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IRCT20130803014251N10 IRCT 2024-01-28 Abadan University of Medical Sciences Comparing the effects of painting therapy and aromatherapy with Rosa damascena Mill. on the management of anxiety, pain, and complications of tonsillectomy Comparing the effects of painting therapy, aromatherapy with Rosa damascena Mill., and aromatherapy with placebo on the management of anxiety, pain, and complications of tonsillectomy among children aged 6-12 years 2024-01-19 anticipated 84 Complete https://irct.ir/trial/72667 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, each admitted participant will be allocated a number from 1-84. Then, participants will be stratified by age using the stratified method. Subsequently, participants of each stratify will be equally assigned to painting therapy, aromatherapy with Rosa Damascena Mill., and aromatherapy with placebo groups, utilizing the Stat Trek software with a random number generator. Randomization will be accomplished by a researcher assistant, who will be unaware of the aim of this trial and will be the only individual with access to group allocations. 3 Condition 1: Anxiety. Condition 2: Surgical complications. Condition 3: Acute tonsillitis. Condition 4: Pain. Intervention 1: First Intervention group: The participants in the first experimental group will receive surgical preparation and perioperative care based on the standard protocols of the recruitment hospitals. Additionally, they will receive a painting therapy program in two 20-minute sessions in the hospital and three 20-minute sessions after hospital discharge. Intervention 2: Second Intervention group: The participants in the first experimental group will receive surgical preparation and perioperative care based on the standard protocols of the recruitment hospitals. Additionally, they will receive an inhalation aromatherapy with two drops of Rosa damascena Mill. essence in two 20-minute sessions in the hospital and three 20-minute sessions after hospital discharge. Intervention 3: Control group: The participants in the control group will receive surgical preparation and perioperative care based on the standard protocols of the recruitment hospitals. Additionally, they will receive an inhalation aromatherapy with two drops of placebo (distilled water) in two 20-minute sessions in the hospital and three 20-minute sessions after hospital discharge. Yes - There is a plan to make this available What will be shared: Only a part of patients' demographical data and main outcomes will be shared. When: After the publishing of the results To whom: Data will be available only for researchers working on academic and university associations. Conditions: Mention of study details and authors name Where to obtain: Morteza Nasiri: Department of Operating Room, School of Allied Medical Sciences, Tehran University of Medical Sciences, Tehran, Iran How to obtain: Information will provide via the following email upon request. Mortezanasiri.or87@yahoo.com Comments:
public Masoomeh Asadi
Building of Abadan University of Medical Sciences, Zulfaqari, 30M street, Abadan, Khuzestan province, Iran
Abadan Iran (Islamic Republic of) 6319811154 +98 61 5338 4004 M.asadi@abadanums.ac.ir Abadan University of Medical Sciences scientific Morteza Nasiri
No.17, Fardanesh Alley, Qods Street, Enqelab Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 44361-14177 +98 21 8898 2905 mnasiri@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Desiring to participate in the research and complete the written consent form Being 6-12 years old Admitting to the hospital the night before the surgery Undergoing tonsillectomy under general anesthesia and by dissection and snare approach Having class I and II of the American Society of Anesthesiology (ASA) Accessing to a smartphone to participate in follow-up sessions after hospital discharge 6 years 12 years Both A history of sensitivity to scents and perfumes Having a disorder in the sense of smell Presence of cognitive or mental disorders, heart diseases, and chronic pain based on medical records Participation in previous courses of painting therapy or aromatherapy A history of surgery and anesthesia A history of tonsillectomy for another child in the family F06.4 Y83.9 J03.9 R07.0 Anxiety disorder due to known physiological condition Surgical procedure, unspecified as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Acute tonsillitis, unspecified Pain in throat Treatment - Other Treatment - Other Placebo First Intervention group: The participants in the first experimental group will receive surgical preparation and perioperative care based on the standard protocols of the recruitment hospitals. Additionally, they will receive a painting therapy program in two 20-minute sessions in the hospital and three 20-minute sessions after hospital discharge. Second Intervention group: The participants in the first experimental group will receive surgical preparation and perioperative care based on the standard protocols of the recruitment hospitals. Additionally, they will receive an inhalation aromatherapy with two drops of Rosa damascena Mill. essence in two 20-minute sessions in the hospital and three 20-minute sessions after hospital discharge. Control group: The participants in the control group will receive surgical preparation and perioperative care based on the standard protocols of the recruitment hospitals. Additionally, they will receive an inhalation aromatherapy with two drops of placebo (distilled water) in two 20-minute sessions in the hospital and three 20-minute sessions after hospital discharge. Tonsillectomy-induced anxiety. Timepoint: 4 steps: 1) the night before surgery in the hospitalized ward: before the start of the first intervention session as the first pre-test, 2) the day of surgery immediately before transferring the samples from the hospitalized ward to the operating room department: as the first post-test, 3) The day of surgery at the beginning of admitting the samples in the waiting room before surgery: before the start of the second intervention session as the second pre-test, 4) the day of surgery when lying on the surgery bed and immediately before induction of anesthesia: as the second post-test. Method of measurement: Modified Yale preoperative anxiety scale. Pain. Timepoint: The first three days after discharge from the hospital. Method of measurement: Numerical pain rating scale (or Wong-Baker faces pain rating scale). Complications of tonsillectomy. Timepoint: The first three days after discharge from the hospital. Method of measurement: Researcher-made checklist. Abadan University of Medical Sciences Approved 2023-08-05 Ethics Committee of Abadan University of Medical Sciences Building of Abadan University of Medical Sciences, Zulfaqari, 30M street, Abadan, Khuzestan province, Iran Abadan Khouzestan Iran (Islamic Republic of)