The effect of acupressure on anxiety, fatigue and blood pressure in patients undergoing hemodialysis
Design
In this study, it is a randomized controlled clinical trial with a before-and-after design, among the patients undergoing hemodialysis who meet the inclusion criteria, 105 people will be selected by random permutation blocks and will be divided into three acupressure groups. 35 people), sham (35 people) and control (35 people) points will be placed.
Settings and conduct
The location of the study is the 9-day Torbet Heydarieh hospital and the dialysis clinic of the city. The Spielberger anxiety and fatigue questionnaire is filled before and after the intervention, then it is filled again one month after the intervention. The blood pressure of the patients is also recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
- At least 18 years old
- Dialysis treatment for at least 6 months
- Perform dialysis at least 2 times a week and each time for 3-4 hours
- Absence of contraindications to acupressure
- Listening and speaking ability
- Not taking sedatives such as benzodiazepines
- Willingness to cooperate in the study
Exit criteria
- Performing kidney transplant or peritoneal dialysis during research
- Suffering from hemodynamic complications in most dialysis sessions
- Unwillingness to continue cooperation in the study
Intervention groups
Acupressure group massage is performed at the specified points at the beginning of dialysis that does not interfere with the patient's dialysis. Sham points group will receive acupressure on false points where applying pressure has no soothing effect. The control group will not have any intervention on the patients.
Main outcome variables
Reducing patients' anxiety, reducing fatigue and controlling blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221223056899N1
Registration date:2022-12-28, 1401/10/07
Registration timing:prospective
Last update:2022-12-28, 1401/10/07
Update count:0
Registration date
2022-12-28, 1401/10/07
Registrant information
Name
toktam soleimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5223 9677
Email address
soleimanitoktam1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on anxiety, fatigue and blood pressure in patients undergoing hemodialysis
Public title
The effect of acupressure on anxiety, fatigue and blood pressure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Dialysis at least 2 times a week and each time for 3-4 hours
Dialysis treatment for at least 6 months
willingness to cooperate in the study
no use of sedatives such as benzodiazepines
Hearing ability and speech
No limb amputation or wound at the place of massage
No contraindications to acupressure
Age at least 18 years
Exclusion criteria:
Hospitalization of the patient during intervention
Suffering from hemodynamic complications in most dialysis sessions
The occurrence of a severe stressful event, such as the death of a first-degree relative
Travel or death of the patient
Unwillingness to continue cooperation in the study
Performing kidney transplant or peritoneal dialysis during research
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
All sample people are divided into three equal groups by simple random method. First, 105 cards (the same as the sample size) will be prepared. Then, one of the letters A, B or C will be written on each card. These cards will be placed inside a box so that nobody can see the cards inside the box. After the researcher shuffles the cards, the patients are asked to randomly pick a card from the box (the selected cards are not returned to the box after selection). In this way, people are placed in three groups of 35 people A, B and C. In this way, three cards are prepared and one of the numbers 1, 2 and 3 will be written on each card. Number 1, 2 and 3 will belong to intervention, sham and control respectively. These cards are placed in a box and after mixing, the researcher will randomly select one card for each group (the selected cards will not return to the box after selection).
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients are divided into three intervention groups, sham points and control. The patients of the intervention group receive acupressure in real points and sham acupressure spheres in false points. The patients do not know the exact location of the points. In this study, the researcher's help in completing All questionnaires will be used for blinding and to prevent bias in the results. In this way, the researcher's help will be unaware of the groupings and the type of interventions that are carried out in each group and by each person.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
No.24,Ghaem29/1 Ave
City
Torbat-Heydariyeh
Province
Razavi Khorasan
Postal code
9518656667
Approval date
2022-03-09, 1400/12/18
Ethics committee reference number
IR.BUMS.REC.1400.443
Health conditions studied
1
Description of health condition studied
Renal failure
ICD-10 code
N17-N19
ICD-10 code description
Primary outcomes
1
Description
Reducing the level of anxiety
Timepoint
Before the start of the intervention, after the end of the intervention and one month after the end of the intervention
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
1
Description
Reducing the fatigue level of hemodialysis patients
Timepoint
Before and after the intervention
Method of measurement
Paper fatigue questionnaire
Intervention groups
1
Description
The patients of acupressure group are massaged at PC6 or Nei Guan points, GV 20 and ST36 (both legs) in total (9 points) by the thumb pulp of the therapist's hand and at the beginning of dialysis, which does not interfere with the patient's dialysis. The pressure level is 3 to 4 kg for 10 minutes. It will be done three times a week for 4 weeks. Follow-up is also done in the dialysis sessions, which the patient is definitely present.
Category
Treatment - Other
2
Description
Control group: Sham points group patients will receive acupressure on false points where applying pressure does not have any soothing effect, in the form of massage on two SP9 points that are inside the leg at the junction of the tibial shaft and the tibial condyle in a depression (to instead of ST36) and point CV24, which is exactly between the chin and lower lip on the front midline of the body in the middle of the distance between lip and chin (instead of GV20) and point SP6 (instead of LV3) and point KI27 (instead of GB 20) and point TW 6 (instead of PC6) will be performed by the therapist's thumb pulp with a pressure of 3 to 4 kg for 10 minutes three times a week for 4 weeks.
Category
Treatment - Other
3
Description
Control group: In the control group, no intervention will be performed on the patients.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
9th Day Hospital and Dialysis Clinic
Full name of responsible person
Toktam Soleimani
Street address
No.24,Ghaem29/1Ave
City
Torbat-Heydariyeh
Province
Razavi Khorasan
Postal code
9518656667
Phone
+98 915 090 5641
Email
soleimanitoktam1374@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ahmad Nasiri
Street address
Ghafari Ave.Birjand University of Medical Sciences, Faculty of Nursing and Midwifery
City
Birjand
Province
Razavi Khorasan
Postal code
9717853577
Phone
+98 915 163 7519
Email
nasiri2006@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Toktam Soleimani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.24,Ghaem29/1Ave
City
Torbat-Heydariyeh
Province
Razavi Khorasan
Postal code
9518656667
Phone
+98 51 5223 9677
Email
soleimanitoktam1374@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Toktam Soleimani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.24,Ghaem29/1Ave
City
Torbat-Heydariyeh
Province
Razavi Khorasan
Postal code
9518656667
Phone
+98 51 5223 9677
Email
soleimanitoktam1374@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Toktam Soleimani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.24,Ghaem29/1Ave
City
Torbat-Heydariyeh
Province
Razavi Khorasan
Postal code
9518656667
Phone
+98 51 5223 9677
Email
soleimanitoktam1374@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
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
1400
To whom data/document is available
Toktam Soleimani
Under which criteria data/document could be used
For further studies
From where data/document is obtainable
Toktam Soleimani
What processes are involved for a request to access data/document