The effect of life review intervention on relationship quality and quality of life in rural elderly widows in Bojnourd city, North Khorasan province
Design
This trial has two control and intervention groups, with parallel groups, no blinding, randomized, will be performed on 132 elderly rural widows. Excel software rand function will be used for randomization.
Settings and conduct
From these centers, two centers will be selected due to the similarity of dialect and culture and the distance of the villages from the city of Bojnourd, which have relatively similar conditions. And one of the centers is designated as the intervention group and the other as the control.
Participants/Inclusion and exclusion criteria
1- Age over 60 years old 2- At least one year has passed since the time of widowhood.3- A maximum of 20 years have passed since their widowhood.4- Willingness to participate in study (reminiscence sessions). 5 - The ability to communicate
Intervention groups
Intervention group: life review, which will be performed during 6 sessions for 6 weeks. During the sessions, photos, music and old equipment will be used to stimulate memory. Control group: No intervention (after the study, the training of the intervention group will be provided briefly for them in two sessions).
Main outcome variables
Quality of life - quality of relationships
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111017007816N18
Registration date:2020-10-29, 1399/08/08
Registration timing:registered_while_recruiting
Last update:2020-10-29, 1399/08/08
Update count:0
Registration date
2020-10-29, 1399/08/08
Registrant information
Name
Mahin Nazari
Name of organization / entity
School of health
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
manazari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-11, 1399/07/20
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of life review intervention on relationship quality and quality of life in rural elderly widows in Bojnourd city, North Khorasan province
Public title
The effect of life review intervention on relationship quality and quality of life in rural elderly widows in Bojnourd city, North Khorasan province
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Older women over 60
At least one year has passed since my widowhood
A maximum of 20 years have passed since they became widows
Willingness to participate in study (reminiscence sessions)
Ability to communicate
Covered by comprehensive health databases and registered in the Apple system.
Exclusion criteria:
Reluctance to participate in the study
Age
From 60 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
To start the study, the selected rural health centers will be referred and the information of widows over 60 years of age will be examined. Then, according to the inclusion criteria, if the number of people is approximately equal to the sample size, the sensus will be used. But if the number of people is higher than the desired sample size, the random allocation method will be used to select the subjects. In this way, we will write down the national code of the people who have the conditions to enter the study in separate sheets and put them in a container and ask one of the uninformed people present in the health center to select 66 sheets randomly. In the same way, control group will be selected.
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
Shiraz University Of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
7153675541
Approval date
2020-05-13, 1399/02/24
Ethics committee reference number
IR.SUMS.REC.1399.196
Health conditions studied
1
Description of health condition studied
-
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Quality of life scores
Timepoint
Before and two months after the intervention
Method of measurement
Lipad Questionnaire
2
Description
quality of relationships
Timepoint
Before and two months after the intervention
Method of measurement
Relationship Quality
Secondary outcomes
empty
Intervention groups
1
Description
For the intervention group, life review training classes will be held in 6 sessions for 6 weeks. During these sessions, reviewing the late stages of widowhood, reviewing the moments of death of a spouse and how to deal with his or her absence, reviewing ways to deal with the challenges of livelihood, reviewing the training learned to deal with the challenges of widowhood, reviewing current challenges. Due to the prevalence of coronary heart disease, three training sessions will be conducted in person in accordance with health protocols, the other three sessions will be conducted through educational media and the production of educational clips and memorable image clips, as well as telephone interviews.
Category
Behavior
2
Description
No intervention or training was provided for the control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Rural health centers
Full name of responsible person
Dr Bazkhanei
Street address
Hor Street
City
Bojnoord
Province
North Khorasan
Postal code
74586647
Phone
+98 58 3223 0122
Email
N.Pirzadeh7238@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahin Nazari
Street address
School of public Health, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1005
Email
manazari@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Nasim Pirzadeh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
Hor Street
City
Bojnoord
Province
North Khorasan
Postal code
7458686785
Phone
0583545448
Email
N.pirzadeh7238@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahin Nazari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of health Education and promotion, School of public Health, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1005
Email
manazari@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasim Pirzadeh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
Hor Street
City
Bojnoord
Province
North Khorasan
Postal code
74586859575
Phone
+98 58 3323 5484
Email
N.pirzaeh7238@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
The total number of people referring to the magazine in which the article was published
Under which criteria data/document could be used
Supervisor
From where data/document is obtainable
Dr. Mahin Nazari Email manazari@sums.ac.ir
What processes are involved for a request to access data/document
The coordinators author takes about 1 week to 1 month