The effect of aromatherapy with Citrus aurantium essential oil and foot reflexology on relieve pain in patients with cancer undergoing chemotherapy in hospital
Determining the effect of aromatherapy with spring orange essential oil and plantar reflexology on pain relief in cancer patients undergoing chemotherapy in hospital
Design
Clinical trial with control group, with parallel groups, Double blind, randomized, on 160 randomized patients
Settings and conduct
On cancer patients admitted to Qazvin provincial hospital who are undergoing chemotherapy. Participants and treatment staff will not know about the study group.
Participants/Inclusion and exclusion criteria
Inclusion criteria include having at least 18 years of age, that the person is able to understand Persian and speak Persian and willing to participate in the study, having a pain score of at least 3 based on the VAS scale before the intervention, having alertness and awareness To the place and time, not having any allergies to odor, olfactory disorders, any plague, paresthesia and infectious or bleeding wounds in the legs are other criteria for inclusion in the study.
Intervention groups
The samples will be divided into four groups including three experimental groups and one control group. In the first experimental group, aromatherapy with spring orange will be performed in the second experimental group for half an hour according to the reflexology pain points of the sole of the foot. In the third test group, foot reflexology and aromatherapy with spring orange essential oil will be performed simultaneously on the samples. In the control group, the samples will not receive any type of massage, reflexology or fragrance. It should be noted that all four groups will receive routine hospital care.
Main outcome variables
Pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210412050939N1
Registration date:2021-06-01, 1400/03/11
Registration timing:registered_while_recruiting
Last update:2021-06-01, 1400/03/11
Update count:0
Registration date
2021-06-01, 1400/03/11
Registrant information
Name
Farhad Inanloo tayefeh yaghmorloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3355 8245
Email address
farhad.inanloo@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with Citrus aurantium essential oil and foot reflexology on relieve pain in patients with cancer undergoing chemotherapy in hospital
Public title
The effect of aromatherapy with Citrus aurantium essential oil and foot reflexology on relieve cancer pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be at least 18 years old
The person is able to understand Persian and speak Persian and is willing to participate in the study
Have a pain score of at least 3 based on the VAS scale before the intervention
Platelets above 50,000 in Reflexology groups
Positive olfactory test in aromatherapy groups
Negative sensitivity testing in aromatherapy groups
Exclusion criteria:
Lack of knowledge of time, place and person
Lack of full consciousness
Existence of known mental disorders
Having Deep vein thrombosis
Having coagulation disorders
Acute skin problems and infections and skin lesions
Existence of open wounds in the legs
Existence of recent burns
Existence of fractures
Extensive bruises on the legs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Random randomization will be done by web randomization method and using the website https://www.sealedenvelope.com/.The assignment sequence will be determined by first assigning the letters A, B, C, and D to each of the study groups. The size of the blocks will be eight (twice the number of groups), but the size of the blocks is not said by the researcher so that the person doing the sampling is not aware of it and can not predict how to allocate and in Prevent selection error. After listing almost all possible modes, six blocks, and assigning a number to each of them using a random number table, a number of blocks will be selected to increase the sample size to 160.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the researcher, the pain assessment of the samples before and after the intervention is done by an assistant researcher who will also be unaware of the allocation of study groups. Also, the analyzer will not know about the study groups and will analyze the data only with the codes that are considered for each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2021-04-11, 1400/01/22
Ethics committee reference number
IR.ZUMS.REC.1400.023
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
Z92.21
ICD-10 code description
Personal history of antineoplastic chemotherapy
Primary outcomes
1
Description
Pain score on the VAS scale
Timepoint
Measure the pain score before and one hour after the intervention
Method of measurement
VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first experimental group, aromatherapy with spring orange in such a way that with a dropper of three drops of 10% essential oil of spring orange, Barich essential oil is poured on the gas and placed in a box 30 cm away from the patient's head. From the intervention and one hour after the intervention, it will be completed for three days (that is, 3 times before the intervention and 3 times after the intervention, the pain assessment sheet will be completed).In order to prevent the possible occurrence of allergy to spring orange essential oil in other patients who are present in the ward but are not included in this study, we will try to study in more secluded rooms with a maximum of two beds, as well as for other patients in the room. There are also tests for sensitivity to essential oils, will be performed by the said method.
Category
Other
2
Description
Intervention group: In the second test group, reflexology of the sole of the foot will be performed for half an hour according to the pain points. During this study, each night before the intervention and one hour after the intervention for three nights, the subjects were asked to complete the pain measurement tool.
Category
Other
3
Description
Intervention group: In the third experimental group, plantar reflexology and aromatherapy with spring orange essential oil simultaneously
Category
Other
4
Description
Control group: In the control group, the samples will not receive any kind of massage, reflexology or fragrance and will receive only the usual care of the ward.