History
# Registration date Revision Id
2 2020-09-23, 1399/07/02 152230
1 2018-01-02, 1396/10/12 31722
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
determination of the Effect of Group play Therapy on Depression and Loneliness in the Elderly
Design
This study was a clinical trial study. The population of this study was 60 elderly patients aged 60 years and older who were referred to Daneshamooz and Sadaf health centers in Mashhad. Individuals based on the goal will be included in the study, then Then randomly and based on the Random numbers Divided In both intervention and control groups. Pre-test is done in both groups then play therapy sessions are conducted in the intervention group in 12 sessions.
Settings and conduct
The location of the study is two health centers that named Daneshamooz and Sadaf.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 60 and above; willingness to participate in the study; written consent for participation in the research; ability to communicate with the researcher; Obtaining a score of at least 7 from a short-cognitive questionnaire; lack of visual and hearing impairment to an extent that causes activity impairment; non-use of antidepressants during the study; absence of acute and chronic disabling diseases such as kidney disease, cancer, and insufficiency Heart failure and lack of mental disorders; minimal depression (obtaining a score of at least 5 from the depression scale of the elderly); feeling lonely (obtaining a score of at least 21 from the loneliness scale. Exclusion criteria: Refuse to participate in the study and collaborate with the researcher; Missing more than 3 sessions at meetings; The deaths of research units; Acute illness or hospitalization during the study.
Intervention groups
The subjects were randomly assigned to control and intervention groups. Pre-test is done in both groups, Then the play therapy sessions in the intervention group are 12 sessions and 2 sessions per hour each week. members are organized in groups and groups of 10 people.play therapy interventions organized by a researcher who has previously received the necessary certification under the supervision of a play specialist. The control group uses the central service (Organizing Senior Education Classes; Domestic doctor and general practitioner visits routinely and periodically; Perform periodic laboratory test; Perform specialist Psychological actions and all other services provided by the health center) of the center. After the end of the intervention, post-test is done in both groups.
Main outcome variables
Depression Loneliness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170619034650N1
Registration date: 2018-01-02, 1396/10/12
Registration timing: retrospective

Last update: 2018-01-02, 1396/10/12
Update count: 1
Registration date
2018-01-02, 1396/10/12
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3621 3673
Email address
jameif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-27, 1396/09/06
Expected recruitment end date
2017-12-06, 1396/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of group play therapy on depression and loneliness among the elderly
Public title
The Effect of group play therapy on depression and loneliness among the elderly
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria:: Age 60 and above; willingness to participate in the study; written consent for participation in the research; ability to communicate with the researcher; Obtaining a score of at least 7 from a short-cognitive questionnaire; lack of visual and hearing impairment to an extent that causes activity impairment; non-use of antidepressants during the study; absence of acute and chronic disabling diseases such as kidney disease, cancer, and insufficiency Heart failure and lack of mental disorders; minimal depression (obtaining a score of at least 5 from the depression scale of the elderly); feeling lonely (obtaining a score of at least 21 from the loneliness scale.
Exclusion criteria:
Exclusion criteria: Refuse to participate in the study and collaborate with the researcher; Missing more than 3 sessions at meetings; The deaths of research units; Acute illness or hospitalization during the study.
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals based on the goal will be included in the study, then Then randomly and based on the Random numbers Divided In both intervention and control groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The games in the study are under the supervision of a game therapist

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhsd, End of Shahid Fakvari Boulevard, between Shahid Javan Square and Shahid Al-Shahidi square, Health Science Township
City
mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Approval date
2017-11-23, 1396/09/02
Ethics committee reference number
IR.MUMS.REC.1396.248

Health conditions studied

1

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

2

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

Primary outcomes

1

Description
Depression
Timepoint
Before and after the end of the intervention
Method of measurement
Geriatric depression scale

2

Description
Loneliness
Timepoint
Before and after the end of the intervention
Method of measurement
Loneliness questionnaire (UCLA ver3)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention 1 is as follows: the play therapy sessions in the intervention group are 12 sessions and 2 sessions per hour each week. members are organized in groups and groups of 10 people. The first session is a general introduction and description of the activities, explaining the goals of the research and the duties of each person during the intervention and The next sessions will be based on the scheduled schedule.
Category
Lifestyle

2

Description
Control group: The control group uses the central service (Organizing Senior Education Classes; Domestic doctor and general practitioner visits routinely and periodically; Perform periodic laboratory test; Perform specialist Psychological actions) of the center. No specific action is taken in this group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad No. 1 Health Center
Full name of responsible person
Amini Naser
Street address
Vakil Abad Boulevard, between Vakil Abad 66 and 68, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
000
Phone
+98 51 3501 5080
Fax
+98 51 3501 7420
Email
Aminin1@mums.ac.ir
Web page address
http://fa.irct.ir/user/trial/26436/update/recruitment_center

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Deputy of Research of Mashhad University of Medical Sciences
Street address
Shaheed Fakouri Boulevard, between Shahid Javan Square and Shahid Al-Shahidi Square.Health Science Township, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresearch@mums.ac.ir
Web page address
http://fa.irct.ir/user/trial/26436/update/sponsor
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Jamei fateme
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad University of Medical Sciences, Faculty of Nursing and Midwifery, Daneshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
jameif1@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Jamei fateme
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad University of Medical Sciences, Faculty of Nursing and Midwifery, Daneshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
jameif1@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Jamei fateme
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad University of Medical Sciences, Faculty of Nursing and Midwifery, Daneshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
jameif1@mums.ac.ir
Web page address

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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