Determining the Effect of Inhalation Therapy on Essential Oil of Damask Rosea on the Fatigue and Anxiety of Cancer Patients Under Chemotherapy
Design
This clinical trial was conducted with a control group at Khansaria Hospital in Arak. 64 cancer patients undergoing chemotherapy were selected based on the inclusion criteria by simple random sampling and the random number block using letters A and B to 2 groups: Inhaled aromatherapy (32 patients) and control group (32) .
Settings and conduct
Khansari Hospital in Arak.
Participants/Inclusion and exclusion criteria
Patients with head and neck cancer
Intervention groups
The fatigue and anxiety levels of the patients were assessed by a researcher before intervention using the BFI and Spielberger questionnaires. by the assistant Using a pipette, distilled water was dropped on a 10 × 10 cm gauze which was attached to the collar of the patient's shirt, about 20 cm from their nose.The patients in the intervention group in addition to the usual nursing care, inhaled 5 drops of damask rose essential oil 40% Prepared by the pharmacist, for 20 min, for 3 day consecutive , while In the control group, addition to the usual nursing care, the patients inhaled five drops of distilled water as placebo through the same procedure. researcher measured Patients' anxiety 20 minutes after intervention by using the Spielberger's questionnaire .researcher measured Patients' fatigue in 30 and 60 minutes after intervention by using the BFI questionnaire.
Main outcome variables
fatigue and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111015007803N3
Registration date:2018-08-29, 1397/06/07
Registration timing:retrospective
Last update:2018-08-29, 1397/06/07
Update count:0
Registration date
2018-08-29, 1397/06/07
Registrant information
Name
Faraz Mojab
Name of organization / entity
Shahid Beheshty University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0061
Email address
sfmojab@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-20, 1397/01/31
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
2018-06-18, 1397/03/28
Actual recruitment end date
2018-08-19, 1397/05/28
Trial completion date
empty
Scientific title
The Effects of Inhalation of Rosa Damascene Essential Oil on Fatigue and Anxiety among Cancer Patients Receiving Chemotherapy
Public title
The Effects of Inhalation of Rosa Damascene Essential Oil on Fatigue and Anxiety among Cancer Patients Receiving Chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age greater than 18 and less than 70 years
Cancer patients with at least one chemotherapy course with a 21 day interval from the last session.
Detect stage 2, 3, and 4 of all cancers other than head and neck and lung with the opinion of the relevant physician.
Full vigilance
No history of cigarette and drug addiction
Earning a score higher than 20 after responding to the Spielberger questionnaire in the pre-test
Non-use of benzodiazepines, tranquillizers and opioids during intervention
Without a history of migraine and chronic headaches
Non-impaired sense of smell (without obstruction and nasal congestion) and healthy sense of smell) through smelling of alcohol).
Inability of the patient to answer questions (in terms of physical and mental status)
lack of patient psychiatric problems (hospitalization or other medical treatment is not due to mental disorders).
Stable and stable hemodynamic status
Not having a history of allergy to the smell of herbs and any scent or fragrance
Not having respiratory diseases
The desire to participate in research
Do not use any other scent during the study
Exclusion criteria:
Patients with head and neck cancer
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
64
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The method of sampling in this study was simple random sampling. How to place the selected samples in the test and control group based on the random number block method. From the first patient, one of the letters A and B was randomly selected. The first patient in the experimental group and the second patient in the control group were placed and then the patients were placed in the test and control groups, respectively. 32 patients in the experimental group and 32 patients in the control group were considered.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial in which patients, who measure the outcomes of the study (the researcher), are unaware of how the patients received the intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Islamic Azad University, Tehran Medical Branch
Street address
Shariati St., Khaghani St. - Islamic Azad University, Tehran Medical Sciences
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2017-07-26, 1396/05/04
Ethics committee reference number
IR.IAU.TMU.REC.1396.68
Health conditions studied
1
Description of health condition studied
People with cancer under chemotherapy
ICD-10 code
C80.9
ICD-10 code description
Malignant neoplasm, unspecified
Primary outcomes
1
Description
Fatigue of patients with cancer under chemotherapy
Timepoint
Before the intervention and 30, 60 minutes after the intervention for three consecutive days
Method of measurement
Standard Fatigue Fatigue Questionnaire (BFI)
2
Description
Anxiety in patients with cancer under chemotherapy
Timepoint
Before the intervention and 20 minutes after the intervention for three consecutive days
Method of measurement
Spilberger Situational Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
The fatigue and anxiety levels of the patients were assessed by a researcher before intervention using the BFI and Spielberger questionnaires. by the assistant Using a pipette, distilled water was dropped on a 10 × 10 cm gauze which was attached to the collar of the patient's shirt, about 20 cm from their nose.The patients in the intervention group in addition to the usual nursing care, inhaled 5 drops of damask rose essential oil 40% Prepared by the pharmacist, for 20 min, for 3 day consecutive , while In the control group, addition to the usual nursing care, the patients inhaled five drops of distilled water as placebo through the same procedure. researcher measured Patients' anxiety 20 minutes after intervention by using the Spielberger's questionnaire .researcher measured Patients' fatigue in 30 and 60 minutes after intervention by using the BFI questionnaire.
Category
Treatment - Other
2
Description
Control group: The fatigue and anxiety levels of the patients were assessed by a researcher before of intervention using the BFI and Spielberger questionnaires. by the assistant Using a pipette, distilled water was dropped on a 10 × 10 cm gauze which was attached to the collar of the patient's shirt, about 20 cm from their nose. In the control group, addition to the usual nursing care, the patients inhaled five drops of distilled water as placebo through the same procedure. researcher measured Patients' anxiety 20 minutes after intervention by using the Spielberger's questionnaire .researcher measured Patients' fatigue in 30 and 60 minutes after intervention by using the BFI questionnaire.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Khansari Hospital
Full name of responsible person
Elham Khosrobeigi
Street address
University Street
City
Arak
Province
Markazi
Postal code
34.1061,49.7134
Email
elhamkhosrobeigi65@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farshad Hashemian
Street address
Shariati St., Khaghani St. - Islamic Azad University, Tehran Medical Sciences
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
iautmu@iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?