Determining the effect of two methods of heat therapy and aromatherapy with lavender essence on shoulder pain after laparoscopic cholecystectomy
Design
In this clinical trial, 96 patients who are candidates for laparoscopic cholecystectomy are randomly selected. Participants are randomly divided into two intervention groups based on a Random Digital Table and a control group with parallel groups and blindly on one side.
Settings and conduct
The place of intervention is in the operating room of Al-Zahra and Amin hospitals in Isfahan, The statistical analyst is not aware of the study groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: candidates for laparoscopic cholecystectomy surgery.
Exclusion criteria: allergy to the essence of lavender; patient's intention to leave the intervention at any time.
Intervention groups
In the aromatherapy group , the researcher will pour a drop of oil on the non-absorbent tissue. First, we ask the patient to inhale the essence with 5 deep breaths, and then the non-absorbable tissue soaked in the essence at a distance of 10-15 cm from the patient's nose will attach to his clothes. In the thermotherapy group, we will place a hot water bag with temperature of 90-70 ° C, which is covered with a special towel, under the patient's shoulder for 20 minutes, and the people in the control group will receive routine care. In all 3 groups, before the intervention, the amount of shoulder pain will be evaluated using the Visual Analogue Scale. The patient is asked how much pain he has and then we perform the intervention and the amount of pain is measured and during discharge from recovery and one hour after discharge from the operating room the amount of pain will be evaluated.
Main outcome variables
patients' pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150715023216N9
Registration date:2021-09-06, 1400/06/15
Registration timing:prospective
Last update:2021-09-06, 1400/06/15
Update count:0
Registration date
2021-09-06, 1400/06/15
Registrant information
Name
Said Amini Rarani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3522 6158
Email address
ghadami@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-11, 1400/06/20
Expected recruitment end date
2021-10-12, 1400/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of heat therapy and aromatherapy with lavender essential oil on shoulder pain after laparoscopic cholecystectomy
Public title
The effect of heat therapy and aromatherapy on shoulder pain after laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidate for cholecystectomy surgery by laparoscopic method
Not having other pain focus
Not having smelling problems
No of usage perfumes and colognes
Physicians' approval to ban from entering to research
Not having known mental disorders
Not using cigarettes and narcotic
Non-diabetic patients
Exclusion criteria:
Nausea and vomiting in the patient
Liver and kidney disorders
Allergy to the essence of lavender
Patient's intention to leave the intervention at any time
Use of anticoagolant
pregnancy
Occurrence of medical emergencies conditions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, random sampling will be done and randomly selected individuals who have been admitted to the study, so that among all the people who have the criteria for entering the study according to the Random Digits Table is selected based on the sample size specified. Using 3 cards with letters A, B, C and placing them in sealed envelopes, the patient randomly selects one of them and is assigned to one of the intervention or control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical analyst is unaware of which group each sample belongs to
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University Of Medical Sciences
Street address
Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-08-07, 1400/05/16
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.071
Health conditions studied
1
Description of health condition studied
Cholecystectomy
ICD-10 code
K91.86
ICD-10 code description
Retained cholelithiasis following cholecystectomy
Primary outcomes
1
Description
Pain score in visual analogue scale
Timepoint
Before the intervention, after the intervention, the time of disease awareness in the Post-Anesthesia Care Unit, when discharge from the Post-Anesthesia Care Unit and one hour after discharge from the operating room
Method of measurement
Questionnaire visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: in the aromatherapy group with lavender essential oil, the researcher will pour a drop of oil on the non-absorbable napkin and attach it to the collar of the sample with a pin. We want him to inhale the scent for 2 minutes with 5 deep breaths and then attach the non-absorbable tissue soaked in essential oil, which will make the scent comfortable for at least an hour, to the patient at a distance of 10-15 cm from the nose.
Category
Treatment - Drugs
2
Description
Intervention group 2: in the thermotherapy group, we will place a hot water bag with a temperature of 90-70 ° C, which is covered with a special towel, under the patient's shoulder for 20 minutes.
Category
Treatment - Devices
3
Description
Control group: Individuals in the control group receive routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Ahmad Ghadami
Street address
Hazar Jarib Street
City
esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
2
Recruitment center
Name of recruitment center
Ayatollah Kashani hospital
Full name of responsible person
Ahmad Ghadami
Street address
Ayatollah Kashani hospital, Kashani Street, Isfahan city, Isfahan province, iran