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IRCT20111207008315N30 IRCT 2020-07-13 Tabriz University of Medical Sciences The effect of aromatherapy on hernia operation pain Comparison the Effect of Lavender and Geranium (Pelargonium Graveolens) on Pain after Hernia Repair Surgery of Hospitalized Children under 1 Year: a Randomized Clinical Trial 2019-06-22 anticipated 60 Complete https://irct.ir/trial/48932 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects were recruited using the convenient method and then for randomization, sealed envelopes containing one of the letters A, B, C (a total of 60: 20 of each letter) were used, which were selected by the companion and according to the contents of the envelope indicated which group it belonged to, Blinding description: Participants and experiment doer ,evaluators were unaware of the contents of the essential oils. N/A Comparison the effect of lavender and geranium essential oil. Intervention 1: Intervention group; Lavender: When children enter the ward from the operating room, first their group is determined by the closed envelope method and immediately their pain is measured with FLACC pain tool by the researcher herself and then according to the ward routine section of acetaminophen as a painkiller. Once again after the analgesic (Acetaminophen/Apotel) injection as ward routine, the patient's pain is measured and recorded. Then, at intervals of 1, 3, 6, 9 and 12 hours after the operation, lavender essential oil is inhaled five times and the pain is measured thirty minutes since inhalation starts or 20 minutes after ending the each aromatherapy. The packages (5 dark glasses) are prepared and coded under the supervision of a pharmacologist and by another person, and the researcher conducting the intervention does not know the nature of the essential oil in the containers. The container be placed in front of the patient's nose for 10 minutes at a distance of 10 cm. The data is analyzed in SPSS software. Intervention 2: Intervention group, geranium rose: When children enter the ward from the operating room, first their group is determined by the closed envelope method and immediately their pain is measured with FLACC pain tool by the researcher herself and then according to the ward routine section of acetaminophen as a painkiller. Once again after the analgesic (Acetaminophen/Apotel) injection as ward routine, the patient's pain is measured and recorded. Then, at intervals of 1, 3, 6, 9 and 12 hours after the operation, Geranium Rose essential oil is inhaled five times and the pain is measured thirty minutes since inhalation starts or 20 minutes after ending the each aromatherapy. The packages (5 dark glasses) are prepared and coded under the supervision of a pharmacologist and by another person, and the researcher conducting the intervention does not know the nature of the essential oil in the containers. The container be placed in front of the patient's nose for 10 minutes at a distance of 10 cm. The data is analyzed in SPSS software. Intervention 3: Control group, sweet almond placebo: When children enter the ward from the operating room, first their group is determined by the closed envelope method and immediately their pain is measured with FLACC pain tool by the researcher herself and then according to the ward routine section of acetaminophen as a painkiller. Once again after the analgesic (Acetaminophen/Apotel) injection as ward routine, the patient's pain is measured and recorded. Then, at intervals of 1, 3, 6, 9 and 12 hours after the operation, sweet almond oil is inhaled five times and the pain is measured thirty minutes since inhalation starts or 20 minutes after ending the each aromatherapy. The packages (5 dark glasses) are prepared and coded under the supervision of a pharmacologist and by another person, and the researcher conducting the intervention does not know the nature of the essential oil in the containers. The container be placed in front of the patient's nose for 10 minutes at a distance of 10 cm. The data is analyzed in SPSS software. No - There is not a plan to make this available Justification or reason for not sharing IPD is -
public Leila Valizadeh
Shariati St. School of Nursing and Midwifery
Tabriz Iran (Islamic Republic of) 51389477977 +98 41 3479 6770 valizadehl@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Leila Valizadeh
School of Nursing and Midwifery, Shariati street.
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 valizadehl@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Children hospitalized in the pediatric surgery department. Candidates for surgery are both male and female Family satisfaction with their children's participation in the study No respiratory problems such as asthma and allergic rhinitis Having a companion in the children participating in the study Children under one year old 2 months 1 year Both Lack of cooperation between the patient and the patient's family during the intervention The patient's death Patient discharge before the intervention Homeless and unaccompanied child Sensitivity to the smell of lavender, geranium and sweet almond The use of perfume and other fragrances by the child or with the child Multiple surgeries Children under 2 months Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group; Lavender: When children enter the ward from the operating room, first their group is determined by the closed envelope method and immediately their pain is measured with FLACC pain tool by the researcher herself and then according to the ward routine section of acetaminophen as a painkiller. Once again after the analgesic (Acetaminophen/Apotel) injection as ward routine, the patient's pain is measured and recorded. Then, at intervals of 1, 3, 6, 9 and 12 hours after the operation, lavender essential oil is inhaled five times and the pain is measured thirty minutes since inhalation starts or 20 minutes after ending the each aromatherapy. The packages (5 dark glasses) are prepared and coded under the supervision of a pharmacologist and by another person, and the researcher conducting the intervention does not know the nature of the essential oil in the containers. The container be placed in front of the patient's nose for 10 minutes at a distance of 10 cm. The data is analyzed in SPSS software. Intervention group, geranium rose: When children enter the ward from the operating room, first their group is determined by the closed envelope method and immediately their pain is measured with FLACC pain tool by the researcher herself and then according to the ward routine section of acetaminophen as a painkiller. Once again after the analgesic (Acetaminophen/Apotel) injection as ward routine, the patient's pain is measured and recorded. Then, at intervals of 1, 3, 6, 9 and 12 hours after the operation, Geranium Rose essential oil is inhaled five times and the pain is measured thirty minutes since inhalation starts or 20 minutes after ending the each aromatherapy. The packages (5 dark glasses) are prepared and coded under the supervision of a pharmacologist and by another person, and the researcher conducting the intervention does not know the nature of the essential oil in the containers. The container be placed in front of the patient's nose for 10 minutes at a distance of 10 cm. The data is analyzed in SPSS software. Control group, sweet almond placebo: When children enter the ward from the operating room, first their group is determined by the closed envelope method and immediately their pain is measured with FLACC pain tool by the researcher herself and then according to the ward routine section of acetaminophen as a painkiller. Once again after the analgesic (Acetaminophen/Apotel) injection as ward routine, the patient's pain is measured and recorded. Then, at intervals of 1, 3, 6, 9 and 12 hours after the operation, sweet almond oil is inhaled five times and the pain is measured thirty minutes since inhalation starts or 20 minutes after ending the each aromatherapy. The packages (5 dark glasses) are prepared and coded under the supervision of a pharmacologist and by another person, and the researcher conducting the intervention does not know the nature of the essential oil in the containers. The container be placed in front of the patient's nose for 10 minutes at a distance of 10 cm. The data is analyzed in SPSS software. Pain score. Timepoint: 0, half hour after surgery without aromatherapy, and in 1,3,6,9,12 hours after surgery with aromatherapy. Method of measurement: FLACC pain rating scale. Tabriz University of Medical Sciences Approved 2018-09-10 Tabriz University of Medical Sciences ethic committee Ethic committee, Research deputy building,Tabriz University of Medical Sciences, Golgasht Street, Azadi Street,Tabriz, East Azerbaijan, Iran., Tabriz East Azarbaijan Iran (Islamic Republic of)