This interventional study is double blind clinical trial that examines the acupressure effect on pain and anxiety in patients undergoing bone marrow biopsy. The participants will be randomized into three groups of 30 patients (intervention, control and placebo). Half-hour before biopsy, all patients complete Spielberger anxiety questionnaire and the vital signs will be recorded by co-researcher. In the intervention group, the acupressure will be performed using researcher’s thumb on the He7 (anti-anxiety point) and the LI4 (anti-pain point). In the placebo group, the acupressure method is the same but in the different points without any anti-anxiety and anti-pain effect. No procedure will be performed in the control group. The anxiety and vital signs will be recorded again during and immediately after the biopsy. The pain will be measured using a visual analogue scale (VAS) after the biopsy was taken.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201038100N2
Registration date:2012-05-11, 1391/02/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-05-11, 1391/02/22
Registrant information
Name
Masoomeh Imanipour
Name of organization / entity
Tehran Universityof Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4425
Email address
m_imanipour@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nursing and Midwifery Care Research Center
Expected recruitment start date
2012-08-21, 1391/05/31
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acupressure on pain and anxiety in patients undergoing bone marrow biopsy
Public title
The effect of acupressure on pain and anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who are 18-65 years old, undergo bone marrow biopsy for the first time; have no previous experience of acupressure or acupuncture; have sufficient visual acuity to mark the visual analogue scale; are able to read; are not a professional person with knowledge of biopsy procedure; have no barrier such as IV catheters preventing access to the points of acupressure.
Exclusion criteria: occurrence of any problem or unexpected event during the biopsy procedure; patient’s refusal to continue with the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor for research, Tehran University of Medical Sciences
Street address
6th floor, Central building of the university, corner of Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2012-03-05, 1390/12/15
Ethics committee reference number
45519
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
C79.5
ICD-10 code description
Secondary malignant neoplasm of bone and bone marrow
Primary outcomes
1
Description
pain
Timepoint
During and immediately after the biopsy
Method of measurement
visual analouge scale
2
Description
anxiety
Timepoint
Before, during and immediately after the biopsy
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group, acupressure will be apply using the researcher thumb on the transverse fold of wrist which is directly in contact with flexor tendon, Carmen Ulnarys, known as “the seventh heart” or He7. This site is known as an anti-anxiety point in the traditional medicine. The same steps will be done in “Hugo” point or LI4 which is located in the hand, between the first and second metacarpal bones and in the traditional medicine known as an anti-pain point.
Category
Treatment - Other
2
Description
In the placebo group, the same method will be performed but in different points that do not have any effect on anxiety or pain in the traditional medicine.
Category
Placebo
3
Description
No procedure will be performed in the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nursing and Midwifery Care Research Center
Full name of responsible person
Dr. Reza Negarandeh
Street address
Nursina and Midwifery, Tehran University of Medical Sciences, Tohid sq
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nursing and Midwifery Care Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
M.S in nursing
Other areas of specialty/work
Street address
Nursing and Midwifery, Tehran University of Medical Sciences ,Tohid sq.
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
alizadeh_z10@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Medwifery, Tehran University of Medical Sciences
Full name of responsible person
Masoomeh Imanipour
Position
M.S in nursing, PhD candidate in medical education
Other areas of specialty/work
Street address
Nursing and Medwifery, Tehran University of Medical Sciences, Tohid sq.
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
m_imanipour@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Zahra Alizadeh
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)