Determine the effectiveness of Compassion-Focused Therapy (CFT) on Cognitive Emotion Regulation (CER) and Pain Perception in female patients with Chronic Pain.
Design
Clinical trial of two control and intervention groups, randomized by lottery method (draws), with a sample size of 40 subjects
Settings and conduct
The population consists of all female patients with chronic pain in 2022. This is a randomized controlled trial using a pre-test-post-test design with a control group receiving the usual care of a standard study. The intervention will be done in Akhtar Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 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 to110 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 and McGill Pain Questionnaire; Minimum literacy; Absence of vision and hearing problems; Exclusion criteria: History of attending the Compassion-Focused Therapy training programs; Drug and alcohol addiction; Mental retardation disorder; Cancer patients; Psychotic disorder patients.
Intervention groups
Intervention group: The intervention group (20 subjects), will individually undergo eight 60-minute sessions of Gilbert Compassion-Focused Therapy. Control group: The control group (20 subjects) will not receive any intervention and they will be on the waiting list.
The Effec of Compassion-Focused Therapy on Cognitive Emotion Regulation and Pain Perception in Patients With Chronic Pain
Public title
The Effect of Compassion Therapy on Chronic Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
History of attending the Compassion-Focused Therapy (CFT) training programs
Drug and alcohol addiction
Mental retardation disorder
Cancer patients
Psychotic disorder patients
Age
From 40 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University Semnan Branch
Street address
University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Approval date
2022-06-22, 1401/04/01
Ethics committee reference number
IR.IAU.SEMNAN.REC.1401.021
Health conditions studied
1
Description of health condition studied
Chronic Pain
ICD-10 code
G89.4
ICD-10 code description
Chronic pain syndrome
Primary outcomes
1
Description
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)
2
Description
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)
3
Description
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)
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
N/A
2
Description
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.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Dr. Mahshid Ghasemi
Street address
Akhtar Hospital, Azar Dead End, Sharifi Menesh St., Paul Rumi St., Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 2200 1072
Fax
+98 21 2352 3707
Email
mahshid.ghasemi@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Karim Sohrabi
Street address
5 km of Semnan-Damqan Road
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3165 6180
Fax
+98 23 3365 4231
Email
amir_sohraby@aut.ac.ir
Web page address
https://semnan.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kimiya Hashemi Kashi
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3165 6565
Fax
+98 23 3365 4231
Email
kimiya.hashemi13701112@gmail.com
Web page address
https://semnan.iau.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kimiya Hashemi Kashi
Position
University Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3165 6565
Fax
+98 23 3365 4231
Email
kimiya.hashemi13701112@gmail.com
Web page address
https://semnan.iau.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kimiya Hashemi Kashi
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3165 6565
Fax
+98 23 3365 4231
Email
kimiya.hashemi13701112@gmail.com
Web page address
https://semnan.iau.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD