Protocol summary

Summary
The purpose of this study was to examine the effects of acupressure on pain and vital signs of patients undergoing the venipuncture procedures. This was a double blind quasi-experimental controlled trial study in which 180 patients refereed to Shohadaye Ashayer hospital and didn't have any sight disorder, addiction, history of diabetes mellitus, acute or chronic pain randomly selected. Balanced randomization method was used to allocate participants in to acupressure group (n=60) receiving acupressure at the correct points , placebo group (n=60) receiving acupressure at sham points and control group with routine care. Venipuncture procedure in all groups were performed on both hands of the patients. The first time the procedure performed without any modality in one hand and the second time performed with intervention on the other hand. Pain (using VAS) and vital signs (pulse rate, diastole and systole blood pressure, O2 saturation) were measured before, during and immediately after the intervention . Subjects in acupressure group received acupressure in LI4، H7 and Extra1 points and duration of massage was 9 minute (3 minute per acupoint) . Placebo acupoint group experienced massage in pseudo points with about 1-1.5 cm distance near to the true points with the same technique and duration.Venipuncture procedure were performed on both hands of the subjects of the control group without any intervention .The mean scores of pain of each group were compared before and after the intervention. Also the mean scores of pain of three groups were compared before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203159302N1
Registration date: 2012-09-22, 1391/07/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-09-22, 1391/07/01
Registrant information
Name
Reza Hosseinabadi
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1620 0140
Email address
reza.hosseinabadi@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2012-06-09, 1391/03/20
Expected recruitment end date
2012-11-10, 1391/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acupoint Massage on Pain of Patients Undergoing Venipuncture procedures
Public title
ٍEffect of Acupressure on Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Age of 16-45; Both male and female; Patient with medical problems; To have minimum of two ordered blood Laboratorytests in a day Exclusion criteria : Neuralgic disease; Mellitus debate; Addiction; Consumption Anti pain drug during last day; pregnancy; To have open wounds in hands or face; inappropriate vain;
Age
From 16 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
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
Ethic committee of Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences, kamalvand, khorramabad, Iran
City
Khorramabad
Postal code
Iran
Approval date
2011-12-20, 1390/09/29
Ethics committee reference number
200/58951

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
R 52.0
ICD-10 code description
Acute Pain

Primary outcomes

1

Description
Pain
Timepoint
Before, during and immediately after the intervention
Method of measurement
Visual Analog Scale(VAS)

Secondary outcomes

1

Description
Pulse
Timepoint
Before, during and after the intervention
Method of measurement
Pulse oximetry devices

2

Description
Arterial oxygen saturation
Timepoint
Before, during and after the intervention
Method of measurement
Ppulse oximetry devices

Intervention groups

1

Description
The first venipuncture procedure were performed without intervention on the one hand, then anti pain acupoint fingertips massage was performed with a minimum weight of 3 kg and duration of 9 minute(3 minute per acupoint) before and during the venipuncture procedure on the other hand of subjects of the intervention group .
Category
Other

2

Description
Participants in placebo group were received venipuncture procedure without intervention on the one hand then, pseudo points finger tips massage with about 1-1.5 cm distance near to the true points with a minimum weight of 3 kg and duration of 9 minute(3 minute per acupoint) were performed before and during the venipuncture procedure on the other hand.
Category
Treatment - Drugs

3

Description
Routine venipuncture procedure without fingertips massage were performed on both hands of subjects of the control group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Ashayer Hospital, Khorramabad, Iran
Full name of responsible person
Reza Hosseinabadi
Street address
Lorestan University of Medical Sciences, School of Nursing & Midwifery
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr Mohammad Kayedi
Street address
Lorestan University of Medical Sciences, Kamalvand, Khorramabad , Iran
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University of Medical Sciences
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
Lorestan University of Medical Sciences, Khorramabad School of Nursing & Midwifery
Full name of responsible person
Reza Hosseinabadi
Position
MSc in nursing
Other areas of specialty/work
Street address
Kamalvand, Khorramabad, Iran
City
Khorramabad
Postal code
Phone
+98 66 1620 0140
Fax
Email
reza.hosseinabadi@lums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Reza Hosseinabadi
Position
MSc in nursing
Other areas of specialty/work
Street address
Kamalvan, Korramabad, Iran
City
Khorramabad
Postal code
Phone
+98 66 1620 0140
Fax
Email
reza.hosseinabadi@lums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
reza hosseinabadi
Position
MSc in nursing
Other areas of specialty/work
Street address
Kamalvand, Korramabad, Iran
City
Khorramabad
Postal code
Phone
+98 66 1620 0140
Fax
Email
reza.hosseinabadi@lums.ac.irreza_hosseinabadi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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