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IRCT20210131050189N1 IRCT 2021-05-13 Shahid Beheshti University of Medical Sciences Effect of Inhalation of Mint Oil on Vital Signs and O2 Saturation Effect of Inhalation of Mint Oil on Vital Signs and O2 Saturation in neurosurgery Patient Hospitalized in Intensive Care Unit 2021-05-16 anticipated 80 Complete https://irct.ir/trial/55984 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Restricted randomization by Random allocation rule will be used. Random allocation will be done with white and black cards. For allocation concealment, Sequentially numbered, opaque envelopes, sealed envelopes will be used. Before the intervention, 40 white cards and 40 black cards are placed in an envelope and taken out, respectively. The order of the removed cards from 1 to 80 is placed on the special envelopes for sampling. With the order of the samples, a special envelope is opened and it is placed in group A or B based on the color of the patient's card. If the card taken out of the envelope is white, the patient is in group A, and if the card is black, the patient is in group B, Blinding description: Two identical medicine bottles are prepared from peppermint extract and a medicine bottle containing distilled water with a colored substance in a sterile form. Placed on them. For aromatherapy in group A, a medicine glass labeled "A" will be used and in group B, a medicine glass labeled "B" will be used. Also, in statistical analysis, blinding will be used, in which the statistical consultant will be unaware of the two groups of intervention and control, and the two groups will be introduced to him as groups A and B. 2 Condition 1: neurosurgery Patient Hospitalized in Intensive Care Unit. Condition 2: neurosurgery Patient Hospitalized in Intensive Care Unit. Condition 3: neurosurgery Patient Hospitalized in Intensive Care Unit. Intervention 1: Intervention group: 0.2 ml of 10% peppermint extract with 10 ml of distilled water will be nebulized through the nebulizer mask for 15 minutes with oxygen. Intervention 2: Control Group: 0.2 ml of green distilled water with 10 ml of distilled water will be nebulized through the nebulizer mask for 15 minutes with oxygen. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: After defending the dissertation and publishing the article To whom: For researchers working in academic and scientific institutions Conditions: For further research Where to obtain: By email of the co responder author: raziehghafouri@gmail.com How to obtain: Ask the responsible author in an email. Mention the purpose and location of the research in the email. The co responder author will be answered within two weeks Comments:
public Raziyeh Ghafouri
Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Opposite to Rajaee Heart Hospital, Tehran
tehran Iran (Islamic Republic of) 1996835119 +98 21 8820 2520 raziehghafouri@gmail.com Shahid Beheshti University of Medical Sciences scientific Raziyeh Ghafouri
Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Opposite to Rajaee Heart Hospital, Tehran
tehran Iran (Islamic Republic of) 1996835119 009888202520 raziehghafouri@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age over 18 years and under 50 years No history of allergy to a particular substance- Awareness level above 13 according to Glasgow criteria No history of addiction No underlying disease (diabetes, high blood pressure, chronic heart failure, respiratory failure and kidney failure)- No endotracheal tube or 24 hours after extubation Stability of vital signs at least 12 hours before the extubation 18 years 50 years Both Any sudden change in vital signs and general condition during the intervention that is a sign of intolerance to aromatherapy. Any change in the patient's breathing pattern during the intervention Change in the patient's medication during the intervention up to 6 hours after the intervention Complications after surgery such as severe pain, active bleeding, or infection S06.4X S06.5X S06.2 Epidural hemorrhage Traumatic subdural hemorrhage Diffuse traumatic brain injury Treatment - Other Placebo Intervention group: 0.2 ml of 10% peppermint extract with 10 ml of distilled water will be nebulized through the nebulizer mask for 15 minutes with oxygen. Control Group: 0.2 ml of green distilled water with 10 ml of distilled water will be nebulized through the nebulizer mask for 15 minutes with oxygen. Blood pressure. Timepoint: 6 hours after intervention. Method of measurement: blood pressure monitoring. O2 Saturation. Timepoint: 6 hours after intervention. Method of measurement: pulse oximetry. Pulse rate. Timepoint: 6 hours after intervention. Method of measurement: heart rate monitoring. Respiratory rate. Timepoint: 6 hours after intervention. Method of measurement: respiratory rate monitoring. no thing Approved 2021-05-02 School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of Medical Sciences (Biomedic Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Opposite to Rajaee Heart Hospital, Tehran Tehran Tehran Iran (Islamic Republic of)