Determining the effect of emotional Freedom technique on sleep disorders in elderly of day care centers in Babol
Design
This study is based on two experimental and control groups. The study population consisted of two groups of 25 each the elderly live in the Day Care Center. Questionnaires were completed before the intervention, after finishing it, and will be performed by the researcher 1 month after the intervention.
Settings and conduct
This study is based on two experimental and control groups. The study population consisted of two groups of 25 each the elderly live in the Day Care Center. This is conducted for 6 weeks, 2 sessions per week and each session for 30-45 minutes. At the beginning of the interventions, for both test and control groups, first a training session with pamphlets it will be done.
Participants/Inclusion and exclusion criteria
Samples from elderly people over 60 years old who visit day care centers and have problem in sleep quality score will be selected. Elderly people with cognitive impairment, severe hearing loss, severe anxiety, severe depression and severe pain and, substance user, or if they are unwilling to cooperate and miss more than 1 meeting, will be excluded.
Intervention groups
The intervention group includes 25 elderly people who receive a 6-week intervention emotional freedom technique.
The control group includes 25 elderly people who receive sleep health education in one session.
Main outcome variables
Quality sleep, sleepiness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170725035278N2
Registration date:2020-12-13, 1399/09/23
Registration timing:retrospective
Last update:2020-12-13, 1399/09/23
Update count:0
Registration date
2020-12-13, 1399/09/23
Registrant information
Name
Samaneh Pourhadi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0560
Email address
s.pourhadi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-11, 1398/08/20
Expected recruitment end date
2020-05-04, 1399/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of emotional freedom technique(EFT) on sleep disorders of elderly in adult Day-Care Centers
Public title
The effectiveness of emotional freedom technique(EFT) on sleep disorders of elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly people over 60 years
Sleep quality score greater than 5 or sleepiness score greater than 10
Exclusion criteria:
Elderly with cognitive impairment
Severe hearing disorders
Severe Anxiety
Severe Depression
Smoking and alcohol
Lack of cooperation and absence from more than one meeting
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Babol University of Medical Sciences
Street address
No. 2, Modarres 21, Modarres St., Babol, Mazandaran Province
City
Babol
Province
Mazandaran
Postal code
4714933757
Approval date
2019-11-24, 1398/09/03
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.246
Health conditions studied
1
Description of health condition studied
sleep disorders
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
Primary outcomes
1
Description
Sleep quality
Timepoint
Before intervention, immediately and one month after intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
2
Description
Sleepiness
Timepoint
Before intervention, immediately and one month after intervention
Method of measurement
Epworth Sleepiness Questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before intervention, immediately and one month after intervention
Method of measurement
Quality of Life Questionnaire Control, Autonomy, Self-realization, Pleasure-19
2
Description
Anxiety
Timepoint
Before intervention, immediately and one month after intervention
Method of measurement
Geriatric Anxiety Inventory
3
Description
Depression
Timepoint
Before intervention, immediately and one month after intervention
Method of measurement
Geriatric Depression Scale
Intervention groups
1
Description
Intervention group: The Emotional Freedom Technique for 6 weeks, 2 sessions per week and 30-45 minutes per session.
Category
Behavior
2
Description
Control group: will receive sleep hygiene training in one session.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Daily Hamrah Salamat Center
Full name of responsible person
Samad Izadi
Street address
No. 101, Baharan 26, Western Belt, Babol
City
Babol
Province
Mazandaran
Postal code
4718658136
Phone
+98 11 3222 8457
Email
hamrahsalamat@yahoo.com
2
Recruitment center
Name of recruitment center
Avaye Mehr Daily Center
Full name of responsible person
MehrasaMirza Babazade
Street address
Feyzie 7, Next to the Karimnezhad Hall, Mirza Koch Khan Boulevard, Shahid Bazaz Square, Babol
City
Babol
Province
Mazandaran
Postal code
,,,,,,
Phone
+98 11 3237 3862
Email
Avayemehr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Vice chancellor for research, Babol University of Medical Sciences ,Ganj Afroz Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 0560
Email
s_ghoreishi68@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Seyedeh Sahar Ghoreishi
Position
Master of Science Student of Geriatric Health
Latest degree
Bachelor
Other areas of specialty/work
Audiology
Street address
Babol University of Medical Sciences ,Ganj Afroze street
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0560
Email
s_ghoreishi68@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Samaneh Pourhadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Babol University of Medical Sciences, Ganj Afroz Street
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0560
Email
samaneh.pourhadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Seyedeh Sahar Ghoreishi
Position
Master of Science Student of Geriatric Health
Latest degree
Bachelor
Other areas of specialty/work
Audiology
Street address
Babol University of Medical Sciences, Ganj Afroz Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 0560
Email
s_ghoreishi68@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available