Protocol summary

Study aim
Comparison of the effect of acupressure in point of Yiang and P6 on anxiety, sleep quality ,nausea and vomiting in hemodialysis patients.
Design
This study includes three groups of point massage p6, yian and control group in parallel, double blind, the number of samples for each group is 12 people and the total sample is 36 people .we use Restricted randomization type of block randomization. In order to randomize the Random allocation software and pokets containing the intervention group are used and based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened and the assigned group of the participant is revealed.
Settings and conduct
The present study in the dialysis ward of Imam Ardabil Hospital is performed on dialysis patients. Patients and caregivers are unaware of how to perform massage on other groups.Because both methods are performed for all groups and the intervention method is done correctly and effectively and the other method is performed symbolically and incorrectly, patients and the caregiver are unaware of how to massage other groups.
Participants/Inclusion and exclusion criteria
Patient have a history of hemodialysis for at least six months, age group 18 to 65 years have inclusion criteria and patient with anxiety score less than 20, petersburg sleep standard less than 5 are exclusion criteria
Intervention groups
In the first group, acupressure is performed at point p6 of the inner part of the forearm as a massage with the index finger, and in the second group, acupressure at the Yiang point in the middle of the two eyebrows with massage of the thumb for 3-5 minutes, and in the third group at the false point. message is done three times a week for four weeks
Main outcome variables
Nausea and vomiting, anxiety, sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210403050823N2
Registration date: 2021-07-28, 1400/05/06
Registration timing: registered_while_recruiting

Last update: 2021-07-28, 1400/05/06
Update count: 0
Registration date
2021-07-28, 1400/05/06
Registrant information
Name
solmaz saeidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3242 6606
Email address
solmaz.saeidi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-26, 1400/05/04
Expected recruitment end date
2021-08-26, 1400/06/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure at P6 and Yiang point on anxiety, sleep quality, nausea and vomiting in hemodialysis patients
Public title
The effect of acupressure on anxiety, sleep quality, nausea and vomiting in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Perform permanent hemodialysis Have a history of hemodialysis for at least six months Age group 18 to 65 years Ability to communication
Exclusion criteria:
Withdrawal from study Hospitalization of the patient during the intervention Amputation at the site of acupressure Anxiety score less than 20 Petersburg sleep standard less than 5
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
We will use method of Restricted randomization type of block randomization. Randomized tool is Random allocation software.We use the Allocation concealment method to hide that by using of pocket with Sequentially numbered, sealed, opaque envelopes Each of the random sequences created is recorded on a card and the cards are placed in the letter envelopes in order.In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes of the letter is opened and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study participants and the people who do the intervention for the patients will be blind and think that the next groups will use this method as well.For all groups of patients in the same areas of acupressure, ineffective and symbolic massage is performed
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Khalkhal University of Medical Sciences
Street address
Mozaffar
City
Khalkhal
Province
Ardabil
Postal code
5681761351
Approval date
2021-07-11, 1400/04/20
Ethics committee reference number
IR.KHALUMS.REC.1400.005

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
R88.0
ICD-10 code description
Cloudy (hemodialysis) (peritoneal) dialysis effluent

Primary outcomes

1

Description
Sleep quality score above 5
Timepoint
Quality of sleep before the intervention and four weeks after the intervention
Method of measurement
Pietersburg Sleep Quality Questionnaire

Secondary outcomes

1

Description
Anxiety score
Timepoint
Before intervention and four weeks after intervention
Method of measurement
Spielberger anxiety inventory

Intervention groups

1

Description
Intervention group: Acupressure is performed in the first group on point P6, which is one of the points used to reduce patients' anxiety. This point is located between the inner forearm of the arm and in the cavity between the forearm bones about three inches wide and above the wrist crease.
Category
Prevention

2

Description
In the second intervention group, pressure is applied to the third eye area or yintang located between the eyebrows and the root of the nose.
Category
Prevention

3

Description
Control group: For the control group, the intervention is performed somewhere other than the main points and with the wrong massage, but at the same time
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ardebil University of Medical Sciences
Full name of responsible person
Esmaeel Mehraeen
Street address
Emam
City
Ardebil
Province
Ardabil
Postal code
5681761351
Phone
+98 45 3242 6606
Email
es.mehraeen@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khalkhal University of Medical Siences
Full name of responsible person
Eemaeil Mehraeen
Street address
Mozaffar
City
Khalkhal
Province
Ardabil
Postal code
5681761351
Phone
+98 45 3242 6606
Email
es.mehraeen@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khalkhal University of Medical Siences
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
Khalkhal Yuniversity of Medical Sciences
Full name of responsible person
Solmaz Saeidi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mozaffar
City
Khalkhal
Province
Ardabil
Postal code
5681731351
Phone
+98 45 3242 6606
Email
solmaz.saeidi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khalkhal University of Medical Sciences
Full name of responsible person
Solmaz Saeidi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mozaffar
City
Khalkhal
Province
Ardabil
Postal code
5681731351
Phone
+98 45 3242 6606
Email
solmaz.saeidi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Khalkhal University of Medical Sciences
Full name of responsible person
Solmaz Saeidi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mozaffar
City
Khalkhal
Province
Ardabil
Postal code
5681731351
Phone
+98 45 3242 6606
Email
solmaz.saeidi@gmail.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
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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