]>
IRCT20220706055393N1 IRCT 2022-09-10 Islamic Azad University The Effect of Compassion Therapy on Chronic Pain The Effec of Compassion-Focused Therapy on Cognitive Emotion Regulation and Pain Perception in Patients With Chronic Pain 2022-09-18 anticipated 40 Complete https://irct.ir/trial/64816 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the study population includes all female patients aged 40 to 65 with chronic pain who have referred to the Pain Clinic of Akhtar Hospital. The samples were selected using the convenience sampling method after the preliminary interview and based on the inclusion and exclusion criteria of study, and then were divided into two control and intervention groups by Simple Randomization and lottery method. In the simple randomization by lottery, first the names of 40 selected patients are written on sheets and then placed inside the vase; then the names of 20 people are drawn out of the vase. The names of 20 people removed from the vase are chosen as the first group and the names remaining in the vase are chosen as the second group. In the following, lots were drawn between the first group and the second group, and according to the lottery, the name of the group that was removed from the vase was placed in the intervention group and the name of the group inside the vase was placed in the control group. Finally, we will have two intervention (including 20 people) and control (including 20 people) groups using simple randomization by lottery. N/A Chronic Pain. Intervention 1: Intervention group: Following the selection of 40 subjects and assigning them to the two control and intervention groups by lottery method (draws), the intervention group will undergo Compassion-Focused Therapy (CFT). Moreover, both control and intervention groups completed demographic, McGill Pain Questionnaire (MPQ), Self-Compassion Scale-Long Form Questionnaire (SCS-LF), and Cognitive Emotion Regulation Questionnaires (CERQ), once before the intervention and once after the intervention. In this group, each subject will individually undergo eight 60-minute sessions of CFT, once a week; here is a brief description of the sessions. The first session: Familiarity with the general principles of Compassion-Focused Therapy (CFT), assessment and evaluation of shame, self-criticism, self-compassion, and soothing breathing rhythm training. The second session: Introducing the three emotion regulation systems and how they affect the person, the conflicts between the old brain and the new brain, and explaining the difference between the threat-focused mind and the compassionate mind. Training mindfulness, and introducing mindfulness exercises: breathing exercises, eating and touching raisins. The third session: Familiarity with the characteristics of compassionate people, compassion towards others, cultivating a feeling of warmth and kindness towards oneself, training the compassion expressing styles and methods using expressions (I feel safe, I am kind to myself), cultivating and understanding the fact that others also have flaws and problems (cultivating a sense of human commonality) versus self-destructive feelings and shame, training compassionate mental imagery. The fourth session: Focusing on the compassionate self, discussing the characteristics of the self-compassionate individuals, exercising the Gestalt empty chair (internal dialogue between the three thoughts of the self-critic, the compassionate self, and the self-criticized), performing a mental imagery exercise on the compassionate self, and accepting mistakes to enhance changes. The fifth session: Compassion skills training: compassionate attention, compassionate reasoning, compassionate behavior, compassionate imagery, compassionate feeling, compassionate sensory experience in compassion for self and others. Examining a person's compassionate or traumatic behavior in real-life threatening situations, training how to mentally visualize a compassionate safe place. The sixth session: Training love and affection meditation and cultivating compassion towards others, training forgiveness, focusing on self-compassion towards others. The seventh session: Training acceptance of issues and facing different challenges and changes ahead, training in writing compassionate letters for yourself and others, training the method of "recording and keeping a diary of compassion-based real situations and the person's performance in that situation". The eighth session: Fear of self-compassion, identifying and addressing thoughts hindering the development of self-compassion, reviewing and practicing the skills presented in the previous sessions to help the participant deal with different situations in their life in different ways, solutions to maintain and apply this therapy method in everyday life, and in the end, re-filling demographic, McGill Pain Questionnaire (MPQ), Self-Compassion Scale-Long Form Questionnaire (SCS-LF), and Cognitive Emotion Regulation Questionnaires (CERQ) by subjects. Intervention 2: Control group: A sample of 40 subjects is selected and then assigned into two groups of control and intervention by lottery method (draws). The control group will receive no intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Kimiya Hashemi Kashi
Islamic Azad University, University Town, Semnan
Semnan Iran (Islamic Republic of) 3513137111 +98 23 3165 6565 kimiya.hashemi13701112@gmail.com Islamic Azad University scientific Kimiya Hashemi Kashi
Islamic Azad University, University Town, Semnan
