. Method of measurement: Symptom Checklist (SCL-90-R) was used before intervention and 2 days after it. Hopefulness. Timepoint: Before and 2 days after intervention. Method of measurement: Snyder Hope Scale (SHS). Islamic Azad University Approved 2017-03-14 Ethics Committee of Islamic Azad University Tehran Medical Sciences Branch Tehran Province, Tehran, Danesh Rd Tehran Tehran Iran (Islamic Republic of)