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

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 clinical trial with two intervention groups and one control group, without blinding, included 123 patients with random allocation, for randomization process, R package software was used.

Patients who are elective candidates for coronary catheterization through the radial artery refferred to Shahid Boroujerdi Heart Surgery Center at Towhid Hospital in Sanandaj city, Kurdestan province

Inclusion Criteria: ‌ Candidates for elective coronary catheterization via the radial artery Exclusion Criteria: ‌ Allergy to any of the essences used in the study, ‌ Unwillingness to continue cooperation, Any change in participant's clinical condition

Patients will be randomly assigned to one of three groups: lavender, Damask rose aromatherapy, or control. Anxiety scores will be recorded in all three groups before the intervention. 20 minutes before arterial sheath removal, in addition to receiving routine care, patients in intervention groups A and B will receive sterile gauze impregnated with 5 drops of lavender essence or 5 drops of Damask rose essence, respectively. The gauze will be placed on the patient’s chest by the evaluator. In the control group, sterile gauze impregnated with 5 drops of distilled water will be used. ‌After the intervention, physiological indicators and pain scores will be measured and recorded in all three groups during and at 10, 20, and 30 minutes after arterial sheath removal. Anxiety scores will also be assessed in all three groups before and 30 minutes after arterial sheath removal.

Pain score, Anxiety score, Physiological indicators

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.

No further information is available

The full study protocol and final clinical trial report will be available through the IRCT website after publication of the study results and, if applicable, through the journal publishing the study findings. All participant identifiers will be removed to ensure confidentiality.

The study protocol will be available after final registration, and the final study report will be available after publication of the results for at least 5 years.

Researchers, academic staff, students, and other interested individuals may access the published study protocol and final study report.

The shared documents may be used for research, educational, and scientific purposes only. Proper citation of the source is required, and participant confidentiality must be maintained.

Requests for access may be submitted through the IRCT website or by contacting the principal investigator of the study.

Requests will be reviewed by the principal investigator within 14 days. If approved, the requests documents will be provided within 7 days.