Determining the effect of Art therapy on quality of life in elderly women
Design
Clinical trial with intervention and control group with parallel groups, two-way randomized blind, phase 76 patients, Online random allocation.
Settings and conduct
The study population will be elderly women referring to comprehensive health centers in East Gilan who meet the inclusion criteria. First, the samples that meet the criteria for entering the study will be selected using the available sampling method, and if they wish to participate in the study of the quality of life scale of the elderly Lipad, 76 people will be selected as a sample and randomly in the group and or will be controlled. Art therapy will be applied to the experimental group in 4 sessions of 90 minutes. During this period, no art therapy services will be provided for the control group. At the end of the fourth session, the quality of life intervention questionnaire will be completed by the participants in the intervention group and simultaneously by the control group. 8 weeks after the end of the intervention, the quality of life questionnaire will be completed again by both groups.
Participants/Inclusion and exclusion criteria
Elderly women 60 years old and over 60 years old, Willingness to participate in research, Being literate in reading and writing.
Intervention groups
For the intervention group, 4 sessions of 90 minutes (one session per week for one month) of art therapy will be held. During this time, no art therapy services will be provided to the control group.
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220401054380N1
Registration date:2025-02-11, 1403/11/23
Registration timing:prospective
Last update:2025-02-11, 1403/11/23
Update count:0
Registration date
2025-02-11, 1403/11/23
Registrant information
Name
Fatemeh Najafzadehshavaki
Name of organization / entity
The East Guilan School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 13 4262 0549
Email address
najafzade.fateme.7726@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Art therapy on quality of life in elderly women : A randomized controlled trial
Public title
The effect of Art therapy on quality of life in elderly women : A randomized controlled trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly women 60 years old and over 60 years old
Willingness to participate in research
Being literate in reading and writing
Exclusion criteria:
Age
From 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the daily visits of the elderly, they are called to the center and if they meet the inclusion criteria, they will be included in the study. Based on four random blocks, the sequence of which will be obtained through the online random allocation software, into two groups A (art therapy) (and group B) random allocation control. According to the sample size in two groups (n = 76) (19), there will be four random blocks in the random allocation sequence. The list of blocks sequence is placed in the envelope in the package. After the permission from the research vice-chancellor, it is read daily during the implementation of the study.
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 Guilan University of Medical Sciences
Street address
Ibn Sina Street, Faculty of Nursing, Midwifery and Para medicine, East Guilan
City
Langrud
Province
Guilan
Postal code
4477166595
Approval date
2024-11-13, 1403/08/23
Ethics committee reference number
IR.GUMS.REC.1403.364
Health conditions studied
1
Description of health condition studied
quality of life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life score in LEIPAD quality of life questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and immediately after the end of the intervention and 8 weeks after the end of the intervention
Method of measurement
LEIPAD quality of life questionnaire
Secondary outcomes
1
Description
Quality of life score in LEIPAD quality of life questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and immediately after the end of the intervention and 8 weeks after the end of the intervention
Method of measurement
LEIPAD quality of life questionnaire
Intervention groups
1
Description
Intervention group: In each art therapy session, the intervention group supervises the implementation of each participant by explaining the working method in that session. The contents of the sessions are implemented through the use of different arts in a way that promotes relaxation and introspection and mental imagery of a situation. In which the person is located and to create a connection of emotions in people. In the welcome session, the sessions are conducted by the trainer. The warm-up exercise is to create relaxation and prepare people to enter the main exercise (each session). This initial exercise is planned by creating visualization for people for the main exercise that is aimed at describing the beginning of each situation or its