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The effects of recreational therapy on the quality of life of elderly war victims: a two-group randomized controlled trial

Protocol summary

Study aim
assess the effects of recreational therapy on quality of life among Iranian elderly war victims
Design
Parallel group randomized clinical trial was conducted in 2018 in a war victim’s home in Tehran, Iran. With a power of 0.90 and a confidence level of 0.95, sample size was estimated to be 32 for each group.Participants were conveniently selected and randomly assigned to control and intervention groups via the block randomization method .
Settings and conduct
This parallel group randomized clinical trial was conducted in a war victim’s home in Tehran, Iran. Data were collected via a demographic questionnaire and the Short Form (36) Health Survey (SF-36). SF-36 was completed by each participant thrice, i.e. before, immediately after, and two weeks after the intervention
Participants/Inclusion and exclusion criteria
age of sixty or more, the ability to communicate verbally, no acute physical pain, no participation in similar recreation therapy programs, willingness to participate in the study, and no serious health problem which could prevent participation in recreational activities. Participants were excluded if they developed severe physical or mental problem during the study
Intervention groups
The intervention group ten ninety-minute sculpturing sessions, ten sixty-minute sessions for listening to a favorite music, ten thirty-minute relaxation sessions, ten 45-minute physical exercise sessions, and two daily trips and routin care were performed. These sessions were held in ten successive weeks. the control group just received routine care.
Main outcome variables
Improving the quality of life, preventing the progression of the disease and reaching the stage of disability, improving the capabilities of veterans, preventing the occurrence and occurrence of chronic diseases, maintaining independence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201006048946N1
Registration date: 2020-10-25, 1399/08/04
Registration timing: retrospective

Last update: 2020-10-25, 1399/08/04
Update count: 0
Registration date
2020-10-25, 1399/08/04
Registrant information
Name
Maryam Pakseresht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3333 2068
Email address
pakseresht-m@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
2020-06-21, 1399/04/01
Actual recruitment end date
2020-09-22, 1399/07/01
Trial completion date
2020-10-06, 1399/07/15
Scientific title
The effects of recreational therapy on the quality of life of elderly war victims: a two-group randomized controlled trial
Public title
The effects of recreational therapy on the quality of life of elderly war victims
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age of sixty or more The ability to communicate verbally No participation in similar recreation therapy programs Willingness to participate in the study No acute physical pain, No serious health problem which could prevent participation in recreational activities
Exclusion criteria:
severe physical or mental problem
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Actual sample size reached: 63
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were conveniently selected and randomly assigned to control and intervention groups via the block randomization 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 Baqiyatallah University of Medical Sciences
Street address
Arsham Complex 2. Third floor,. Azadegan St., Chamran St., Khorramrudi Boulevard
City
Ilam
Province
Ilam
Postal code
paksereshtmaryam@yah
Approval date
2016-04-26, 1395/02/07
Ethics committee reference number
Ir.bmsu.rec.1395.207

Health conditions studied

1

Description of health condition studied
War victim, Elderly
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
War victim quality of life
Timepoint
Short Form (36) Health Survey (SF-36) was completed by each participant thrice, i.e. before, immediately after, and two weeks after the intervention
Method of measurement
Data were collected via a demographic questionnaire and the Short Form (36) Health Survey (SF-36). The items of the demographic questionnaire were age, gender, educational status, and previous history of hospitalization. Short Form (36) Health Survey (SF-36) is a self-administered survey with 36 items in the following eight dimensions: physical functioning (ten items), role limitations due to physical health problems (four items), bodily pain (two items), general health (five items), energy/fatigue (four items), social functioning (two items), role limitation due to emotional problems (three items), emotional well-being (five items), and a non-categorized single item. Items are scored from 0 to 100. Higher scores represent higher QOL. SF-36 can be completed in 5–10 minutes

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants in the intervention group were provided with both recreational therapy and routine care services of the study setting. recreational therapy consisted of ten ninety-minute sculpturing sessions, ten sixty-minute sessions for listening to a favorite music, ten thirty-minute relaxation sessions, ten 45-minute physical exercise sessions, and two daily trips.
Category
Lifestyle

2

Description
Control group: Participants in the control group just received routine care services of the study setting
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Sarallah war victim’s home
Full name of responsible person
Maryam Pakseresht
Street address
3rd floor,.Arsham apartment 2., Azadegan St.,Chamran St.,Khorramrudi Boulevard
City
Ilam
Province
Ilam
Postal code
6931433894
Phone
+98 84 3333 2068
Email
paksereshtmaryam@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Salman Barasteh
Street address
No. 485,. Jomhory St., South Eskandari St., dead end of haft dastgah
City
Tehran
Province
Tehran
Postal code
1319846951
Phone
+98 21 6686 4257
Email
s.barasteh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
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
Ilam University of Medical Sciences
Full name of responsible person
Maryam Pakseresht
Position
Nursing Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arsham Apartment 2, 3rd floor,. Boulevard, Chamran St., Azadegan St.
City
Ilam
Province
Ilam
Postal code
6931433894
Phone
+98 84 3333 2068
Email
paksereshtmaryam@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Maryam Pakseresht
Position
Nursing Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arsham Apartment 2, 3rd floor,. Boulevard, Chamran St., Azadegan St.,
City
Ilam
Province
Ilam
Postal code
6931433894
Phone
+98 84 3333 2068
Email
paksereshtmaryam@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Maryam Pakseresht
Position
Nursing Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arsham Apartment 2, 3rd floor,. Boulevard, Chamran St., Azadegan St.,
City
Ilam
Province
Ilam
Postal code
6931433894
Phone
+98 84 3333 2068
Email
paksereshtmaryam@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
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