Comparison of massage and inhalation aromatherapy with chamomile essential oil on pain caused by insertion of vascular needles in hemodialysis patients.
Comparison of massage and inhalation aromatherapy with chamomile essential oil on pain caused by insertion of vascular needles in hemodialysis patients.
Design
Clinical trial with control group, double-blind, randomized
Settings and conduct
The location of this study is the dialysis center of Ali Ibn Abi Talib Hospital.
Participants/Inclusion and exclusion criteria
Entry criteria: age 18 and above, without communication problems. Regular hemodialysis at least 2 times a week, no eczema and sensitivity to aromatic oils, no loss of sense of smell, having a healthy AVF access with good function, no use of painkillers in the 3 hours before hemodialysis, having a VAS score ≥3, agreeing to Participation in the study, non-entry criteria: in case of having an inefficient fistula, deep venous thrombosis, unsuccessful first attempt at vascular access, unwillingness to participate in the study for any reason, the patient will be excluded from the study.
Intervention groups
Inhalation Group: Patients inhale chamomile essential oil for 10 minutes before the procedure. Aromatherapy Massage Group: Patients receive a massage with diluted chamomile oil on the arm with a fistula, using an exfoliation method, 10 minutes before the procedure (with a sensitivity test conducted 24 hours prior). Simple Massage Group: Patients receive an exfoliation massage with olive oil on the arm with a fistula, 10 minutes before the procedure. Control Group: No massage is performed.
Post-procedure pain will be measured using the VAS scale.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131228015965N23
Registration date:2024-08-19, 1403/05/29
Registration timing:prospective
Last update:2024-08-19, 1403/05/29
Update count:0
Registration date
2024-08-19, 1403/05/29
Registrant information
Name
Majid Kazemi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 7663
Email address
dr.kazemi.n@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of massage and inhalation aromatherapy with chamomile essential oil on pain caused by insertion of vascular needles in hemodialysis patients.
Public title
Comparison of massage and inhalation aromatherapy with chamomile essential oil on pain caused by insertion of vascular needles in hemodialysis patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 and above, without communication problems. Regular hemodialysis at least 2 times a week, no eczema and sensitivity to aromatic oils, no loss of sense of smell (as a neurological defect, etc.), having a healthy AVF access with good function, no painkillers in the 3 hours before hemodialysis, Having a VAS score ≥3, agreeing to participate in the study
Exclusion criteria:
Inefficient fistula, deep venous thrombosis, failed first attempt at vascular access, unwillingness to participate in the study for any reason
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
4
In this experimental study, 30 patients will be randomly enrolled in 4 stages (inhalation aromatherapy, massage aromatherapy, simple massage and control).
Randomization (investigator's opinion)
Randomized
Randomization description
It is determined by a simple random method by drawing which intervention the patient will be treated with in each session.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is impossible to completely blind the research participants due to the specific scents of the essential oils used in aromatherapy.
In this study, the pain assessor will be completely blinded to ensure the correctness and accuracy of the assessments. This person will not have any information about the type of treatment that each patient receives and his only task will be to evaluate the pain level of the patients based on their reports. The evaluations will be done by standard pain questionnaires that are completed anonymously and without any reference to the type of treatment. Also, the data analyzer does not know about the names of the groups because the names of the groups will be written in spss software from numbers 1 to 4 and the original names of the groups will not be written.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd
City
rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2024-03-06, 1402/12/16
Ethics committee reference number
IR.RUMS.REC.1402.207
Health conditions studied
1
Description of health condition studied
Pain caused by insertion of vascular needles in hemodialysis patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
pain
Timepoint
Immediately after venipuncture by the nurse
Method of measurement
vas tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the aromatherapy stage, the inhaler pad is impregnated with 3 drops of 30% chamomile essential oil (will be purchased from Zardband, Tehran) and attached to the collar of the patient's clothes, and the patient will inhale it for 10 minutes.
Category
Treatment - Other
2
Description
Control group: In the simple massage stage, which is performed as a control of the aromatherapy massage stage, massage with 1 cc of olive oil will be performed for ten minutes in the fistula arm where there is no fistula.
Category
Other
3
Description
Intervention group: In the aromatherapy massage phase, aromatherapy massage solution (2%) using 49 cc of olive oil (because olive oil has no therapeutic value) (35). And 1 cc of chamomile oil in a lightproof oil container with a standard dropper will be prepared daily (45). Before each massage, the hands will be washed with warm water and soap for about 1 to 3 minutes to obtain the necessary flexibility for the massage and provide hand hygiene. The patient is given a comfortable position in his bed. The palm of the masseur will be warmed by rubbing both hands for 10 to 15 times. The therapist will apply one cc of the prepared solution to his hands and perform exfoliation massage (13, 45). Fistula arm (where there is no fistula) will be done for 10 minutes. (a series of light massage movements and caressing in a linear and circular manner with superficial (light) or deep pressure consecutively by both hands of the masseur).
Category
Treatment - Other
4
Description
Control group:in the control phase, no intervention will be done and only the usual and common methods of pain control that are performed in the ward will be performed in these patients.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abitalib Rafsanjan Hospital
Full name of responsible person
Majid Kazemi
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7851656491
Phone
+98 34 3428 0097
Email
dr.kazzemi.m@rums.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vaziri nejad
Street address
Imam Ali Blvd
City
rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
dr.kazzemi.m@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
dr.kazzemi.m@ruma.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
dr.kazzemi.m@rums.a.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
dr.kazzemi.m@rums.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD