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IRCT20260511069351N1 IRCT 2026-06-04 Gerash University of Medical Sciences Comparison of the effect of aromatherapy with lavender and rose essential oil on pain score, anxiety score and physiological indicators in patients undergoing coronary catheterization through the radial artery Comparison of the effect of aromatherapy with lavender and rose essential oil on pain score, anxiety score and physiological indicators in patients undergoing coronary catheterization through the radial artery: A Randomized Controlled Trial 2026-07-06 anticipated 123 Complete https://irct.ir/trial/90055 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block Randomization Method The method will be accessible. Block randomization will be performed to allocate 123 patients into three groups (41 individuals per group: A, B, C). This method ensures group balance and eliminates allocation prediction. Calculation of block size and number of blocks Block size: 6 individuals (2 per group; small block; multiplier of 3 for complete balance) Number of blocks: total sample size (123) divided by block size (6) equals 20 full blocks (120 individuals) + 1 incomplete block (2 individuals) (each block includes balanced random combinations such as AAB, BCC, or ABC). Blocks will be generated using the R software package (blockrand) and placed in sealed envelopes in Excel. The allocation will be performed independently and blindly. Block selection for intervention will be random. To prevent interference from routine effects, weekly interventions will be carried out. For example, block (ABC) includes three interventions: A intervention and C control in the first week, B intervention in the second week, and C group in the third week. After the third week, the second block will be randomly selected, following the same procedure until the sample size reaches 41 individuals per block. N/A the effect of aromatherapy with lavender and rose essential oil on pain score, anxiety score and physiological indicators in patients undergoing coronary catheterization through the radial artery. Intervention 1: The first Intervention group: inhaled 5 drops of pure lavender essential oil produced by Barij Essence Pharmaceutical Company, Kashan, for 20 minutes. Intervention 2: The second Intervention group: inhaled 5 drops of pure rose essential oil produced by Barij Essence Pharmaceutical Company, Kashan, for 20 minutes. Intervention 3: Control group: inhaled 5 drops of distilled water for 20 minutes. No - There is not a plan to make this available Justification or reason for not sharing IPD is No further information is available
public Seyyedeh Boshra Sheikhahmadi
Sayeh Complex, Hoveyzeh St, Jam-e Jam St
Sanandaj Iran (Islamic Republic of) 6617963753 +98 87 3362 9291 boshra.sh1377@gmail.com Gerash University of Medical Sciences scientific Hajar Haghshenas
Gerash University of Medical Scienes, Daneshjoo Blvd
Gerash Iran (Islamic Republic of) 74417586666 +98 71 5244 8101 haghshenah@gmail.com Gerash University of Medical Sciences Iran (Islamic Republic of) Candidate selection via coronary catheterization through the radial artery Filling out the informed consent form voluntarily Age over 18 years Ability to read and write (literacy) Awareness of the time, place, and person 18 years no limit Both Treatment - Other Treatment - Other Placebo The first Intervention group: inhaled 5 drops of pure lavender essential oil produced by Barij Essence Pharmaceutical Company, Kashan, for 20 minutes The second Intervention group: inhaled 5 drops of pure rose essential oil produced by Barij Essence Pharmaceutical Company, Kashan, for 20 minutes Control group: inhaled 5 drops of distilled water for 20 minutes Pain score. Timepoint: Before, during, 10, 20, 30 minutes after arterial sheath removal. Method of measurement: Visual Analogue Scale. Anxiety score. Timepoint: Before the intervention, before and 30 minutes after arterial sheath removal. Method of measurement: Spielberger State Anxiety Inventory. Physiological indicators (systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, respiratory rate and arterial blood oxygen saturation percentage). Timepoint: Before, during, 10, 20, 30 minutes after arterial sheath removal. Method of measurement: Pouyandegan Rah Saadat company's Vital signs monitoring device. Gerash University of Medical Sciences Approved 2026-04-07 Ethics committee of Gerash University of Medical Sciences Imam Hossein (AS) Blvd, Daneshjoo Blvd, Gerash University of Medical Sciences Gerash Fars Iran (Islamic Republic of)