History
# Registration date Revision Id
3 2020-08-08, 1399/05/18 165655
2 2013-12-06, 1392/09/15 14018
1
This trial has some update history items in old IRCT format. To see these history items click here.
Changes made to previous revision
This is the first revision

Protocol summary

Summary
This study aimed to investigate the effectiveness of mindfulness based cognitive therapy on improvement of adjustment in hospitalized children with cancer. Entry criteria to study included not receiving psychological therapy for at least one month before participating in the study, having a minimum age of 9 and maximum age of 13 years and staying at least 3 week in hospital. The sample included 33 children with cancer who were randomly assigned to experimental (17 case) and control (16 case) groups. Children in experimental group were trained in 15 sessions of 45 minutes during one month. Findings revealed that mindfulness based cognitive therapy can leads to improvement in children’s psycho-social adjustment in hospitalized children with cancer.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013120614338N1
Registration date: 2013-12-06, 1392/09/15
Registration timing: retrospective

Last update:
Update count: 1
Registration date
2013-12-06, 1392/09/15
Registrant information
Name
Samaneh Abedini
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 33 1274 4183
Email address
sama_abedini@yahoo.com
Recruitment status
Recruitment complete
Funding source
Funded by researcher
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of an Adapted Mindfulness-based Cognitive Therapy for Internalizing and Attention Problems in Children with Cancer
Public title
The Effectiveness of an Adapted Mindfulness-based Cognitive Therapy for Internalizing and Attention Problems in Children with Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having cancer; children; being hospitalized; not receiving psychological therapy for at least one month before participating in the study; patient’s agreement to participate in the research based on informed consent. Exclusion criteria: having brain cancer; children between 9 to 13 ages, being hospitalized less than 3 weeks; receiving psychological therapy for at least one month before participating in the study, patient’s disagreement to participate in the research based on informed consent.
Age
From 9 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 33
Randomization (investigator's opinion)
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
Shahid Beheshti University
Street address
Shahid Beheshti University, Evin, Tehran.
City
Tehran
Postal code
1983963113
Approval date
2013-08-27, 1392/06/05
Ethics committee reference number
58/850/ص

Health conditions studied

1

Description of health condition studied
Adjustment
ICD-10 code
F43.2
ICD-10 code description
Adjustment disorders

Primary outcomes

1

Description
Psychosocial Adjustment
Timepoint
Before and 3 weeks of treatment
Method of measurement
Child Behavior Check List

Secondary outcomes

1

Description
More cooperation in medical treatments
Timepoint
Befor and after of treatment
Method of measurement
Interview

Intervention groups

1

Description
Experimental group: Participants are 17 boys and girls aged 9‐13 that hospitalized because of cancer. They participated in 15-session program consisting of 45-minute group session per week, focused on mindfulness training.
Category
Other

2

Description
Control group: Participants are boys and girls aged 9‐13 (n=16) that hospitalized because of cancer with medical cancer treatment as usual.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahak Hospital and Rehabilitation Complex
Full name of responsible person
Shima Shirafkan
Street address
MAHAK Highly specialized Pediatric Cancer Hospital & Research Center, MAHAK Blvd., Shahid Majdi Blvd., Artesh Freeway, Tehran - Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Mojtaba Habibi (P.H.D)
Street address
Shahid Beheshti University, Evin, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Mojtaba Habibi
Position
P.H.D
Other areas of specialty/work
Street address
Shahid Beheshti University, Evin, Tehran.
City
Tehran
Postal code
Phone
+98 33 1274 4183
Fax
Email
babakhabibius@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Mojtaba Habibi
Position
P.H.D
Other areas of specialty/work
Street address
Shahid Beheshti University, Tehran, Evin
City
Tehran
Postal code
Phone
+98 33 1274 4183
Fax
Email
babakhabibius@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti university
Full name of responsible person
Samaneh Abedini
Position
P.H.D
Other areas of specialty/work
Street address
Shahid Beheshti University, Evin, Tehran
City
Tehran
Postal code
Phone
+98 33 1274 4183
Fax
Email
m.dehghani@sbu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...