This study is a clinical trial that examines the acupressure effect on pain and anxiety in cancer patients undergoing bone marrow biopsy. The participants will be randomized into three groups of 30 patients (intervention, control and placebo). Inclusion criteria were: age 18 to 65 years, undergo bone marrow biopsy for the first time, the lack of previous experience in acupressure or acupuncture and exclusion criteria included having a platelet count less than 100,000 milligrams per deciliter. In the experimental group, the acupressure will be performed on the LI4 (anti-pain point) and the He7 (anti-anxiety point) for 1 minutes in during and after the biopsy. In the placebo group, the acupressure will be performed on the same points at a distance of 1.5 cm from the main points. No procedure will be performed in the control group. Before biopsy, all patients complete Spielberger anxiety questionnaire and the vital signs will be recorded. The pain will be measured using a visual analogue scale (VAS) in 3 groups, before, during and after the biopsy. Also will be re-measured amount of anxiety and vital signs after the biopsy
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016080229159N1
Registration date:2017-04-27, 1396/02/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-27, 1396/02/07
Registrant information
Name
Moloud Sharifi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 5525 8118
Email address
m.sharifi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2016-12-10, 1395/09/20
Expected recruitment end date
2017-03-07, 1395/12/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trials The effectiveness of acupressure on pain and anxiety in cancer patients undergoing bone marrow aspiration and biopsy
Public title
The effect of acupressure on severity of pain and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Having a pathology confirms the person with cancer; Having full consciousness; Age 18 to 65 years years; Avoiding the use of anxiolytic and analgesic medications 12 hours before the procedure; No barrier in place Acupressure such as IV line, ulcer at the site of compression; Bone marrow biopsy is done for the first time;The lack of visual impairment to see a visual scale for pain intensity; Having reading and writing literacy needed for completing the questionnaire; having no experience or knowledge about acupressure.
Exclusion criteria: the platelets level decreases to less than 100000 mg/dL, any problem or accident happens during the biopsy and unwillingness for cooperation to be continued.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study uses a sampling method, 90 patients were randomized into 3 groups of 30 blocks, a group of acupressure, placebo and one group studied the routine care
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Gangafrooz Street, Babol, Mazandaran
City
Babol
Postal code
4717647745
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
MUBABOL.HRI.REC.1395.39
Health conditions studied
1
Description of health condition studied
neoplasm
ICD-10 code
C00, C01,
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
pain
Timepoint
Before biopsy, during biopsy, immediately after the biopsy
Method of measurement
vas(Visual Analogue Scale)
2
Description
Anxiety
Timepoint
Before and after biopsy
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group, acupressure will be applyin “Hugo” point or LI4 which is located in the hand, between the first and second metacarpal bones and the seventh heart or He7 which is located in the transverse fold of wrist which is directly in contact with flexor tendon, Carmen Ulnarys for 1 minute to will be done symmetrically on both hands.
Category
Other
2
Description
In the placebo group, the acupressure will be performed on the same points at a distance of 1.5 cm from the main points,for 1 minute to will be done symmetrically on both hands that these points will be ineffective and will have no effect on anxiety and pain .
Category
Other
3
Description
Control group, No procedure will be performed in the control group.