Determining the effect of emotion release technique on sleep quality and mental health of the elderly
Design
Samples will be selected from people over 60 years old. After evaluating the elderly, the samples will be selected based on inclusion and exclusion criteria. The subjects of the intervention group perform EFT technique for 6 days, twice a day and each time for 20 minutes. Follow-up of EFT will be done daily by phone. The control group will not receive any intervention.
Settings and conduct
First, the city is divided into three regions: north, south and center, and then from each region, three health centers are randomly selected as clusters, and then the elderly are randomly selected from the list of names of these centers
Participants/Inclusion and exclusion criteria
Inclusion criteria
1) Age 60-70 years
2) Having insomnia based on the sleep quality questionnaire score (score higher than 5 Pittsburgh scales)
Exclusion criteria
1) Lack of cooperation during the intervention
2) Use of benzodiazepines and other sedatives and hypnotics during the study
Intervention groups
Samples will be selected from people over 60 years old. After evaluating the elderly, the samples will be selected based on inclusion and exclusion criteria. The participants of the intervention group perform EFT technique for 6 days, twice a day and each time for 20 minutes. This technique is taught to the elderly in person so that the person can do it himself. Follow up daily EFT by phone Will be done. The control group will not receive any intervention. And after performing the research steps, this group will be trained in EFT. The samples of the control group will not receive any intervention.
Main outcome variables
Sleep quality and mental health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210626051707N1
Registration date:2021-12-01, 1400/09/10
Registration timing:registered_while_recruiting
Last update:2021-12-01, 1400/09/10
Update count:0
Registration date
2021-12-01, 1400/09/10
Registrant information
Name
Habib Zaheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3324 1473
Email address
habibzaheri4060@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-21, 1400/08/30
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of emotion release technique on sleep quality and mental health of the elderly
Public title
The effect of emotion release technique on sleep quality and mental health of the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60-70 years
Insomnia based on sleep quality questionnaire score (score above 5 Pittsburgh scales)
Dont have a serious physical and mental illness
Dont have a cognitive deficits (score less than 7 on the Cognitive Status Questionnaire (AMT) Abbreviated mental test
Dont have a drug addiction
Dont have a wounds in the areas of energy channels
Exclusion criteria:
Lack of cooperation during the intervention
Use of benzodiazepines and other sedatives and hypnotics during the study
getting severe physical and mental illness during the study
Occurrence of unfortunate events such as mourning and loss of elderly loved ones during research
Age
From 60 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
According to the inclusion and exclusion criteria, people enter the study. In order to equalize the distribution of two important confounders of age and sex, classes based on these two variables are described as "age group 60 to 65 years / age group 65 to 70 years / age group 70 to 75 years / age group 75 to 80 years" and The "male / female class" is created and then randomly divided into two groups of treatment and control in a balanced way (Block Randomization)The size of each block is 4 items, so that 6 different combinations of 4 blocks are created and are selected randomly by placing the blocks. Using this method, the sample size in the two study arms will be equal (balance) and the difference between the two groups in terms of sample size will be equal to a maximum of half a block (two people).
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
Lorestan Medical Sciences Ethics Committee
Street address
Lorestan, Khorramabad, Lorestan University of Medical Sciences, Campus Kamalvand, Vice Chancellor for Research and Technology
City
Khorram Abad
Province
Lorestan
Postal code
381351698
Approval date
2021-03-12, 1399/12/22
Ethics committee reference number
IR.LUMS.REC.1399.365
Health conditions studied
1
Description of health condition studied
Elderly
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sleep quality
Timepoint
Assessment of sleep quality scores before the intervention will be on the last day of the intervention and one month after the intervention
Method of measurement
Based on the Pittsburgh Standard Questionnaire
Secondary outcomes
1
Description
mental health
Timepoint
Before the intervention, it will be on the last day of the intervention and one month after the intervention
Method of measurement
Based on the DASS standard questionnaire
Intervention groups
1
Description
Intervention group: In this clinical trial, after obtaining the approval of the ethics committee and the necessary permits from the Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences, the intervention will begin and samples will be collected. Then, with informed consent, seniors with inclusion criteria will complete demographic information questionnaires, the Pittsburgh Sleep Quality Scale, and the Short Cognitive Status Scale.Sampling method in this study is a multi-stage method including cluster and random. They are randomly selected from the list of names of these centers.It should be noted that the list of elderly people with files in health centers after receiving administrative and legal steps, will be received from each center and samples will be selected from people over 60 years. After evaluating the elderly, samples based on inclusion criteria and Exits are selected. The intervention group performs EFT technique for 6 days, twice a day for 20 minutes each time.This technique is taught to the elderly in person so that the person can do it himself. This technique will be taught individually to the elderly. EFT follow-up will be done daily by telephone.
Category
Behavior
2
Description
Control group: The control group does not receive any intervention. After performing the research steps, this group is trained in EFT. The samples of the control group do not receive any intervention and after the intervention, the EFT technique, if desired, These people will be trained. The EFT technique will be performed according to the EFT guide
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Nasser Khosrow Comprehensive Health Service Center
Full name of responsible person
Saman Hatami
Street address
Khatam Al-Anbia Street, above the emergency intersection on the right in front of Haft Store
City
KHORRAM ABAD
Province
Lorestan
Postal code
6816847175
Phone
+98 66 3324 1473
Email
habibzaheri4060@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Ebrahim Falahi
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical Sciences Khoramabad, Lorestan, Iran
City
Khorram Abad
Province
Lorestan
Postal code
381251698
Phone
+98 66 3312 0173
Email
reserch@Lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?