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Investigating the effectiveness of pain’s cognitive-behavioral therapy and its computerized version in the reduction of pain intensity, depression, anger and anxiety in children with cancer

Protocol summary

Study aim
The Effectiveness of Common Cognitive-behavioral Pain Therapy and its Computerized Version in Reducing Pain Severity, Depression, Anger, and Anxiety in Children with Cancer
Design
The study’s objectives were described to the participants, and written consent was taken from the child’s parents. The selected individuals signed an agreement including the number of sessions and the estimated duration. All the three groups received medical treatment as usual, but the two experimental groups received psychological interventions as a complementary treatment. In addition, at the end of the study, the control group received intervention.
Settings and conduct
To reduce the bias, the data (i.e., a pre-test and a post-test) was collected by a master student of Clinical Psychology, who did not know the aim of the study. The results were analyzed through ManCova, Anova, and T_test by SPSS software, version20.
Participants/Inclusion and exclusion criteria
The population of this study included all patients with cancer who referred to Ahvaz Shahid Baghee Hospital from the beginning of October of 2018 to the end of December 2018. Inclusion criteria of this study: They suffered from one type of cancer; their age ranged from 9 to 12 years, they were literate, and they were fluent in Persian. Exclusion criteria included neurodevelopmental disorders, autism spectrum disorders (according to the diagnosis of a psychiatrist), and a history of seizure.
Intervention groups
The individuals willing to participate in the study were randomly (using the lottery method) assigned to three groups (i.e., conventional Pain Cognitive- behavior Therapy, computerized Pain Cognitive- behavior Therapy, and control group).
Main outcome variables
Pain,Children, Psychological intervention, Cancer, Anger, Anxiety, Depression.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191225045896N1
Registration date: 2020-05-18, 1399/02/29
Registration timing: retrospective

Last update: 2020-05-18, 1399/02/29
Update count: 0
Registration date
2020-05-18, 1399/02/29
Registrant information
Name
Vajiheh Hamedi
Name of organization / entity
Shahid chamran university
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 6848
Email address
v.hamedi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-07, 1396/10/17
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
2018-01-07, 1396/10/17
Actual recruitment end date
2018-02-19, 1396/11/30
Trial completion date
2018-02-19, 1396/11/30
Scientific title
Investigating the effectiveness of pain’s cognitive-behavioral therapy and its computerized version in the reduction of pain intensity, depression, anger and anxiety in children with cancer
Public title
Investigating the effectiveness of pain’s cognitive-behavioral therapy and its computerized version in the reduction of pain intensity, depression, anger and anxiety in children with cancer.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
They were 9-12 years old. They were literate They had one type of cancer. They were fluentluency in Persian.
Exclusion criteria:
They had neuro-developmental disorders They had autism spectrum disorders (according to the diagnosis of a psychiatrist). They had a history of seizure.
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 50
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The Participants were not aware of the type of intervention of other groups, and the aim objective of the study. The Intervention’s evaluators did not know the purpose of the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee for Research in Ahvaz Jundishapur University
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-01-06, 1396/10/16
Ethics committee reference number
IR.AJUMS.REC.1396.820

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
ICD-10 code description

2

Description of health condition studied
َAnxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

3

Description of health condition studied
Depression
ICD-10 code
ICD-10 code description

4

Description of health condition studied
Anger
ICD-10 code
R45.4
ICD-10 code description
Irritability and anger

5

Description of health condition studied
Pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain

Primary outcomes

1

Description
Pain score in Jung and Baker's scale
Timepoint
Before the intervention, the last session of the intervention, one month after the intervention
Method of measurement
Jung and Baker's pain scale

2

Description
Spilberger's State -Trait Anxiety Scale
Timepoint
Before the intervention, the last session of the intervention, one month after the intervention
Method of measurement
Spilberger's State -Trait Anxiety Scale

3

Description
Children's Depression Inventory Score
Timepoint
Before the intervention, the last session of the intervention, one month after the intervention
Method of measurement
Children's Depression Inventory

4

Description
Spilberger's State-Trait-Anger Expression Inventory score
Timepoint
Before the intervention, the last session of the intervention, one month after the intervention
Method of measurement
Spilberger's State-Trait-Anger Expression Inventory

