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IRCT20140721018550N8 IRCT 2020-01-28 Semnan University of Medical Sciences ٍEffects of Aromatherapy with Melissa Officinalis L. on Anxiety --- Effects of Aromatherapy with Melissa Officinalis L. on Anxiety of Patients candidate for coronary angiography and their spouses 2020-02-04 anticipated 72 Complete https://irct.ir/trial/43184 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: -----------, Randomization description: To ensure matching between the two groups as well as to achieve a completely random and balanced assignment, we will use a randomized classification using Stratified permuted block randomization. Individuals are then divided into two stratum of age 18-45 years and over 45 years, and for each class a separate random assignment is continued until the sample size is reached. For random assignment in each class based on different sequences of two methods A (intervention) and B (control), 6 blocks are defined and numbered from left to right from 1 to 6. Then using 1 to 6 random blocks of blocks are randomly selected. (Numbers 0, 7, 8 and 9 are not decided). Thus, the assignment type is determined from left to right, respectively. Since we need 36 pairs in each group, we have to randomly select the block 9 times for that class). 3 Anxiety. Intervention 1: Intervention group 1: Participants will inhale 3 drops of 1% essence of lemon balm on a cotton ball attached to the collar for 20 minutes in sitting position.Then Immediately after this time, State anxiety and their physiological indices will be measured and recorded with same instruments. Intervention 2: Intervention group 2: Participants will inhale 3 drops of 1% essence of lemon balm on a cotton ball attached to the collar for 20 minutes in sitting position.Then Immediately after this time, State anxiety and their physiological indices will be measured and recorded with same instruments. Intervention 3: Control group1: Participants will inhale 3 drops of sterile water on a cotton ball attached to the collar for 20 minutes in sitting position.Then Immediately after this time, State anxiety and their physiological indices will be measured and recorded with same instruments. Intervention 4: Control group 2: Participants will inhale 3 drops of sterile water on a cotton ball attached to the collar for 20 minutes in sitting position.Then Immediately after this time, State anxiety and their physiological indices will be measured and recorded with same instruments. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is possible to share data at the end of study by direct contact.
public Nayyereh Raiesdana
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th Kilometer of Damghan road, Semnan, Iran
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4190 nr_dana@semums.ac.ir Semnan University of Medical Sciences scientific Nayyereh Raiesdana
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th Kilometer of Damghan road, Semnan, Iran
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4190 nr_dana@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Literacy at least end of elementary education Being married No previous history of coronary angiography No olfactory deficiency No previous history of asthma and allergies No addiction 18 years no limit Both Use of sedatives or anxiolytic drugs Use of any perfume and fragrance Severe changes in vital signs or medical condition F09 Mental disorders due to known physiological conditions Prevention Prevention Placebo Placebo Intervention group 1: Participants will inhale 3 drops of 1% essence of lemon balm on a cotton ball attached to the collar for 20 minutes in sitting position.Then Immediately after this time, State anxiety and their physiological indices will be measured and recorded with same instruments. Intervention group 2: Participants will inhale 3 drops of 1% essence of lemon balm on a cotton ball attached to the collar for 20 minutes in sitting position.Then Immediately after this time, State anxiety and their physiological indices will be measured and recorded with same instruments. Control group1: Participants will inhale 3 drops of sterile water on a cotton ball attached to the collar for 20 minutes in sitting position.Then Immediately after this time, State anxiety and their physiological indices will be measured and recorded with same instruments. Control group 2: Participants will inhale 3 drops of sterile water on a cotton ball attached to the collar for 20 minutes in sitting position.Then Immediately after this time, State anxiety and their physiological indices will be measured and recorded with same instruments. Anxiety. Timepoint: Before and after intervention. Method of measurement: Spielberger state-trait anxiety inventory(STAI) Scale. Systolic and diastolic blood pressure. Timepoint: Before and after intervention. Method of measurement: Non-invasive blood pressure measurement with Monitoring SAADAT. Pulse rate. Timepoint: Before and after intervention. Method of measurement: Monitoring SAADAT. O2 Saturation. Timepoint: Before and after intervention. Method of measurement: Pulse Oximeter Monitoring SAADAT. Body temperature. Timepoint: Before and after intervention. Method of measurement: Digital Tympanic Thermometer (Beurer Mark). Semnan University of Medical Sciences Approved 2019-10-22 Ethics Committee of Semnan University of Medical Sciences Semnan University of Medical Sciences, Basij Bolverd, Semnan, Iran Semnan Semnan Iran (Islamic Republic of)