Protocol summary

Study aim
The effect of emotion freedom technique on sleep quality and anxiety in the elderly
Design
This study is a type of clinical trial in Shiraz. participants of this study fall into two groups: intervention and control (40 people per group).
Settings and conduct
This study is a single blind clinical trial with a control group. Samples were selected based on the inclusion criteria, , Using the randomized block allocation method with a block size of 4 equal to two AABB groups are randomly divided, each group is 40 people and a total of 80 people are considered. The person assessing the consequences is unaware of the allocation of individuals in the groups. The study site will be in Pishgam physiotherapy clinic in shiraz, satarkhan Blvd.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age over 60 years, Patients with sleep disorders and anxiety according to the sleep quality and anxiety questionnaire, Absence of cognitive and motor disorders. Exclusion Criteria: History of using psychotropic or psychiatry drugs, As well as suffering from pain pain before the intervention.
Intervention groups
Intervention group: Intervention will performed in 8 sessions (twice a week for four weeks) for 15 minutes. In each session, participants are asked to rate their level of mental distress. Sequence of striking points, first the point of the karate stick and then the meridian point (head difference), between the eyebrows, both sides of the eyes, under the eyes, under the nose, under the lips, two claws in the chest, under the arms (below the armpit) The index finger, thumb, middle finger, and little finger are taught. These steps will be repeated during 8 sessions. Control Group: No intervention will be performed in the control group.
Main outcome variables
Anxiety and Sleep Quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180923041101N3
Registration date: 2021-04-16, 1400/01/27
Registration timing: prospective

Last update: 2021-04-16, 1400/01/27
Update count: 0
Registration date
2021-04-16, 1400/01/27
Registrant information
Name
Majid Najafi Kalyani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4251
Email address
najafikalyani@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-19, 1400/01/30
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Emotional Freedom Technique (EFT) on Sleep Quality and Anxiety of Elderly
Public title
The Effect of Emotional Freedom Technique (EFT) on Sleep Quality and Anxiety of Elderly
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 years and older Absence of mental illness or use of psychiatric and psychiatric drugs Patients with sleep and anxiety disorders according to the Sleep and Anxiety Quality Assessment Questionnaire Absence of cognitive and motor disorders
Exclusion criteria:
Pain before the intervention due to illnesses that prevents the intervention Lack of literacy to complete the questionnaires and understand the process of work
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
After selection of participants based on the inclusion criteria, the random allocation method in this study will be the permutation block method, where A represents the person receiving the intervention and B represents the person who does not receive the intervention. This method is performed by considering 4 blocks so that the total number of 4 permutations is equal to 6. Then, using a table of random numbers and assigning code zero to 9 to each of the permutations (ABAB code 0, BABA code 1, AABB code 2, BBAA code 3, BAAB code 4 and ABBA code 5 to 9), a random list of 60 The desired consisting of 20 blocks of 4 (4 * 20 = 80 total number of samples) is generated and the order of assignment to each of the samples participating in the study is determined. How to use the table of random numbers is that the starting point is selected randomly and 20 numbers from zero to 9 are selected randomly (row or column) and the permutation assigned to each number is noted. (The order of placement of shifts next to each other will be from left to right) and how to allocate a total of 80 people to two groups A and B will be determined. (40 people in each group). These steps are performed using random allocation software.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the evaluator of outcome are kept blind to the type of intervention. In this way, the outcome evaluator fills the questionnaire in the appointed time (day 1 and final day after 8 week), and does not know the allocation of the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee Shiraz University of Medical Sciences
Street address
Zand St
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2020-05-05, 1399/02/16
Ethics committee reference number
IR.SUMS.REC.1399.352

Health conditions studied

1

Description of health condition studied
Sleep quality, Anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sleep Quality
Timepoint
Day 1 and 35
Method of measurement
Pittsburg Inventory

2

Description
Anxiety
Timepoint
Day 1 and 35
Method of measurement
Speilberger's Anxiety Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention sessions are performed in 8 sessions (twice a week for four weeks) in the morning for 15 minutes while the elderly person is sitting on a chair. The technique is that at the beginning of each session, participants are asked to rate their level of mental distress on a scale of 1 to 10, with 1 indicating the lowest and 10 the highest level of distress. The statement confirming the acceptance of this mental disorder is repeated 3 times. For example, "Even if I have this problem, I accept myself deeply and completely", this phrase is different for each person. Sequence of striking points, first the point of the karate stick and then the meridian point (head difference), between the eyebrows, both sides of the eyes, under the eyes, under the nose, under the lips, two claws in the chest, under the arms (below the armpit) The index finger, thumb, middle finger, and little finger are taught, and participants are asked to repeat the affirmative phrase when tapping the point of the meridian and the karate stick. And then point 9 - Gammot and turning the eyes to communicate with the two hemispheres of the brain along with whispering favorite music is taught. These steps will be repeated during 8 sessions.
Category
Behavior

2

Description
Control group: A group on which no intervention will be made.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Pishgam Physiotherapy Clinic
Full name of responsible person
Habibollah Lari
Street address
Sattar Khan St
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3626 1192
Email
h_lari@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Poost Foroosh
Street address
Zand St, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Zahra Shakibavand
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zand St
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Email
nadia1374.ns@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Majid Najafi Kalyani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazee St
City
Shiraz
Province
Fars
Postal code
3119–171936
Phone
+98 71 3647 4251
Fax
Email
najafikalyani@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Majid Najafi Kalyani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazee St
City
Shiraz
Province
Fars
Postal code
3119–171936
Phone
+98 71 3647 4251
Fax
Email
najafikalyani@sums.ac.ir

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
Analyzed data can be shared after completion of the study as an article.
When the data will become available and for how long
Start of access period 6 months after publication of results.
To whom data/document is available
All of the researchers in Medical Sciences Universities.
Under which criteria data/document could be used
Analysis of data based on statistical software.
From where data/document is obtainable
Dr. Majid Najafi Kalyani
What processes are involved for a request to access data/document
Sending request, permission from Ethic Committee, sending data.
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