Determining the effect of designed Leisure time intervention on loneliness and general health in widows elderly
Design
This study is a clinical trial. The population of this study included 64 elderly widows over 60 years old who were referred to health centers of Jiroft. Individuals were selected according to inclusion criteria and then randomly divided into two intervention and control groups.
Settings and conduct
In this study, 64 women were selected from among widows elderly referred to health centers of Jiroft and then randomly divided into two intervention and control groups. Intervention consisted of 8 sessions of Leisure time program during 4 weeks which were held for the intervention group in kasra welfare complex of jiroft. Loneliness and general health were measured in both groups before and two weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Being widow; Age over 60; Home inhabitant; Non-alcohol and drug addiction; Absence of stressful events in the last 6 months; Ability to communicate verbally; No acute underlying disease and severe pain; No participation in Same programs; Ability to do daily activities; The desire to participate in the study
Intervention groups
People were divided into two intervention and control groups by plain randomized method. First, a Pretest was done in both groups, Then the designed leisure time intervention in the intervention group was done for four weeks, two times a week, each time two hours. Sessions was done according to a schedule set. The control group received no intervention. The post test was done two weeks after intervention in both groups.
Main outcome variables
Loneliness; General Health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180513039627N1
Registration date:2018-07-14, 1397/04/23
Registration timing:retrospective
Last update:2018-07-14, 1397/04/23
Update count:0
Registration date
2018-07-14, 1397/04/23
Registrant information
Name
Rehimeh Izadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
pazhoohesh@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-06, 1396/05/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of designed Leisure time Intervention on Loneliness and General Health in Widows Elderly
Public title
The Impact of designed Leisure time Intervention on Loneliness and General Health in Widows Elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being widow
Age over 60
Home inhabitant
Non-alcohol and drug addiction
Absence of stressful events in the last 6 months
Ability to communicate verbally
No acute underlying disease and severe pain
No participation in Same programs
Ability to do daily activities
The desire to participate in the study
Exclusion criteria:
Age
From 60 years old to 90 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The peoples were divided into two intervention and control groups with simple randomization method (lottery).
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 Rafsanjan University of Medical Sciences
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2017-07-31, 1396/05/09
Ethics committee reference number
IR.RUMS.REC.1396.82
Health conditions studied
1
Description of health condition studied
Loneliness
ICD-10 code
ICD-10 code description
2
Description of health condition studied
General Health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Loneliness
Timepoint
Before intervention and two weeks after the end of intervention
Method of measurement
Loneliness Questionnaire (UCLA)
2
Description
General Health
Timepoint
Before intervention and two weeks after the end of intervention
Method of measurement
General Health Questionnaire (GHQ-28)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention included 8 sessions of designed leisure time program during 4 weeks, two times a week, each session was for two hours.The intervention group became divided to two groups of 16 members. Sessions was done according to a schedule set. This program was consisted of activities like: sports activities( walking), artistic(handcraft), religious(Prayer), educational(nutrition, health, aging mobility exercises, social connections), reminiscence, expression of life experiences, expression of emotions and feelings, control blood sugar and blood pressure and Weight.
Category
Lifestyle
2
Description
Control group: No intervention was done in this group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health care centers in Jiroft city
Full name of responsible person
Dr Majid Kazemi
Street address
Faculty of Nursing and Midwifery, Jomhori Blvd, Rafsanjan,Iran
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
Maj_kaz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3425 5900
Email
dr.kazemi.n@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Position
Phd
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3425 5900
Email
dr.kazemi.n@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Position
Phd
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3425 5900
Email
dr.kazemi.n@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Rahimeh Izadi
Position
Master Student of Geriatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3425 5900
Email
izadi.rahimeh@gmail.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