This semi-experimental clinical trial was conducted on elderly patients undergoing knee replacement surgery admitted to orthopedic surgery departments in the Moheb Mehr and Shafa Yahyaian hospitals of Tehran, Iran. The sample size was estimated at 80 (40 in the case group and 40 in the control group) at a significant level of 0.05 and test power of 80%, and assuming d = 1.5 for the effect of aromatherapy with
R. damascena on the severity of anxiety to obtain statistically significant effect of the aromatherapy program. It should be noted that the standard deviation was calculated 2.4 in a similar study by Braden et al. in 2009 (
3).
The inclusion criteria were no history of asthma and allergy to R. damascena, no psychiatric disorders (just psychosis, dementia, and delirium), non-use of alcohol and drugs, healthy sense of smell, no history of migraine and chronic headaches. The exclusion criteria were the lack of willingness to continue cooperation in the process of clinical practice, symptoms of respiratory allergy during the study, and elderly patients who were admitted to the ICU for more than 24 hours because they may have hemodynamic problems or hemorrhage, which is an exclusion criterion.
The data collection tool was the demographic profile form that was completed by interviewing and using the patient records at the beginning of the study. The scientific validity of the demographic form was also determined by the content validity method using the personal opinions of five faculty members of the School of Nursing and Midwifery at Iran University of Medical Sciences. The final revision was made after using the comments, suggestions, and the final approval of the Research and Ethics Committee. The instrument for measuring anxiety was the Visual Analogue scale for anxiety (VAS-A), which is a 100-millimeter ruler that was used by Kindler et al. (
12) in 2000 to investigate the anxiety of patients before surgery and to determine anxiety and fear of anesthesia. Facco et al. (
13) in 2013 validated the VAS tool for measuring anxiety. The results suggest a high correlation between the Visual Analogue scale for anxiety and the State-Trait Anxiety inventory (STAI), which can be a good tool for measuring anxiety.
The researcher contacted by telephone numbers from each of the relevant departments in order to know the day of operation and the patient’s arrival time to the department, as well as obtained the necessary information from the nurse or head nurse about the number of elderly patients undergoing knee replacement surgery, the date of surgery and the patient’s arrival time to the department. The samples were collected using convenience sampling method; so the studied elderly who met inclusion criteria were subjected to one of the two control and case groups randomly according to the hospitals (Shafa Yahyaian Hospital for case group and Moheb Mehr Hospital for control group) and flipping coin (
Figure 1).
The process of the study according to the consort flow diagram
The researcher, after obtaining a written informed consent from the studied elderly, completed the demographic information form through the records and interview. Before the intervention, a pretest was conducted to assess the severity of anxiety using the VAS-A tool, and the intervention was carried out immediately afterward.
The intervention was performed on the second day after the surgery because the patients on the first day of surgery were admitted to the intensive care unit and received a combination of narcotic and non-narcotic drugs, and they were often asleep. The intervention method was that the researcher poured four drops of
R. damascena essential oil (Barij Essence Co., Iran, containing at least 8.5 mg of citronellol (active ingredient) per milliliter) plus 5 mL of normal saline 0.9% on the gauze (10 × 10) and then placed it inside a zipper plastic bag. The elderly in the case group inhaled inside the bags for one to two minutes. The control group inhaled bags containing only gauze impregnated with 5 mL distilled water. The elderly after opening the zipper kept the bags close to the nose (at a distance of one to two centimeters). Then, they began to breathe deeply, as they inhaled with three numbers and exhaled with seven numbers. Exhaling into the bag helps to better smell the
R. damascena essential oil (
7,
14,
15). To prevent the psychological impact of the type of intervention on the results, the patients in the control group were told that there is a need for their cooperation to inhale a harmless substance for conducting research in the field of nursing care from patients undergoing knee replacement surgery. After the first intervention, subsequent interventions were performed three times with half an hour intervals, and the posttest was taken at the end of the fourth intervention; in other words, the whole intervention took place in two hours and four steps.
The “Ethical Committee” approval code is IR.IUMS.REC.1395.9411580004 and this clinical trial registered in the www.irct.ir with a code of (code: IRCT2017030832950N1).