Semnan Iran (Islamic Republic of) 3513137111 +98 23 3165 6565 kimiya.hashemi13701112@gmail.com Islamic Azad University Iran (Islamic Republic of) Female patients aged 40 to 65 years Definitive diagnosis of chronic pain for at least 6 months by an anesthesiologist (Pain Fellowship) Healthy individuals and chronic pain patients with normal ranges for diabetes, blood pressure, and thyroid (fasting blood sugar less than or equal to 110 mg/dL, high blood pressure less than or equal to 140 on 90 mmHg, normal thyroid according to the laboratory kit) Not having rheumatology diseases or being under control The presence of problems with Cognitive Emotion Regulation and Pain Perception based on clinical interview and Cognitive Emotion Regulation Questionnaire (CERQ) and McGill Pain Questionnaire (MPQ) Minimum literacy Absence of vision and hearing problems 40 years 65 years Female History of attending the Compassion-Focused Therapy (CFT) training programs Drug and alcohol addiction Mental retardation disorder Cancer patients Psychotic disorder patients G89.4 Chronic pain syndrome N/A N/A Intervention group: Following the selection of 40 subjects and assigning them to the two control and intervention groups by lottery method (draws), the intervention group will undergo Compassion-Focused Therapy (CFT). Moreover, both control and intervention groups completed demographic, McGill Pain Questionnaire (MPQ), Self-Compassion Scale-Long Form Questionnaire (SCS-LF), and Cognitive Emotion Regulation Questionnaires (CERQ), once before the intervention and once after the intervention. In this group, each subject will individually undergo eight 60-minute sessions of CFT, once a week; here is a brief description of the sessions. The first session: Familiarity with the general principles of Compassion-Focused Therapy (CFT), assessment and evaluation of shame, self-criticism, self-compassion, and soothing breathing rhythm training. The second session: Introducing the three emotion regulation systems and how they affect the person, the conflicts between the old brain and the new brain, and explaining the difference between the threat-focused mind and the compassionate mind. Training mindfulness, and introducing mindfulness exercises: breathing exercises, eating and touching raisins. The third session: Familiarity with the characteristics of compassionate people, compassion towards others, cultivating a feeling of warmth and kindness towards oneself, training the compassion expressing styles and methods using expressions (I feel safe, I am kind to myself), cultivating and understanding the fact that others also have flaws and problems (cultivating a sense of human commonality) versus self-destructive feelings and shame, training compassionate mental imagery. The fourth session: Focusing on the compassionate self, discussing the characteristics of the self-compassionate individuals, exercising the Gestalt empty chair (internal dialogue between the three thoughts of the self-critic, the compassionate self, and the self-criticized), performing a mental imagery exercise on the compassionate self, and accepting mistakes to enhance changes. The fifth session: Compassion skills training: compassionate attention, compassionate reasoning, compassionate behavior, compassionate imagery, compassionate feeling, compassionate sensory experience in compassion for self and others. Examining a person's compassionate or traumatic behavior in real-life threatening situations, training how to mentally visualize a compassionate safe place. The sixth session: Training love and affection meditation and cultivating compassion towards others, training forgiveness, focusing on self-compassion towards others. The seventh session: Training acceptance of issues and facing different challenges and changes ahead, training in writing compassionate letters for yourself and others, training the method of "recording and keeping a diary of compassion-based real situations and the person's performance in that situation". The eighth session: Fear of self-compassion, identifying and addressing thoughts hindering the development of self-compassion, reviewing and practicing the skills presented in the previous sessions to help the participant deal with different situations in their life in different ways, solutions to maintain and apply this therapy method in everyday life, and in the end, re-filling demographic, McGill Pain Questionnaire (MPQ), Self-Compassion Scale-Long Form Questionnaire (SCS-LF), and Cognitive Emotion Regulation Questionnaires (CERQ) by subjects. Control group: A sample of 40 subjects is selected and then assigned into two groups of control and intervention by lottery method (draws). The control group will receive no intervention. Pain Perception. Timepoint: Pain perception in patients with chronic pain is measured once before the intervention and once after the intervention (at the end of the eighth session). In the control group, they are measured once at the same time as the sample group and once two months later. Method of measurement: Pain perception is measured by McGill Pain Questionnaire (MPQ). Cognitive Emotion Regulation. Timepoint: Cognitive Emotion Regulation in patients with chronic pain is measured once before the intervention and once after the intervention (at the end of the eighth session). In the control group, they are measured once at the same time as the sample group and once two months later. Method of measurement: Cognitive emotion regulation is measured by the Cognitive Emotion Regulation Questionnaire (CERQ). Self-Compassion. Timepoint: Self-Compassion, in patients with chronic pain, is measured once before the intervention and once after the intervention (at the end of the eighth session). In the control group, they are measured once at the same time as the sample group and once two months later. Method of measurement: Self-Compassion is measured by the Self-Compassion Scale-Long Form Questionnaire (SCS-LF). Islamic Azad University Approved 2022-06-22 Ethics Committee of Islamic Azad University Semnan Branch University Town, Semnan Semnan Semnan Iran (Islamic Republic of)