Protocol summary

Summary
The purpose of this study is to examine the effect of ear acupressure on pain, anxiety and severity of nausea in patients candidate for appendectomy. In this clinical trial, 72 subjects will be selected. Samples based on a random allocation method (Balanced Blocking Randomization) will be divided into 3 groups: placebo, control and intervention. Inclusion criteria include: confirmed appendicitis diagnosed by a surgeon, Patient's consent to participate in this study, not taking pain relief, the absence of lesion or rash at the site of acupressure exercise and ability to report symptoms. Exclusion criteria include: taking pain relief, Unwillingness to continue cooperation and any complications or other medical problems that make the intervention impossible. After confirmation of appendicitis diagnosed by a surgeon in all three groups pain, anxiety and severity of nausea will be measured. Then the intervention group will be received acupressure for 15 minutes in the thalamus point in the ear. Placebo group will be received acupressure for 15 minutes on adjacent points that are called sham points. In the control group no intervention on patients will be made. Again pain, anxiety and severity of nausea in all three groups, at 15 and 45 minutes, will be monitored. All three groups will receive routine therapy. Massage in males and females will be performed by male and female nurses respectively. The main variable is the acupressure that its effect will be evaluated on pain, anxiety and severity of nausea.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014010416049N1
Registration date: 2014-05-03, 1393/02/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-05-03, 1393/02/13
Registrant information
Name
Arezoo Davarinia Motlagh Ghochan
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 3028
Email address
davarinia.a@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
This study will be performed with personal expenses and will be sponsored by the research deputy of the Gonabad University of Medical Sciences
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of ear acupressure on pain, anxiety and severity of nausea in patients candidated for appendectomy: A three groups randomized clinical trial
Public title
effect ear acupressure on pain, anxiety and nausea in patients candidate for appendectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Confirmed appendicitis diagnosed by a surgeon 2- The patient is not candidate for emergency appendectomy 3- Patient's consent to participate in this study 4- Without any complications and other medical problems that cause pain, anxiety and nausea 5- Lack of lesion or rash at the site of ear acupressure exercise 6- Consciousness and the ability to report symptoms 7- Not taking pain relief Exclusion criteria: 1- Unwillingness to continue cooperation 2- The clinical condition of the patient that any intervention would be impossible 3- taking pain relief during the intervention period
Age
From 10 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
None
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Next to the Asian Road, Gonabad, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Approval date
2013-12-18, 1392/09/27
Ethics committee reference number
GMU.REC.1392.20

Health conditions studied

1

Description of health condition studied
Appendicitis
ICD-10 code
k35.8
ICD-10 code description
Acute appendicitis, other and unspecified

Primary outcomes

1

Description
Anxiety
Timepoint
Immediately before, after and half an hour after the intervention
Method of measurement
Visual anxiety scale

2

Description
Pain
Timepoint
Immediately before, after and half an hour after the intervention
Method of measurement
Visual analog scale

3

Description
Severity of nausea
Timepoint
Immediately before, after and half an hour after the intervention
Method of measurement
Measure of visual simulation for nausea

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will receive acupressure for 15 minutes in the thalamus point in the ear.
Category
Treatment - Other

2

Description
Placebo group will be received acupressure for 15 minutes on adjacent points that are called sham points
Category
Treatment - Other

3

Description
In the control group no intervention on patients will be made
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Beydokht 15 Khordad Hospital
Full name of responsible person
Arezoo Davarinia Motlagh Ghochan
Street address
Next to the Asian Road, Gonabad University of Medical Sciences
City
Gonabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
chancellor for research, Gonabad University of Medical Sciences
Full name of responsible person
Doctor Ali Mohammadpour
Street address
Next to the Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
chancellor for research, Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Arezoo Davarinia Motlagh Ghochan
Position
MSC Student in Critical Care Nursing
Other areas of specialty/work
Street address
Next to the Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 53 3722 3028
Fax
Email
davarinia.a@gmu.ac.ir; a.davarinia@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Chancellor for research, Gonabad University of Medical Sciences
Full name of responsible person
Doctor Ali Mohammadpour
Position
PhD of Nursing - Associate Professor
Other areas of specialty/work
Street address
Next to the Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 53 3725 3884
Fax
+98 53 3725 3884
Email
dr.mohammadpour@gmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Arezoo Davarinia Motlagh Ghochan
Position
MSC Student in Critical Care Nursing
Other areas of specialty/work
Street address
Next to the Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 53 3722 3028
Fax
Email
a.davarinia@yahoo.com; davarinia.a@gmu.ac.ir
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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