solutions. Then, the practice of each session is done according to the content of that session by using accessible and low-cost art tools in a way that can put the person in the current mental state. After each exercise, people are asked to express their feelings and then The instructor will help each person to understand his art product. At the end of each session, the participants will take their artwork home. At the end of each session, they will practice relaxation using music and mental imagery to be in a pleasant atmosphere. It is done along with breathing exercises. On average, the warm-up, relaxation and guided imagery phase will take 7-10 minutes; The stage of artistic output will last 60 minutes and the stage of verbal development will take 15 to 20 minutes. Table 1. Content, purpose and time of art therapy sessions. Construction of the current situation of the exercise: relaxation, listening to silent music and relaxation, the purpose of introducing and getting to know the people of the group, self-expression, time: 10 minutes, the second session, warming up the color spot, exercise: the main full-length picture, painting the worst fears and threatening situations, relaxation exercise, closing the eyes and imagining A calming place, the purpose of expressing anger, fear: time 90 minutes, the third session, warm exercise: making contrasting colors, lines and shapes, exercise: main envelope and: face painting box, make yourself a symbol of your talents or capabilities by drawing or collage drawing a circle of support and relaxation table, relaxation exercise, looking at the mirror and self-love, a valuable goal, ability, support, time 90 minutes, the fourth session, warm-up exercise, making your own symbol with clay, the main exercise of making seasons with clay, making a nest tree, a bird, and a storm-stricken tree, writing a letter to God and a letter to his wife, practicing calming breathing and gratitude music: purpose, vision, solution, hope and future, time 90 minutes.
Category
Rehabilitation
2
Description
Control group: During this period, no art therapy services will be provided for the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Center No. 2 of Rudsar city
Full name of responsible person
Mohammad Zamani
Street address
Heshmat Hospital, Revolution st
City
Rudsar
Province
Guilan
Postal code
4193713111
Phone
+98 13 4261 3551
Email
riasat@gums.ac.ir
2
Recruitment center
Name of recruitment center
Comprehensive Health Center No. 3 of Rudsar city
Full name of responsible person
Mohammad Zamani
Street address
Nasehi St. between Shahid Gutari and Shahid Square
City
Rudsar
Province
Guilan
Postal code
4193713111
Phone
+98 13 4262 4556
Email
riasat@gums.ac.ir
3
Recruitment center
Name of recruitment center
Comprehensive Health Center No. 3 of Lahijan city
Full name of responsible person
Seyed ali zaker nagibi
Street address
Lahijan, Imam khomeini East, 22 Aban Hospital.
City
Lahijan
Province
Guilan
Postal code
4193713111
Phone
+98 13 4223 3078
Email
riasat@gums.ac.ir
4
Recruitment center
Name of recruitment center
Comprehensive Health Center of Lialistan
Full name of responsible person
Avishan Vahdatirad
Street address
Lahijan, Lialistan village.
City
Lahijan
Province
Guilan
Postal code
4193713111
Phone
+98 13 4236 8147
Email
riasat@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
Namjo St, Shahid Siyadati St, in front of 17 Shahrivar Hospital
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Fatemeh Najafzadeh Shavaki
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 80, Abbaspur Alley, 72 Tan St
City
Rudsar
Province
Guilan
Postal code
4481834596
Phone
+98 13 4262 0549
Email
najafzade.fateme.7726@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Fatemeh Najafzadeh Shavaki
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 80, Abbaspur Alley, 72 Tan St
City
Rudsar
Province
Guilan
Postal code
4481834596
Phone
+98 13 4262 0549
Email
najafzade.fateme.7726@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Fatemeh Najafzadeh Shavaki
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 80, Abbaspur Alley, 72 Tan St
City
Rudsar
Province
Guilan
Postal code
4481834596
Phone
+98 13 4262 0549
Email
najafzade.fateme.7726@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
All potential data can be shared after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
All researchers in academic and scientific institutions will be able to use and analyze the data and results of the study for their future research.
From where data/document is obtainable
The receive data, refer to the email address below:
najafzade.fateme.7726@gmail.com
What processes are involved for a request to access data/document
The applicant must send a valid certificate for his employment in academic and scientific institutions to the relevant email, and if the information is valid, the data will be emailed to him within a maximum of one month.