Secondary outcomes

empty

Intervention groups

1

Description
The first experimental group: Six sessions of cognitive-behavioral therapy in terms of private sessions for each participant were held weekly. The first session included a review of the rules of the meetings (i.e., the principle of anonymity, timely attendance, and assignments), cancer education tutorials and changes which cancer has made in the activities, the introduction of a sensory thermometer to measure the degree of emotion, the introduction to the meetings’ processes and the skills which were to be learned ,next session’s assignments, and the last part of the session which was a fun activity with the therapist. The second session included the review of the assignments the investigation of the challenges and possible problems, introducing Pain Gate Control Theory and the factors which help closing the pain gates, abdominal breathing exercises, relaxation exercises, next session’s assignments, and the last part of the session which was a Pleasurable activity with the therapist. The third session included the review of the assignments, statements on the relationships of thought, feeling, behavior and cognitive errors, positive self-esteem and cognitive reconstructions, reinforcement and self-rewarding, the subsequent session’s homework, the last part of the session which was performing a fun activity. The fourth section included The review of the challenges, problem solving training, attention deviation strategies training, positive mental imagery, countdown), next session’s assignments, and the last part of the session which was doing a fun activity. The fifth session included the review of the assignment, anger control, effective communication training, and next session’s assignment. The last part of the session which was doing one pleasant activity with the therapist. The sixth session included reviewing the pre-treatment task, activating the behavior, presenting the instruction booklet, and a summary of the practical treatment tips, and doing a fun activity with the therapist as the final part of the session.
Category
Behavior

2

Description
The second experimental group’s intervention included using computer training software and performing its tasks on a weekly basis. This version included a compact disc (including 6 sessions) and a parents’ manual and handbook designed as a computer program. The program is a computer program consisting of educational materials which are in accordance with the educational content similar to in-person intervention designed based on prior research. The program was designed and developed by the researchers. The program includes sections on psycho-education, animation, and computer games. The participant inserted the CD into the computer or laptop and then observed the contents of each session according to the instructions in the manual. At the beginning of the program, a list of sessions was specified on the page where they could see the content of that meeting by clicking on the icon of each session. Meanwhile, they performed a series of assignments in the booklet. At the end of each session, after viewing the training material and performing the assignments, the student could play one or more computer games on his/ her own choice. In the computer version, all of the above mentioned materials were provided as an educational program in the form of animation with a manual. Each week the participants observed a part of the program and performed the exercises related to that part.
Category
Behavior

3

Description
The control group: They received no intervention. However, at the end of the treatment sessions of the experimental groups, the control group received the computer program for ethical considerations.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Baghaei 2 Ahvaz Hospital
Full name of responsible person
Bijan Keikhaei Dehdezi
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3375 0410
Email
info@ajums.ac.ir
Web page address
https://h-baghaei2.ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Ibrahim Haji Dolu
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
1939714956
Phone
+98 61 3333 0019
Email
Public@scu.ac.ir
Web page address
http://scu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Chamran University of Ahvaz
Proportion provided by this source
50
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
Shahid Chamran University of Ahvaz
Full name of responsible person
Vajihe Hamedi
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.385, Shahid Kolahdoz(Dolat)Ave,
City
Tehran
Province
Tehran
Postal code
1939714956
Phone
+98 21 2264 6848
Email
v.hamedi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Vajiheh Hamedi
Position
Phd Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No.385, Shahid Kolahdoz (Dolat) Ave,
City
Tehran
Province
Tehran
Postal code
1939714956
Phone
+98 21 2264 6848
Email
v.hamedi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Vajihe Hamedi
Position
Phd Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 385, Shahid Kolahdoz(Dolat) Ave.
City
Tehran
Province
Tehran
Postal code
1939714956
Phone
+98 21 2264 6848
Email
v.hamedi@gmail.com

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
Research colleagues disagree
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The protocol and informed consent form are published in the form of a thesis and a copy of it is available to researchers at Iran Documentation Center, Iran Duck.
When the data will become available and for how long
The following information is available after the date of defense October 2018).
To whom data/document is available
Researchers, Students
Under which criteria data/document could be used
Any scientific use without commercial purpose is permitted.
From where data/document is obtainable
You can access the following information by visiting the university, Iran Duck website or the National Library.
What processes are involved for a request to access data/document
It is sufficient to use a university or student ID card to use the university version. For Access to the National Library version, the membership in the library is required. Membership and payment are required to access the site version of Iran Duck.
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