The comparison of the effectiveness of well-being therapy and acceptance and commitment therapy on pain coping strategies, psychological well-being, perception and pain self-efficacy among the patients with chronic neuropathic pain
The comparison of the effectiveness of well-being therapy and acceptance and commitment therapy on pain coping strategies, psychological well-being, perception and pain self-efficacy among the patients with chronic neuropathic pain
Design
Clinical trial, with control group, with parallel groups, without blinding, in which 45 patients with chronic neuropathic pain will be randomly assigned to three groups.
Settings and conduct
The study population will be patients aged 25 to 50 years with chronic neuropathic pain referred to the Babol Spiritual Medical Center. They will be assigned to three groups randomly (through lottery).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 25 to 50 years, not taking psychiatric medication during three last month, Diagnosis of chronic neuropathic pain by a neurologist, Minimum diploma education.
Exclusion criteria: Cancer; multiple sclerosis; Alzheimer's disease; Having a mania or a psychiatric disorder
Intervention groups
Intervention group 1: They will receive group training on well-being therapy (well-being therapy) through 8 120-minute sessions.
Intervention group 2: They will receive group training on acceptance and commitment therapy through 8 120-minute sessions.
Control group:This group will not receive any therapeutic interventions. But after the follow-up period, treatment will also be considered for this group.
Main outcome variables
Pain coping strategies, Psychological well-being, Pain perception and Pain self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180607040001N2
Registration date:2022-02-27, 1400/12/08
Registration timing:registered_while_recruiting
Last update:2022-02-27, 1400/12/08
Update count:0
Registration date
2022-02-27, 1400/12/08
Registrant information
Name
Masoumeh Dehestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3222 9146
Email address
stu.dehestani@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of well-being therapy and acceptance and commitment therapy on pain coping strategies, psychological well-being, perception and pain self-efficacy among the patients with chronic neuropathic pain
Public title
The effectiveness of well-being and acceptance-based therapy on coping strategies with pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 25 to 50 years
Not taking psychiatric medication during three last month
Diagnosis of chronic neuropathic pain by a neurologist
Minimum diploma education
Exclusion criteria:
Cancer
Multiple sclerosis
Alzheimer's disease
Having a mania or a psychiatric disorder
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to 3 groups of 15 using simple randomization (by lottery method).
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 Sari Branch
Street address
Islamic Azad University Sari Branch, 7 km from Darya Road, Khazar Square, Sari
City
Sari
Province
Mazandaran
Postal code
4816119318
Approval date
2022-01-23, 1400/11/03
Ethics committee reference number
IR.IAU.SARI.REC.1400.114
Health conditions studied
1
Description of health condition studied
chronic neuropathic pain
ICD-10 code
G62.8
ICD-10 code description
Other specified polyneuropathies
Primary outcomes
1
Description
Pain coping strategies
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Coping Strategies Questionnaire (CSQ)
2
Description
Psychological well-being
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Psychological Well- Being Scale (PWB-18)
3
Description
Pain perception
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Pain Belief and Perception Inventory (PBPI)
4
Description
Pain self-efficacy
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Pain Self- Efficacy Questionnaire (PSEQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: They will receive group training on well-being therapy (well-being therapy) through 8 120-minute sessions.
Category
Behavior
2
Description
Intervention group 2: They will receive group training on acceptance and commitment therapy through 8 120-minute sessions.
Category
Behavior
3
Description
Control group:This group will not receive any therapeutic interventions. But after the follow-up period, treatment will also be considered for this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital of Babol
Full name of responsible person
Masoumeh Dehestani
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
stu.dehestani@iausari.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Mohammad Farsi
Street address
Islamic Azad University Sari Branch, 7 km from Darya Road, Khazar Square, Sari
City
Babol
Province
Mazandaran
Postal code
4816119318
Phone
+98 11 3317 5333
Email
mfarsi2008@gmail.com
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
Masoumeh Dehestani
Position
PhD Student in Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 96 , Edalat 2 alley , Baghban Mahale St. , Modaress St.
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 9146
Email
stu.dehestani@iausari.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Dehestani
Position
PhD Student in Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 96 , Edalat 2 alley , Baghban Mahale St. , Modaress St.
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3222 4691
Email
stu.dehestani@iausari.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Dehestani
Position
PhD Student in Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 96 , Edalat 2 alley , Baghban Mahale St. , Modaress St.
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3222 4691
Email
stu.dehestani@iausari.ac.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
There is still no plan for its publish.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available