Determining the effect of guided imagery on sleep quality and general health of the elderly with sleep problems
Design
Clinical trial with a control group, randomized, with a sample size of 75 people. Randomization by random number table method.
Settings and conduct
or sampling, by referring to one of the health centers of Ardabil city, 70 elderly people will be selected by the available method to enter the study. Then samples will be randomly divided into two groups of 35 people (intervention and control).
Participants/Inclusion and exclusion criteria
- Men and women 60 years and older
- A score of 5 or higher on the Pittsburgh Sleep Quality Questionnaire
- Lack of history of using mental relaxation methods
0 Appropriate Mental Cognitive Ability According to Abbreviated Mental Test (AMT)
- Lack of chronic pain affecting sleep quality
- Do not have hearing problems diagnosed by a medicine.
- Non-smoking
- Access to audio file playback technology (CD player or smartphone)
- Consent to participate in research
Intervention groups
The intervention group will receive a guided imagery audio file.
Main outcome variables
guided imagery, sleep quality, general health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210925052570N1
Registration date:2022-02-20, 1400/12/01
Registration timing:registered_while_recruiting
Last update:2022-02-20, 1400/12/01
Update count:0
Registration date
2022-02-20, 1400/12/01
Registrant information
Name
mahdieh heidarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3378 0723
Email address
mahdieh.heidarian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-03, 1400/11/14
Expected recruitment end date
2022-04-03, 1401/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of guided imagery on quality of sleep and general health among older adults with sleep disorders
Public title
Effect of guided imagery on quality of sleep and general health among older adults with sleep disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women 60 years and older
A score of 5 or higher on the Pittsburgh Sleep Quality Questionnaire
No history of using mental relaxation methods
Appropriate mental-cognitive ability according to Abbreviated Mental Test (AMT)
Do not have hearing problems diagnosed by a MD
Do not take new sleeping medicine during the study
Lack of chronic pain affecting sleep quality
Exclusion criteria:
Hospitalization during the study period
Reluctance of the participant to continue participating in the research
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting 70 elderly people referring to health centers based on the inclusion criteria and the available method, randomization will be done randomly using the random number table method and intervention and control groups will be assigned to two groups of 35 people. For this purpose, from 01 to 70 codes will be assigned to each of the studied samples. Then a row and column of the table are randomly selected. The intersection point of the selected row and column is the starting point of sampling. From this point, a plus or a cross is drawn. All numbers placed on this plus or a cross are selected as sample members.
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 University of social welfare and rehabilitation
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
tehran
Province
Tehran
Postal code
1985713871
Approval date
2022-01-02, 1400/10/12
Ethics committee reference number
IR.USWR.REC.1400.239
Health conditions studied
1
Description of health condition studied
sleep problems
ICD-10 code
Z72.82
ICD-10 code description
Problems related to sleep
Primary outcomes
1
Description
Percentage of people with a Pittsburgh Sleep Quality Questionnaire score less than 5.
Timepoint
Measure sleep quality score before and after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Members of the intervention group will receive a guided imagery audio file. This file contains 10 minutes of guided imagery. The audio in the form of a CD or MP3 file will be provided to the members of the intervention group. Everyone in the intervention group will listen to the CD at home for 10 minutes, once a day at a set time, for four weeks. On a daily basis, by making a phone call, the process will be reviewed, people will be encouraged to perform it regularly, and the participants' questions will be answered.
Category
Lifestyle
2
Description
Control group: The control group will receive only routine care. This group will also complete the questionnaires in parallel with the intervention group before, after and one month after the intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Javid Mohseni Health Centre
Full name of responsible person
Mahdieh Heidarian
Street address
Hejazi Ave, Emam Khomeini street.
City
ardabil
Province
Ardabil
Postal code
5619686191
Phone
+98 45 3378 0723
Email
mahdieh.heidarian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Masoud Fallahi
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Mahdieh Heidarian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 45 3378 0723
Email
mahdieh.heidarian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Farahnaz Mohammadi Shahbolaghi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University of Rehabilitation and Social Welfare, Koodakyar Avenue, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0036
Email
f.mohammadi@uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mahdieh Heidarian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University of rehabilitation and social welfare, koodakyar avenue, even
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0036
Email
Mahdieh.heidarian@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