]>
IRCT20221205056718N3 IRCT 2024-02-14 Ghoum University of Medical Sciences Investigating the effect of Damask Rose on pain intensity, anxiety and vital signs Effect of inhalation aromatherapy with Damask Rose on Pain severity, anxiety and hemodynamic parameters in patients undergoing cataract surgery with local anesthesia 2024-04-06 anticipated 152 Complete https://irct.ir/trial/75373 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients who are eligible for the study are entered into the study using the available method and are randomly assigned to two intervention and control groups using the block method (blocks of four and with an allocation ratio of 1:1 using a random number table). . For example, the first four participants enrolled form the first block and the next four form the next block, and so randomization occurs within blocks, so with blocks of size four there are six possible patterns: AABB, ABAB, ABBA , BAAB, BABA, and BBAA, each block is randomized based on one of these six patterns, and the patterns are chosen randomly and generally independently from block to block, Blinding description: In this study, before starting the research, the participants will not be aware of the objectives of the research, and after the study, the objectives of the research will be explained to them, and if the patient does not want to use the scent, he will be excluded from the study. The two nurses who complete the evaluation questionnaires will not know about the two control and intervention groups due to the spread of low-scented smell and the use of aromatic gas inside their masks. The researcher will conduct the intervention and monitor the data recording process. N/A Anxiety. Intervention 1: Intervention group: The pad impregnated with Damask Rose is fixed inside the oxygen mask using glue, and the patient will also smell Damask Rose during the surgery along with receiving oxygen, which is done routinely. Damask Rose (group A) and placebo (group B) will be administered for 20 minutes. Intervention 2: Control group: The intervention will be to fix the pad soaked in normal saline inside the oxygen mask using glue, and the patient will also smell normal saline during the surgery along with receiving oxygen, which is done routinely. Yes - There is a plan to make this available What will be shared: Effect of inhalation aromatherapy with Damask Rose on Pain severity, anxiety and hemodynamic parameters in patients undergoing cataract surgery with local anesthesia When: The second half of 2024 To whom: There is no restriction on access to the results Conditions: There are no restrictions after de-identifying people Where to obtain: hossein sharafi email:h_sharafi68@yahoo.com hsharafi@muq.ac.ir tell:00989173596990 How to obtain: The request for the data that is irrefutably identified will be made through the e-mail introduced by the researcher, and the request will be reviewed in less than 10 days and the requested data will be provided to the requester. Comments:
public Hossein sharafi
Qom University of Medical Sciences, Pardisan
Qom Iran (Islamic Republic of) 3749153434 009892531971155 h_sharafi68@yahoo.com Ghoum University of Medical Sciences scientific Hossein sharafi
Qom University of Medical Sciences, Pardisan
Qom Iran (Islamic Republic of) 3749153434 +98 25 3197 1155 h_sharafi68@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Ability to communicate Insensitivity to herbal medicines No drug addiction and alcohol addiction No mental disorder No olfactory disorder Not smoking Over 60 years of age The same anesthesiologist and surgeon The amount of fluo-oxygen is the same in all samples 60 years no limit Both Use of other herbal medicine by the patient Respiratory and allergic problems The patient's unwillingness to continue to cooperate Using more or less than normal amount of oxygen Lack of consciousness of the patient during surgery and discharge of the patient before the end of the study F41.1 Generalized anxiety disorder Treatment - Other N/A Intervention group: The pad impregnated with Damask Rose is fixed inside the oxygen mask using glue, and the patient will also smell Damask Rose during the surgery along with receiving oxygen, which is done routinely. Damask Rose (group A) and placebo (group B) will be administered for 20 minutes. Control group: The intervention will be to fix the pad soaked in normal saline inside the oxygen mask using glue, and the patient will also smell normal saline during the surgery along with receiving oxygen, which is done routinely. Pain associated with cataract surgery. Timepoint: Before the intervention, immediately after the intervention and 15 minutes after leaving the operating room. Method of measurement: VAS scale. Hemodynamic parameters. Timepoint: During the surgical procedure at the same time as aromatherapy, the changes in hemodynamic symptoms (blood pressure-heart rate) of the patient are recorded every 5 minutes. Method of measurement: Digital heart monitoring system. Ghoum University of Medical Sciences Approved 2023-10-02 Research Ethics Committees of Qom University of Medical Sciences Operating room department, Paramedical faculty, Qom University of Medical Sciences, university campus Qom Ghoum Iran (Islamic Republic of)