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Investigating the effectiveness of the acupressure combination of Sanyinjiao (SP6) and Shenmen (HT7) points on the sleep quality of the elderly: A family-oriented three parallel group clinical trial

Protocol summary

Study aim
Determining the effectiveness of the acupressure combination of Sanyinjiao and Shenmen points on the sleep quality of the elderly
Design
Clinical trial of three groups without control group, with parallel groups, randomized, without blinding
Settings and conduct
The location of the study will be the clinics of Shahroud city. In a face-to-face meeting, the researcher teaches the elderly caregiver how to press the mentioned points, and they must perform this action on the elderly once a day at night time at 10-11 pm. Before and one week after the intervention, Pittsburgh questionnaire will be completed for all three groups.
Participants/Inclusion and exclusion criteria
Entering criteria for elderly: age > 60 years, informed consent, MMSE>22 in literate people and AMTS>7 in illiterate people, unfavorable sleep quality based on Pittsburgh questionnaire. Exclusion criteria for elderly: receiving other sleep-related treatments within 2 weeks before the study, history of mental illness, dependence or addiction to any narcotic, painkiller, antidepressant. Inclusion criteria for the elderly caregiver: having the most contact with the elderly, the health literacy score more than 66.1 from the HELIA questionnaire. Exclusion criteria for the elderly caregiver: Having any physical disease related to the fingers
Intervention groups
In group A (Shenmen), B (Sanyinjiao) and C (combination of Shenmen and Sanyinjiao), in a face-to-face meeting, the researcher will teach the person accompanying the elderly to press the mentioned points, and they should do it once a day for a week at 10-11 pm, for elderly. This study has no control group.
Main outcome variables
Sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230222057494N1
Registration date: 2023-04-05, 1402/01/16
Registration timing: prospective

Last update: 2023-04-05, 1402/01/16
Update count: 0
Registration date
2023-04-05, 1402/01/16
Registrant information
Name
Reza Mirafzali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3268 0347
Email address
rezamirafzali@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-13, 1402/01/24
Expected recruitment end date
2023-11-11, 1402/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of the acupressure combination of Sanyinjiao (SP6) and Shenmen (HT7) points on the sleep quality of the elderly: A family-oriented three parallel group clinical trial
Public title
Acupressure combination of Sanyinjiao (SP6) and Shenmen (HT7) points and sleep quality of the elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age over 60 years old Having full awareness and listening and speaking ability suitable for learning research intervention MMSE score more than 22 in literate people and AMTS score more than 7 in illiterate people Unfavorable sleep quality based on answers to the Pittsburgh sleep quality questionnaire (a score of 5-21 is considered as unfavorable sleep quality) Entry criteria for the person accompanying the elderly: 1- To have the most contact with the elderly. To have the ability to correctly implement the intervention on the elderly The health literacy score is more than 66.1 from the HELIA questionnaire
Exclusion criteria:
Secondary insomnia caused by physical illness or mental disorder Those who received other sleep-related treatments within 2 weeks before the study. History of mental illness (based on the elderly's self-report) Dependence or addiction to any drug, pain reliever, anti-depressant, sleeping pill and alcohol Having sleep-related diseases such as obstructive sleep apnea or restless legs syndrome Regarding the person accompanying the elderly: Having any physical disease related to the fingers
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into three groups through randomization and based on the production of random numbers strings through software. (www.randomizer.org) In order for the number of assignments to each group to be equal, the block method of volume 6 is used to create a random allocation sequence because participants are gradually entered into the study. The allocation concealment will be done centrally. In this way, the assignment sequence will be done by someone outside the research team. Upon each person entering the study, the researcher will contact the person and assign the person to the group.
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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Hafte-Tir Sq.,Tehran Street
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2023-02-05, 1401/11/16
Ethics committee reference number
IR.SHMU.REC.1401.219

Health conditions studied

1

Description of health condition studied
Sleep quality
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified

Primary outcomes

1

Description
Sleep Quality Based on Pittsburgh Sleep Quality Test Score
Timepoint
Before and one week after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In this group (group A), first in a face-to-face session, pressing the Shenmen point (HT7) (on the ulnar side, the distal volar bands of the wrist and the radial border of the flexor carpi ulnaris tendon in the anterior region of the wrist) with A pressure of 3 to 4 kg using a circular motion with a speed of two revolutions per second in a firm and uniform way for one minute pressure 30 seconds rest up to 3 times with the thumb by the researcher is taught to the person with the intervention group and they must do it once every day at night at 10-11 for a week. Perform this procedure on the elderly themselves and repeat it.
Category
Treatment - Other

2

Description
Intervention group 2: In this group (group B), first, in a face-to-face session, pressing the Sanyinjiao point (SP6) (directly to the tip of the medial malleolus, the posterior margin of the medial leg of the leg) with a pressure of 3 to 4 kg using A circular movement with a speed of two revolutions per second in a firm and uniform way for one minute, pressure for 30 seconds, rest up to 3 times with the thumb is taught by the researcher to the person accompanying the people of the intervention group, and they should do this procedure on the elderly themselves for a week, once every day at night time at 10-11 and repeat.
Category
Treatment - Other

3

Description
Intervention group 3: In this group (group C), first in a face-to-face meeting, pressing the Shenmen point (HT7) (on the ulnar side, the distal volar bands of the wrist and the radial border of the flexor carpi ulnaris tendon in the anterior region of the wrist) and the Sanyinjiao point (SP6) (straight up to the tip of the medial malleolus, the posterior border of the inner leg of the leg) with a pressure of 3 to 4 kg using a circular motion at a speed of two rotations per second in a firm and uniform manner for one minute of pressure and 30 seconds of rest. Up to 3 times, the person accompanying the intervention group will be trained by the researcher with the thumb up to 3 times, and they They should perform and repeat this procedure on the elderly once every day at night at 10-11 for a week and repeat.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinics in Shahroud city
Full name of responsible person
Dr. Hossein Bagheri
Street address
Hafte-Tir Sq.,Tehran Street
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir
Web page address
http://eh.shmu.ac.ir/home.html

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad-Hassan Emamian
Street address
Haft-Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
6314773955
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Web page address
http://research.shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Reza Mirafzali
Position
Master's student in geriatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gorganjadid street
City
Gorgan
Province
Golestan
Postal code
4913796855
Phone
+98 17 3268 0347
Email
rezamirafzali@shmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Hossein bagheri
Position
َAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hafte-Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3617753917
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Reza Mirafzali
Position
Master's student in geriatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gorganjadid street
City
Gorgan
Province
Golestan
Postal code
4913796855
Phone
+98 17 3268 0347
Email
rezamirafzali@shmu.ac.ir

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
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