]>
IRCT20181117041683N1 IRCT 2019-02-05 Kermanshah University of Medical Sciences Effect of painting therapy and midazolam on anxiety A comparative Study of the effect of painting therapy and drug therapy on the anxiety of children undergoing tonsillectomy 2019-01-21 anticipated 90 Complete https://irct.ir/trial/35308 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Similar studies have been conducted on several surgeries, but none have studied just one particular surgery. Since the type of surgery affects the amount of anxiety, we have studied only the tonsillectomy surgery, which is the second most commonly used surgical procedure in children.Recent studies have also compared some supportive interventions with midazolam, but none of these studies have compared painting therapy alone with midazolam, Randomization description: Initial sampling will be available in a non-randomized way.Then, the samples in this study will be assigned by random allocation of patients in the study groups (control, medication intervention and artistic intervention). Samples will be assigned to three groups by random sampling block Permutation. In this way, the study will continue until the number of samples has been completed. To implement this randomization method, the following will be done: 1. The total sample size and sample size ratio will be specified in the groups. 2. Single digit numbers between 0 and 9 will be selected from random numbers table. 3.For studies with 3 groups, numbers 0-9 will be divided into 3 equal blocks, wich the probability of allocating one to each block will be 0.5. Block 1-3 will be used for the first group and block 4-6 for the second group and block 7-9 for the third group.It will be determined by numbers selected from random numbers table and blocks determination that anyone who has entered the study will be placed in which group. 3 Condition 1: Anxiety. Condition 2: Tonsilectomy. Intervention 1: Intervention group: Drug therapy - Midazolam hydrochloride - 0/020mg / kg - Single intravenous injection - Pharmaceutical chemistry. Intervention 2: Intervention group: Painting Therapy with Stedler color pencil and marker made in Germany. Asking children to paint about what they imagine about operating room and also providing colorless pictures and caricatures (about operating room and surgical team) to be colored by children. Intervention 3: Control group: Routin 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 No more information.
public Samane Babaei
Isar Square, Dolatabad Blvd, Paramedical School, Operative Group
Kermanshah Iran (Islamic Republic of) 6719851351 +98 83 3826 2042 S.babaei7203@yahoo.com Kermanshah University of Medical Sciences scientific Samane Babaei
Isar Square, Dolatabad Blvd, Paramedical School, Operative Group
Kermanshah Iran (Islamic Republic of) 6719851351 +98 83 3826 2042 S.babaei7203@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Admission of patient at the night before surgery Children between 5 and 12 years Type of surgery: Tonsillectomy Consent of parents 5 years 12 years Both Physiological and psychological disease Surgery history Anesthesia history Consumption of special drugs Dissatisfaction of parents Treatment - Drugs Treatment - Devices Other Intervention group: Drug therapy - Midazolam hydrochloride - 0/020mg / kg - Single intravenous injection - Pharmaceutical chemistry Intervention group: Painting Therapy with Stedler color pencil and marker made in Germany. Asking children to paint about what they imagine about operating room and also providing colorless pictures and caricatures (about operating room and surgical team) to be colored by children. Control group: Routin care Preoperative anxiety score in anxiety scale. Timepoint: 1. Before intervention in the waiting room. 2. After intervention and in the operating room at induction of anesthesia. Method of measurement: 1-State and Trait Anxiety Inventory scale 2-Visual Analoguous Scale 3-modified Yale Preoperative Anxiety Scale. Kermanshah University of Medical Sciences Approved 2018-12-05 Ethics Committee of Kermanshah University of Medical Sciences Dolatabad, School of Kermanshah Paramedicine Kermanshah Kermanshah Iran (Islamic Republic of)