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IRCT20230222057494N1 IRCT 2023-04-05 Shahroud University of Medical Sciences Acupressure combination of Sanyinjiao (SP6) and Shenmen (HT7) points and sleep quality of the elderly 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 2023-04-13 anticipated 126 Complete https://irct.ir/trial/68849 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Sleep quality. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Reza Mirafzali
Gorganjadid street
Gorgan Iran (Islamic Republic of) 4913796855 +98 17 3268 0347 rezamirafzali@shmu.ac.ir Shahroud University of Medical Sciences scientific Dr.Hossein bagheri
Hafte-Tir Square, Shahroud University of Medical Sciences
Shahroud Iran (Islamic Republic of) 3617753917 +98 23 3239 5054 bagheri@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) 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 60 years no limit Both 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 G47.9 Sleep disorder, unspecified Treatment - Other Treatment - Other Treatment - Other 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. 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. 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. Sleep Quality Based on Pittsburgh Sleep Quality Test Score. Timepoint: Before and one week after the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Shahroud University of Medical Sciences Approved 2023-02-05 Ethics committee of Shahroud University of Medical Sciences Shahroud University of Medical Sciences, Hafte-Tir Sq.,Tehran Street Shahroud Semnan Iran (Islamic Republic of)