Evaluation of the Effect of the P6 Acupressure on the amount of anxiety and the intensity of the pain caused by the venipuncture in patients with Thalassemia who admitted in Cooley’s ward
Design
A randomized controlled clinical trial with parallel groups, without blinding, 80 patients
Settings and conduct
This study will be performed on thalassemic patients admitted to the collision ward of Shahid Beheshti Hospital of Yasuj University of Medical Sciences. After obtaining permission during the data gathering phase, the researcher divides patients into two groups of experimental and control. Anxiety was measured in both groups before the venipuncture using Spielberger questionnaire. In the experimental group, point P6 will be used for acupressure. During the intervention, the researcher assesses and records the patient's pain. Then, after intervention, the patient's anxiety level was reassessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Ability to communicate and answer questions
2- Consent to participate in the study and sign the informed consent form
Exclusion criteria:
1- Patient's dissatisfaction with the study
2. Failure of a vein to be successful or need to be repeated
3 - taking analgesics within 3 hours before or during the study
4. Receive another painful intervention while the angiocut is embedded
5- Use of hypnotic, anxiolytic and antidepressant drugs before intervention
Intervention groups
Intervention group consisting of P6 Acupressure on the amount of anxiety and the intensity of the pain caused by the venipuncture in patients with Thalassemia who admitted in Cooley’s ward
Control group included of P6 Acupressure on the amount of anxiety and the intensity of the pain caused by the venipuncture in patients with Thalassemia who admitted in Cooley’s ward
Main outcome variables
The amount of anxiety and the intensity of the pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200109046066N1
Registration date:2020-03-14, 1398/12/24
Registration timing:registered_while_recruiting
Last update:2020-03-14, 1398/12/24
Update count:0
Registration date
2020-03-14, 1398/12/24
Registrant information
Name
Saeideh Avini athar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 5651
Email address
saeideh.avini@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-08, 1398/11/19
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the P6 Acupressure on the amount of anxiety and the intensity of the pain caused by the venipuncture in patients with Thalassemia
Public title
Effect of the P6 Acupressure on the amount of anxiety and the intensity of the pain caused by the venipuncture in patients with Thalassemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to communicate and answer questions
Consent to participate in the study and sign the informed consent form
Exclusion criteria:
Patient's dissatisfaction with the study
Failure of venipuncture or need to be reunited
taking analgesics within 3 hours before or during the study
Receive another painful intervention while the angiocut is embedded
Use of hypnotic, anxiolytic and antidepressant drugs before intervention
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
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 Yasuj University of Medical Sciences
Severity of pain during and after the intervention
Method of measurement
Visual Analogue Scale(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Spielberger questionnaire will be completed before venipuncture. The intervention will be done using acupressure point P6. The P6 point is located on the inner side of the arm and in the cavity between the forearm bones about three fingers wide above the wrist. In order to intervene, pressurize to the point 3 to 5 kg bilaterally in both hands, for 3 minutes with the thumb, 3 minutes each, and 2 minutes rest, rotating and two rounds per second. To be. So that the patient feels a tingling and numbness in his hand. Then, using standard points, an angiocut (pink, size 20) is inserted for all patients, while the researcher assesses and records the patient's pain with a visual pain scale. Then, after the intervention, the patient's anxiety level will be re-measured.
Category
Treatment - Other
2
Description
Control group: According to the routine procedure, angiocut insertion is performed according to the required standard and, like the intervention group, the patient's pain is measured before and after the operation, anxiety and after the procedure.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Collision, Shahid Beheshti Hospital, Yasuj University of Medical Sciences
Full name of responsible person
Saeideh Avini athar
Street address
Shahid Beheshti Hospital, Shahid Mohammad Montazeri Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 4721
Fax
+98 74 3322 1811
Email
beheshtihospital@yasooj.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari Oryad
Street address
Yasuj- Shahid Motahari Boulevard- Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591616113
Phone
+98 74 3334 6078
Fax
+98 74 3333 7230
Email
oryad.hossein@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Saeideh Avini athar
Position
M.S student of internal surgery nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Farei 1 alley, Friday Market Ave, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591616113
Phone
+98 74 3333 5651
Email
saeideh.avini@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Saeideh Avini athar
Position
M.S student of internal surgery nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Farei 1 alley, Friday Market Ave, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591616113
Phone
+98 74 3333 5651
Email
saeideh.avini@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Saeideh Avini athar
Position
M.S student of internal surgery nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Farei 1 alley, Friday Market Ave, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591616113
Phone
+98 74 3333 5651
Email
saeideh.avini@yahoo.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
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