This study is performed to investigate the effect of acupressure at neiguan point on anxiety and pain in patients undergoing inguinal hernia surgery. This clinical trial,included two groups and was single blinded. In This study, 88 patients who underwent inguinal hernia and their age ranged from 13 to 75 years, were examined. The patients were under general anesthesia with endotracheal tube and without any mental illness and addiction. The subjects were randomly assigned to two groups of intervention (n = 44) and placebo (n = 44). In the intervention group, acupressure was applied using wristbands buttons tension in the neiguan point, and in the placebo group wristbands without buttons tension was placed loosely in false point. measurements were made in two steps (before and after surgery). Wristbands were placed once for 5 minutes before surgery, and anxiety were measured before and after intervention using the Spielberger questionnaire. After surgery, when the patient become alert, acupressure wristbands were placed every two hours for 5 minutes to 6 hours, and pain level was measured based on the assessment protocol of vital sign.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062322888N1
Registration date:2015-08-23, 1394/06/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-23, 1394/06/01
Registrant information
Name
Fatemeh Zeynali
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4444 6070
Email address
fatemeh.z134@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Sabzevar University of Medical Sciences
Expected recruitment start date
2015-02-04, 1393/11/15
Expected recruitment end date
2015-05-05, 1394/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison acupressure effect between neiguan point and placebo on pain and anxiety in inguinal hernia surgery
Public title
effect of acupressure on pain, and anxiety in inguinal hernia surgery
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
age range 13-75 years, general anesthesia with endotracheal intubation,
The Neiguan region do not have any deformity and injuries,
Didn't have any history of mental disorder ,addiction and history of previous abdominal surgery
,Ability to speak and understand the Persian language.
Exclusion criteria included:
Discontent for the use of wristbands at any time of the study,
Do not use opioid drugs and sedative for 4 hours before the intervention,
Long operation time and the incidence of adverse events recorded in the patient during surgery.
Age
From 13 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
A pilot study was done on 54 patients the same quality of the original study and the sample size was determined 88. Permutation block method was used to divide patients to intervention and placebo groups. Patients in this study were blind and unaware of the type of groups that were in it. This study was conducted with self-made wristbands.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences.
Street address
Building number one, next to the police station to SHahroud road, The School of Nursing and Midwifery, University of Medical Sciences and Health Services, sabzevar
City
Sabzevar
Postal code
Approval date
2015-02-04, 1393/11/15
Ethics committee reference number
medsab.Rec.93.65
Health conditions studied
1
Description of health condition studied
Inguinal Hernia
ICD-10 code
K40.9
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene
Primary outcomes
1
Description
pain
Timepoint
before the surgery and after the surgery to 6 hours
Method of measurement
Visual Analogue Scale
2
Description
Anxiety
Timepoint
before the surgery
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group received acupressure on neiguan point with an wristbands with a button applies pressure for 5 minutes.
Category
Treatment - Other
2
Description
placebo group received light pressure with an wristbands without a button applies pressure in false points for 5 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
sabzevar Emdad Hospital
Full name of responsible person
fatemeh zeynali
Street address
City
sabzevar
2
Recruitment center
Name of recruitment center
sabzevar Vasei Hospital
Full name of responsible person
fatemeh zeynali
Street address
City
sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Sabzevar University of Medical Sciences
Full name of responsible person
Moosa Reza Tadayonfar
Street address
Building number one, next to the police station to SHahroud road, The School of Nursing and Midwifery, University of Medical Sciences and Health Services, sabzevar
City
sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
fatemeh.zeynali
Position
Student of MSc Nursing
Other areas of specialty/work
Street address
Building number one, next to the police station to SHahroud road, The School of Nursing and Midwifery, University of Medical Sciences and Health Services, sabzevar
City
sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
fatemeh.z134@ yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Abdolghader.Assarodi
Position
PhD Student in Nursing
Other areas of specialty/work
Street address
Building number one, next to the police station to SHahroud road, The School of Nursing and Midwifery, University of Medical Sciences and Health Services, sabzevar
City
sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
assara911@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
fatemeh.zeynali
Position
Student of MSc Nursing
Other areas of specialty/work
Street address
Building number one, next to the police station to SHahroud road, The School of Nursing and Midwifery, University of Medical Sciences and Health Services, sabzevar
City
Sabzevar
Postal code
Phone
Fax
Email
fatemeh.z134@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)