The Clinical Trial of Acceptance and Commitment Therapy (CHACT) on the Psychological Flexibility in Pain, Function, Quality of life, Internalizing and Externalizing Symptoms of 7 to 12 years - old Children with Chronic Pain
According to the criteria of chronic pain and other inclusion criteria such as being in the range age of 7 to 12 and earning a score of 13 to 29 in the Function Disability Inventory, 20 children who according to their parents were prepared to participate in this study, were selected from specialized and subspecialty pediatric hospitals of Tehran. In this study, due to small sample size, sampling method was based on available method. Then, the children were placed in the experimental group (n = 10) and control group (n = 10). The child and parent versions of Function Disability Inventory, the Psychological Inflexibility in Pain Scale and also KID Screen and Child Behavior Checklist was administered on both groups at pretest, post test, the first follow-up (1.5 months after the treatment) and the second follow-up (5.5 months after the treatment).
General information
Acronym
CHACT
IRCT registration information
IRCT registration number:IRCT2013112815577N1
Registration date:2014-04-06, 1393/01/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-06, 1393/01/17
Registrant information
Name
Soheila Ghomian
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 3627 0702
Email address
ghomian_s@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-06-19, 1391/03/30
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Clinical Trial of Acceptance and Commitment Therapy (CHACT) on the Psychological Flexibility in Pain, Function, Quality of life, Internalizing and Externalizing Symptoms of 7 to 12 years - old Children with Chronic Pain
Public title
The Effectiveness of Acceptance and Commitment Therapy on Chronic Pain of Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being in the age range of 7 to 12; Engagement with education; Obtain a score of 13 to 29 (moderate disability) in Function Disability Inventory (FDI); A history of developing chronic pain for 6 months or more and at least 3 months of the first medical treatment in relation to chronic pain according to viewpoint of physician; the ability to attend meetings according to confirmation of physician.
Exclusion criteria: Absence of the above conditions.
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Department of education and graduate, Shahed University
Street address
Shahed University, In front of shrine, Persian Gulf Freeway, Tehran, Iran
City
Tehran
Postal code
.....
Approval date
2012-10-29, 1391/08/08
Ethics committee reference number
130/23217
Health conditions studied
1
Description of health condition studied
Chronic pain
ICD-10 code
R52.1
ICD-10 code description
Chronic intractable pain
Primary outcomes
1
Description
Psychological flexibility in Pain
Timepoint
Before the treatment, after the treatment, first follow-up (1.5 month after the treatment) and second follow-up( 5.5 month after the treatment)
Method of measurement
Psychological Inflexibility in Pain Scale (PIPS)
Secondary outcomes
1
Description
Function
Timepoint
Before the treatment, after the treatment, first follow-up (1.5 month after the treatment)and second follow-up(5.5 month after the treatment)
Method of measurement
Function Disability Inventory (FDI)
2
Description
Quality of life
Timepoint
Before treatment, after treatment, first follow-up (1.5 month after treatment)and second follow-up(5.5 month after treatment
Method of measurement
The Health-Related Quality of Life KIDSCREEN- 27 Questionnaire
3
Description
Internalizing and Externalizing Symptoms
Timepoint
Before the treatment, after the treatment, first follow-up (1.5 month after the treatment)and second follow-up(5.5 month after the treatment
Method of measurement
Child Behavior Check List (CBCL)
Intervention groups
1
Description
Experimental group: The designed protocol of CHACT was individually implemented for 8 sessions (each session is about one hour) on them. For protocol design, on one hand, the resources associated with acceptance and commitment therapy and psychological therapy for children, and the other hand, the initial version of acceptance and commitment therapy on children ( To consult with Association for Contextual Behavioral Science (ACBS)), were used. The basic components of this protocol include acceptance, cognitive defusion, valuing, behavioral commitment, etc. The objective of the acceptance is that patients are encouraged to welcome unsolicited thoughts and feelings. Thus, there is a way to change avoiding from painful situations. The goal of cognitive defusion is reduction in the true sense of inner experiences. That, thoughts should be considered only as thought and reduced their impact on behavior. In this treatment, the values are considered as elements of life and they stimulate the patients to engage in some specific activity. The patients learn to determine their value orientations in different aspects ( Eg, family, spirituality ) and act in accordance with them. The behavioral commitments lead to realize the values. they will continue until in person be made the great models of flexible and effective behaviors that are associated with the values.
It should be noted that at the end of each session, in accordance with the content of the protocol, a 20-minute session is considered for children`s parent.
Category
Behavior
2
Description
Control group: They received conventional medical treatment in the hospitals
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children`s Hospital
Full name of responsible person
Soheila Ghomian
Street address
Mofid Children`s Hospital, Before Mirdamad Street, Above Hosseiniye Ershad, Doctor Ali Shariati Street, Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Soheila Ghomian
Street address
Children's Medical Center, No. 62, Next to Imam Khomeini Hospital, Doctor Mohamed Gharib Street, Keshavarz Blvd, Tehran, Iran
City
Tehran
3
Recruitment center
Name of recruitment center
Hazrate Ali Asghar Children's Hospital
Full name of responsible person
Soheila Ghomian
Street address
Hazrate Ali Asghar Children's Hospital, Shahid Dastgerdi Street (Zafar), Tehran, Iran