160 A.Hajibagheri et al Complementary Therapies in Clinical Practice 20(2014)159-163 potential effect on the quality of sleep among patients.However,to we used Persian version of PSOL.Validation of the Persian version the best of our knowledge,this effect has not been examined yet. has yielded satisfactory results.Cronbach's alpha coefficient was Accordingly,we conducted this study aiming at investigating the 0.77 and corrected item-total correlations ranged from 0.30 to 0.75 effect of Rosa damascene aromatherapy on sleep quality among for the seven component scores of the PSQI [171. patients hospitalized in CCU. 2.5.Intervention 2.Methods At the start of the study (in the second day of hospitalization) 2.1.Design we asked all the patients in both study groups to complete the PSQl Moreover,we gathered patients'demographic and clinical data by This was a non-blind randomized controlled trial conducted in referring to their medical records.The onset of intervention was in September-December 2013.The study setting included the two the second night of hospitalization.In the control group,patients CCUs of a teaching hospital affiliated to Kashan University of received the sleep care routinely provided in the study setting.The Medical Sciences,Kashan,Iran. routine sleep care included of reducing environmental noises decreasing indoor lighting level,and providing nursing care during 2.2.Participants daytime to avoid interrupting patients'sleep for nighttime care provision.Patients in the experimental group received routine The study population comprised all patients hospitalized in the sleep care as well as aromatherapy.Each night,we applied three study setting.The inclusion criteria were being oriented to time drops of Rosa damascene (Barijessence Co.,Kashan,Iran)to a piece place,and person,having a cardiac ejection fraction of at least 40% of paper towel and attached the towel to the side of each patient's having no known sleep-disturbing diseases(such as rheumatoid pillow.The towel remained in place for eight hours(22:00-06:00). arthritis and migraine),having no known sleep disorders (as In the morning of the fourth day of the study (i.e.after the third mentioned by participants),having no history of asthma,having no aromatherapy session),we asked patients in both groups to fill out allergy to flowers,aromas,and herbal essences,having no history of PSQI again. orthopnea or nocturnal respiratory disorders and receiving no medical treatment during sleeping hours (22:00-06:00).The 2.6.Data analysis exclusion criteria included patient's reluctance to remain in the study,developing allergy to aromatherapy,developing orthopnea Study data were analyzed by using the Statistical Package for or any other nocturnal respiratory problems.decreased con- Social Sciences(SPSS.v.11.5).The matching of the study groups sciousness,cardiac arrest and using over-the-counter tranquilizers regarding demographic and clinical data was assessed by using the or hypnotic-sedative agents. independent-samples t and the Chi-square tests.Moreover,we The study sample size was calculated using the results of a local used the Kolmogorov-Smirnov test for testing the normality of the study conducted by Daneshmandi et al.(2012).Based on the results study main variable (the sleep quality scores).The results of this of Daneshmandi et al.(2012).S1,S2,u1,and u2 were respectively test revealed that the scores of PSQl and its domains did not have a equal to 0.70,0.40,1.60,and 0.60.Accordingly,with a type I error normal distribution.Accordingly.we used the non-parametric probability of 0.05 and a power of 0.80,the sample size was Wilcoxon signed-rank and Mann-Whitney U tests respectively determined to be fifteen patients for each group.However,for for within-and between-groups comparisons.The level of signifi- compensating probable attritions and achieving more reliable re- cance was set at below 0.05. sults,we recruited 30 patients for each group.Patients were recruited to the study by using the convenience sampling method. 2.7.Ethical considerations 2.3.Randomization The Ethics Committee of Kashan University of Medical Sciences approved the study.Also,permissions were obtained from the We randomly assigned the study participants to the study hospital and the wards authorities.We informed the study partic- groups by using the permuted block randomization technique. ipants about the aim and the course of the study,being free to Primarily,the six-block size of four was formed.Then,the sequence participate in the study,being free to withdraw from the study at of blocks was determined using a table of random numbers.All the any stage,confidentiality of personal information and the lack of study interventions were implemented by the same researcher adverse effects of aromatherapy.Then we obtained a written who was not blind to the study. informed consent from them. 2.4.Outcome measures 3.Findings The study instrument comprised two parts including a de- Thirty patients were enrolled in each group (Fig.1).The mean mographic questionnaire and the Pittsburgh Sleep Quality Index. and standard deviation of participants'age in the experimental and The demographic questionnaire consisted of questions about par- the control groups were 61.40+11.64 and 63.9+10.23 years, ticipants'demographic and clinical data (including age,gender, respectively.Most of the participants were married(88.3%).literate marriage,employment,educational status,previous history of (61.70%),and male (58.30%).The medical diagnosis for most par- hospitalization,and medical diagnosis).The Pittsburgh Sleep ticipants was acute coronary syndrome(66.70%).Most of the par- Quality Index (PSQl)is a self-report questionnaire developed for ticipants(68.30%)had been previously hospitalized for at least one evaluating sleep quality [17.18].The PSQI consists of 7 components: time.The statistical analysis showed no significant differences in subjective sleep quality,sleep latency,sleep duration,habitual age,gender,marriage,employment,educational status,previous sleep efficiency,sleep disturbances,use of sleeping medications history of hospitalization,and established medical diagnosis be- and daytime dysfunction.The score for each component ranges tween the two groups (P value 0.05:Table 1). from 0 to 3.resulting in a total PSQI score of 0-21.Higher scores The Wilcoxon signed-rank test showed that in the experimental represent lower sleep quality and vice versa[19-21.In this study group,the mean scores of the sleep latency,the sleep