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Comparisons between aromatherapy massage with peppermint oil and sweet almond oil on pain, nausea, vomiting and physiological parameters after Laparoscopic Cholecystectomy Surgery

Protocol summary

Summary
The purpose of this single-blind clinical trial study is to compare the effect of aromatherapy massage with peppermint oil and Sweet almond oil on the pain, nausea, vomiting and physiological parameters after laparoscopic cholecystectomy surgery in Razi Hospital in Ahvaz in 2013. The inclusion criteria include: being over 18 years of age, not suffering from motion sickness, motion vertigo, not being a drug addict, not using anticoagulant therapy, No history of eczema, not suffering from dermatitis or psoriasis, scars and burns on the hands and feet. Exclusion criteria include: having acute pain at the time of intervention, withdrawal of the patient from clinical trials and intestinal injury during surgery. The sampling is based on random assignment of subjects to two groups in blocks of 4: 2 intervention groups (each one 30 patients). In the intervention group 1, as soon as the patients experience postoperative pain and nausea, the researcher applies petrissage technique by clockwise circular movements with his middle finger rotating on PC6, LI11 and LI4 points on each hand, as well as SP6, ST36 and LIV3 points on each foot. respectively with 3 drops of peppermint oil and he will do this procedure 5 minutes for each organ. Also in the second group the researcher applies 3 drops of sweet almond oil in the same manner and in the same areas of hand and foot. Then pain, nausea, vomiting and physiological parameters will be checked within 6, 12 and 24 hours after surgery.this intervention will be applied along with all other routine treatment measures for the patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014021914802N2
Registration date: 2014-08-16, 1393/05/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-16, 1393/05/25
Registrant information
Name
Sara Adarvishi
Name of organization / entity
Ahvaz Jondishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1377 7966
Email address
adarvishi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapur University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparisons between aromatherapy massage with peppermint oil and sweet almond oil on pain, nausea, vomiting and physiological parameters after Laparoscopic Cholecystectomy Surgery
Public title
Comparison Between Aromatherapy Massage with Peppermint Oil and Sweet Almond Oil on Pain, Vomiting and Vital Signs after Laparoscopic Cholecystectomy Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Being over 18 years of age; Ability to understand and speak Persian; No history of any previous gastrointestinal disorders; No history of motion sickness; Dizziness and lack of movement; Lack of drug addiction; No use of anticoagulant drugs; No hemorrhagic disease; History of eczema; History of dermatitis or psoriasis, scars and burns on the hands and feet; Failure to participate in the risk of aspiration and the incidence of illus(eg, background radiation, excessive sedation, Anastomosis and receiving) Exclusion criteria: Pain during the intervention; More patients withdrew from participation in the study; Need for blood transfusion in recovery room.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences Ethics Committee
Street address
Ethics Committee, vice-chancellor for research and technology, Jundishapur University of Medical Sciences, Golestan street, Ahvaz
City
Ahvaz
Postal code
15794 - 61357
Approval date
2014-02-17, 1392/11/28
Ethics committee reference number
Ajums.REC.1392.299

Health conditions studied

1

Description of health condition studied
Laparoscopic Cholecystectomy
ICD-10 code
K80.2
ICD-10 code description
Calculus of gallbladder without cholecystitis

Primary outcomes

1

Description
pain
Timepoint
0,6,12,24 hours after intervention
Method of measurement
Visual Analog scale

2

Description
Blood pressure
Timepoint
0,6,12,24 hours after intervention
Method of measurement
Portable analog pressure gauge

3

Description
Nausea and Vomitting
Timepoint
0,6,12,24 hours after intervention
Method of measurement
Visual Analog Scale

4

Description
Heart Rte
Timepoint
0,6,12,24 hours after intervention
Method of measurement
Radial Pulse

5

Description
Respiratory rate
Timepoint
0,6,12,24 hours after intervention
Method of measurement
Observation chest in a minute

Secondary outcomes

empty

Intervention groups

1

Description
For the intervention Group 1:After surgery as the patients experience postoperative pain and nausea, researcher washes and dries her hands and then applies petrissage by clockwise circular movements with his middle finger rotating on PC6, LI11 and LI4 points on each hand, and SP6, ST36, and LIV3 points on each foot respectively with 3 drops of peppermint oil until the patient feels the pressure, and he will do this procedure 5 minutes for each organ. If there is any intravenous catheter, massage on that area of the hand will not be performed
Category
Treatment - Other

2

Description
For Control Group 2: After surgery ,as the patients experience postoperative pain and nausea, the researcher washes and dries her hands and then applies petrissage by clockwise circular movements with his middle finger rotating on PC6, LI11, and LI4 points on each hand as well as SP6, ST36, and LIV3 points on each foot respectively with 3 drops of peppermint oil until the patient feels the pressure ,and he will do this procedure 5 minutes for each organ. If there is any intravenous catheter, massage on that area of the hand will not be performedIf there is any intravenous catheter, massage on that area of the hand will not be performed.For male patients Massage by a collaborator  Training is exactly as Researcher And coincides with the Get expert cam And run for at least 4 patients And has been approved, will be implemented.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Operation Room of Ahvaz Razi Hospital
Full name of responsible person
Sara Adarvishi
Street address
Ahvaz Razi Hospital, front of the Governor, Amaniye street, Ahvaz, Khozestan
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice-chancellor for research and technology of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Ahvaz Jundishapur University of Medical Sciences, vice-chancellor for research and technology, Golestan street, Ahvaz, Khozestan
City
Ahvaz
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 and technology of Ahvaz Jundishapur 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
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Sara Adarvishi
Position
MSc student of nursing education
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, nursing school, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
6143994353
Phone
+98 61 1377 7966
Fax
Email
sara.adarvishi@yahoo.com adarvishi.s@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Sadigheh Fayazi
Position
MSc of nursing education
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, nursing school, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
0
Phone
+98 61 1333 2368
Fax
Email
fayazi-s@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Sara Adarvishi
Position
MSc student of nursing education
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, nursing school, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
6143994353
Phone
+98 61 1377 7966
Fax
Email
sara.adarvishi@yahoo.com adarvishi.s@ajums.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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