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IRCT20170803035479N2 IRCT 2018-11-08 Tehran University of Medical Sciences Comparingcold water with mentol and plantago ovata on thirst and dry mouth Comparing the effect of cold water with mentol and plantago ovata oral care on thirst and dry mouth in intensive care unit patients 2018-10-23 anticipated 132 Complete https://irct.ir/trial/33121 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to balance the number of samples assigned to each of the treatments in 4 intensive care units, permutation block randomization will be used. Based on this method, we assign randomly the number of patients in each block under the intervention of menthol ، plantago psyllium or control. With the help of this intervention allocation method, at the end, the number of patients is equally treated differently and different treatments are equally tested in different parts, Blinding description: In this study, intervention and data collection will be done by researcher. There will be no possibility to blind researcher, so only participants and statistician will not be aware of the control and intervention groups. 0 (exploratory trials) Thirst and dry mouth. Intervention 1: First intervention group (cold water with menthol): Oral washing (mouthwash/ oral care) with cold water and menthol is performed in a two-step process in the morning or evening shift. So that for a maximum of 15 minutes, cold water will be rubbed by the researcher to the lips, tongue and mucus Patients' mouths. and the lips of patients will also be moisturized using menthol. At least 30 minutes later, the washings will be repeated with cold water and menthol. Menthol is prepared with a percentage of 0.1 by pharmacist professors from traditional medicine (this will dilute the mint essence in the base of the water). Cool water is used at a temperature of 15-7 ° C for washing the mouth and tongue, and menthol only will use for moisturizing the lips. The menthol is provided with preservatives will last an average of two months in the refrigerator. Intervention 2: The second intervention group (the plantagu ovata/ Esfarzah): The oral washing is done in a two-step process in the morning or evening shift. The prepared solution will last for up to 15 minutes by the researcher on the lips, tongue and oral mucosa of the patients. After 30 minutes, this intervention will be repeated again (The prepared solution will be used both for washing the mouth and tongue, and for wetting the lids). The plantagu ovata solution is sprayed at consentration of 0.2 grams (two tenths of gram) in 100 cc of water. The solution will have a preservative that will allow storage in the refrigerator for up to two months. It should be noted that the temperature of the solution is similar to cold water , and both (cold water and Esfarzeh Solution)will have the same temperature. For the preparation of Plantagu ovata, the powder of the outer part of the psyllium, which is available at the pharmacy (for the removal of constipation), will be used. Intervention 3: Control group: A group that only receives routine care. 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 There is not more information
public Elnaz Nasiri
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq.
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4325 eli1992nasiri@gmail.com Tehran University of Medical Sciences scientific leila Sayadi
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq.
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4322 l-sayadi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age over 18 years old At least 24 hours passed since their admission to the ICU Be able to understand Persian speak and have the ability to read Orientation to time، place and person Willingness to participate in study Do not received drugs such as opioids which suppress the consciousness Richmond criteria between -1 to +1. No history of allergies No history of allergy to the pessilium powder Thirst score more than 3 18 years no limit Both Having a open mouth lesions or lips lesions, mouth or lip mucous destroy History of dementia or Alzheimer، interaction of medical condition (like oral surgery) with study intervention Treatment - Other Treatment - Other N/A First intervention group (cold water with menthol): Oral washing (mouthwash/ oral care) with cold water and menthol is performed in a two-step process in the morning or evening shift. So that for a maximum of 15 minutes, cold water will be rubbed by the researcher to the lips, tongue and mucus Patients' mouths. and the lips of patients will also be moisturized using menthol. At least 30 minutes later, the washings will be repeated with cold water and menthol. Menthol is prepared with a percentage of 0.1 by pharmacist professors from traditional medicine (this will dilute the mint essence in the base of the water). Cool water is used at a temperature of 15-7 ° C for washing the mouth and tongue, and menthol only will use for moisturizing the lips. The menthol is provided with preservatives will last an average of two months in the refrigerator. The second intervention group (the plantagu ovata/ Esfarzah): The oral washing is done in a two-step process in the morning or evening shift. The prepared solution will last for up to 15 minutes by the researcher on the lips, tongue and oral mucosa of the patients. After 30 minutes, this intervention will be repeated again (The prepared solution will be used both for washing the mouth and tongue, and for wetting the lids). The plantagu ovata solution is sprayed at consentration of 0.2 grams (two tenths of gram) in 100 cc of water. The solution will have a preservative that will allow storage in the refrigerator for up to two months. It should be noted that the temperature of the solution is similar to cold water , and both (cold water and Esfarzeh Solution)will have the same temperature. For the preparation of Plantagu ovata, the powder of the outer part of the psyllium, which is available at the pharmacy (for the removal of constipation), will be used. Control group: A group that only receives routine care Thirst intensity: Those patients whose thirst scores are greater than three based on numeric rating scales. Timepoint: Before intervention, immediately after mouth washing for the first time, and also after second mouth washing (30 minutes after first one). Method of measurement: Numeric rating scales. Dry mouth : patient’s dryness feeling of lips and mouth. Timepoint: Before mouth washing, after mouth washing for the first time, and also after second mouth washing (30 minutes after first one). Method of measurement: Patient Self-declaration. Distress of Thirst: Feeling sick of thirst. Timepoint: Before intervention, after mouth washing for the first time, and also after second mouth washing (30 minutes after first one). Method of measurement: Numeric rating scales. Tehran University of Medical Sciences Approved 2018-09-04 Institutional research ethics committee school of nursing and midwifery & rehabilitation School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN Tehran Tehran Iran (Islamic Republic of)