The effect of play-based occupational therapy on symptoms and participation in activities of daily living of hospitalized children with cancer receiving chemotherapy
Objectives: To investigate of the effect of play-based occupational therapy on activity of daily living and therapy related symptoms of hospitalized children receiving chemotherapy. Design: 25 children (7-12 years) with cancer receiving chemotherapy in Aliasghar hospital allocated randomized in 2 groups. Setting: Intervention group received 8 sessions (30 minutes) of play-based occupational therapy. Participants: 7-12 years children with cancer receiving inpatient chemotherapy, and parent with literacy ability (pesian). Main outcome measures: Acitivity of daily living & therapy related symptoms as main outcome measures, pain, fatigue & anxiety as secondary outcome measures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080829260N1
Registration date:2016-09-12, 1395/06/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-12, 1395/06/22
Registrant information
Name
Afsson Hassani Mehraban
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22227124
Email address
mehraban.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of play-based occupational therapy on symptoms and participation in activities of daily living of hospitalized children with cancer receiving chemotherapy
Public title
The effect of play-based occupational therapy on symptoms and participation in activities of daily living of hospitalized children with cancer receiving chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Childhood cancer diagnosis; receiving at least one inpatient chemotherapy period; 4 scores in pain (faces pain scale) and fatigue (visual fatigue scale) scales or 3 in anxiety (faces anxiety scale) scale; parents with literature abilities (persian)
Exclusion criteria: Any change in chemotherapy protocol; denying participation up to 2 sessions; other medical 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:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Iran University of Medical Sciences
Street address
Hemmat highway
City
Tehran
Postal code
-
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
ir.iums.rec.1395.9211525210
Health conditions studied
1
Description of health condition studied
Neoplasms
ICD-10 code
C00-C75
ICD-10 code description
Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue
Primary outcomes
1
Description
Therapy related symptoms
Timepoint
1. pretreatment 2. after phase 1 treatment (session 4) 3. after discharge (session 8)
Method of measurement
Therapy Related Symptom Checklist (TRSC)
2
Description
Participation in activity of daily living
Timepoint
1. pretreatment 2. after phase 1 treatment (session 4) 3. after discharge (session 8)
Method of measurement
Iranian Children Participation Questionnaire (ICPQ)