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IRCT20230409057861N1 IRCT 2023-11-08 Khoram-Abad University of Medical Sciences Comparison of rosa and peppermint scents on postoperative pain and anxiety in children with abdominal surgery Comparison of rosa and peppermint scents on postoperative pain and anxiety in 6-12 years children with abdominal surgery 2024-03-05 anticipated 36 Complete https://irct.ir/trial/69487 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Allocation of samples in groups is done using random block method. In order to equalize the distribution of gender confounding variables and the level of anxiety before the intervention, first classes based on these variables as described by girl/boy and mild (≥17)/moderate (18-24)/severe (25-30)/very severe anxiety (<30) are created and then they are balanced in the studied groups by random block method, Blinding description: This study is one-sided blind and the statistical consultant is blind. After collecting the data without identifying the intervention and control groups, descriptive statistics are used to describe the data, calculating central and dispersion indices for quantitative variables and frequency and percentage for qualitative variables. 2-3 Abdominal surgery. Intervention group: In the intervention groups, 2 drops of rose essential oil or peppermint will be poured on a pad soaked in normal saline and will be attached to the collar of the child's clothes for half an hour. Immediately after removing the pad, the child's pain and anxiety will be measured. In the control group, A pad soaked in unscented normal saline will be used. The anxiety of the units studied by the researcher and assistant researchers one hour after the child's hospitalization before receiving the scent and 8 hours after hospitalization, 9, 12 and 16 hours after the operation and receiving the scent half an hour before the above hours with the Hamilton tool through an interview with the mother by the researchers will be measured. Also, children's pain will be measured using Flak tool upon entering from the operating room to the ward before giving the aroma at half, three, six, nine, twelve and sixteen hours after the operation and receiving the aroma for half an hour by the researcher and assistant researchers.. No - There is not a plan to make this available Justification or reason for not sharing IPD is The result was unclear due to the reason
public Zahra nadri
Emam khomeyni
Aleshtar Iran (Islamic Republic of) 6895113435 0098 58282618 Z.nadri77@gmail.com Khoram-Abad University of Medical Sciences scientific Zahra Nadri
Golshan Alley 7, Yadgar Imam Square, Imam Khomeini Ave
Aleshtar Iran (Islamic Republic of) 6895113435 0098 58282618 Z.nadri7@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Having both parents Children should be 6 to 12 years old The child should be awake before the surgery Always accompany the child and only the mother Verbal consent of the child to participate in the stud Ability of child and mother to communicate verbally Performing elective abdominal surgery in children Presence of the child and mother at least 12 hours before and 18 hours after the operation in the ward 6 years 12 years Both Prolonging surgery in the operating room Having complications during surgery and complications of anesthesia (severe hypothermia) The occurrence of unwanted complications after surgery such as bleeding, opening of the surgical site, etc. Need for ICU after surgery Child's and mother's unwillingness to continue the research Moving the child to another department/hospital Discharge of children from the hospital with personal consent the impossibility of the parent being with the child during the entire period of hospitalization for any reason (illness, personal problems, etc Disruption in completing the anxiety questionnaire by the mother Occurrence of symptoms of allergy to scents in the child or mother during the study Patients with acute problems and undergoing emergency surgeries The child has multiple surgical incisions Performing major abdominal surgeries (volvulus, laparotomy obstruction) and multiple incisions History of surgery or hospitalization in the child Physical and metabolic diseases such as diabetes and phenylketonuria in children History of allergic rhinitis in child and mother History of respiratory, skin and dermatitis sensitivity in child and mother The presence of chronic pain in children Taking painkillers or sedatives during 24 hours before abdominal surgery by the child Taking nerve medication or suffering from nerve diseases such as anxiety and depression, hyperactivity and autism Use of hypnotics, sedatives or benzodiazepines by the child within a week before the start of the intervention. Use of systemic painkillers such as ibuprofen and acetaminophen before surgery in children Use of complementary medicine methods (aromatherapy, etc.) for the child and parents for a week before the intervention. A child suffering from mental retardation Obvious cognitive, psychological or physical problems in parents and children Z40.8 Encounter for other prophylactic surgery Placebo Intervention group: In the intervention groups, 2 drops of rose essential oil or peppermint will be poured on a pad soaked in normal saline and will be attached to the collar of the child's clothes for half an hour. Immediately after removing the pad, the child's pain and anxiety will be measured. In the control group, A pad soaked in unscented normal saline will be used. The anxiety of the units studied by the researcher and assistant researchers one hour after the child's hospitalization before receiving the scent and 8 hours after hospitalization, 9, 12 and 16 hours after the operation and receiving the scent half an hour before the above hours with the Hamilton tool through an interview with the mother by the researchers will be measured. Also, children's pain will be measured using Flak tool upon entering from the operating room to the ward before giving the aroma at half, three, six, nine, twelve and sixteen hours after the operation and receiving the aroma for half an hour by the researcher and assistant researchers. Percentage of children candidates for abdominal surgery. Timepoint: Hospitalization time in the ward and before aromatherapy, immediately after the operation and at half an hour, 3, 6, 9, 12 and 16 hours after the operation. Method of measurement: Data collection tools in this research include the demographic information collection form, FLACC pain behavioral reaction checklist, and Hamilton's anxiety questionnaire. Blood oxygen saturation percentage. Timepoint: at the time of entering the ward and before aromatherapy, and at half, 3, 6, 9, 12 and 16 hours after the operation. Method of measurement: Pulse oximetry device. Khoram-Abad University of Medical Sciences Approved 2023-02-04 Ethics Committee of Lorestan University of Medical Sciences Moalem ave Khoram Abad Lorestan Iran (Islamic Republic of)