duration,thepotential effect on the quality of sleep among patients. However, to the best of our knowledge, this effect has not been examined yet. Accordingly, we conducted this study aiming at investigating the effect of Rosa damascene aromatherapy on sleep quality among patients hospitalized in CCU. 2. Methods 2.1. Design This was a non-blind randomized controlled trial conducted in SeptembereDecember 2013. The study setting included the two CCUs of a teaching hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran. 2.2. Participants The study population comprised all patients hospitalized in the study setting. The inclusion criteria were being oriented to time, place, and person, having a cardiac ejection fraction of at least 40%, having no known sleep-disturbing diseases (such as rheumatoid arthritis and migraine), having no known sleep disorders (as mentioned by participants), having no history of asthma, having no allergy to flowers, aromas, and herbal essences, having no history of orthopnea or nocturnal respiratory disorders and receiving no medical treatment during sleeping hours (22:00e06:00). The exclusion criteria included patient’s reluctance to remain in the study, developing allergy to aromatherapy, developing orthopnea or any other nocturnal respiratory problems, decreased con￾sciousness, cardiac arrest and using over-the-counter tranquilizers or hypnotic-sedative agents. The study sample size was calculated using the results of a local study conducted by Daneshmandi et al. (2012). Based on the results of Daneshmandi et al. (2012), S1, S2, m1, and m2 were respectively equal to 0.70, 0.40, 1.60, and 0.60. Accordingly, with a type I error probability of 0.05 and a power of 0.80, the sample size was determined to be fifteen patients for each group. However, for compensating probable attritions and achieving more reliable re￾sults, we recruited 30 patients for each group. Patients were recruited to the study by using the convenience sampling method. 2.3. Randomization We randomly assigned the study participants to the study groups by using the permuted block randomization technique. Primarily, the six-block size of four was formed. Then, the sequence of blocks was determined using a table of random numbers. All the study interventions were implemented by the same researcher who was not blind to the study. 2.4. Outcome measures The study instrument comprised two parts including a de￾mographic questionnaire and the Pittsburgh Sleep Quality Index. The demographic questionnaire consisted of questions about par￾ticipants’ demographic and clinical data (including age, gender, marriage, employment, educational status, previous history of hospitalization, and medical diagnosis). The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire developed for evaluating sleep quality [17,18]. The PSQI consists of 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. The score for each component ranges from 0 to 3, resulting in a total PSQI score of 0e21. Higher scores represent lower sleep quality and vice versa [19e21]. In this study we used Persian version of PSQI. Validation of the Persian version has yielded satisfactory results. Cronbach’s alpha coefficient was 0.77 and corrected item-total correlations ranged from 0.30 to 0.75 for the seven component scores of the PSQI [17]. 2.5. Intervention At the start of the study (in the second day of hospitalization), we asked all the patients in both study groups to complete the PSQI. Moreover, we gathered patients’ demographic and clinical data by referring to their medical records. The onset of intervention was in the second night of hospitalization. In the control group, patients received the sleep care routinely provided in the study setting. The routine sleep care included of reducing environmental noises, decreasing indoor lighting level, and providing nursing care during daytime to avoid interrupting patients’ sleep for nighttime care provision. Patients in the experimental group received routine sleep care as well as aromatherapy. Each night, we applied three drops of Rosa damascene (Barijessence Co., Kashan, Iran) to a piece of paper towel and attached the towel to the side of each patient’s pillow. The towel remained in place for eight hours (22:00e06:00). In the morning of the fourth day of the study (i.e. after the third aromatherapy session), we asked patients in both groups to fill out PSQI again. 2.6. Data analysis Study data were analyzed by using the Statistical Package for Social Sciences (SPSS, v. 11.5). The matching of the study groups regarding demographic and clinical data was assessed by using the independent-samples t and the Chi-square tests. Moreover, we used the KolmogoroveSmirnov test for testing the normality of the study main variable (the sleep quality scores). The results of this test revealed that the scores of PSQI and its domains did not have a normal distribution. Accordingly, we used the non-parametric Wilcoxon signed-rank and ManneWhitney U tests respectively for within- and between-groups comparisons. The level of signifi- cance was set at below 0.05. 2.7. Ethical considerations The Ethics Committee of Kashan University of Medical Sciences approved the study. Also, permissions were obtained from the hospital and the wards authorities. We informed the study partic￾ipants about the aim and the course of the study, being free to participate in the study, being free to withdraw from the study at any stage, confidentiality of personal information and the lack of adverse effects of aromatherapy. Then we obtained a written informed consent from them. 3. Findings Thirty patients were enrolled in each group (Fig. 1). The mean and standard deviation of participants’ age in the experimental and the control groups were 61.40 11.64 and 63.9 10.23 years, respectively. Most of the participants were married (88.3%), literate (61.70%), and male (58.30%). The medical diagnosis for most par￾ticipants was acute coronary syndrome (66.70%). Most of the par￾ticipants (68.30%) had been previously hospitalized for at least one time. The statistical analysis showed no significant differences in age, gender, marriage, employment, educational status, previous history of hospitalization, and established medical diagnosis be￾tween the two groups (P value > 0.05; Table 1). The Wilcoxon signed-rank test showed that in the experimental group, the mean scores of the sleep latency, the sleep duration, the 160 A. Hajibagheri et al. / Complementary Therapies in Clinical Practice 20 (2014) 159e163