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IRCT20181210041915N3 IRCT 2020-12-19 Ahvaz University of Medical Sciences Comparing the effectiveness of play therapy and storytelling on preoperative anxiety in preschool age children Comparing the effectiveness of play therapy, storytelling and routine protocol on preoperative anxiety in preschool age children(3-6 years) 2020-01-05 anticipated 102 Complete https://irct.ir/trial/48079 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In the current study, the children who were admitted to the hospital for a surgery and were representative of the inclusion criteria were selected using a simple random allocation strategy based on a table of random numbers. The procedure was as follows: a number was called from the table when a child patient was brought to the operating room. If the last digit of the randomly selected number was one of 1, 2 or 3, the candidate was assigned to the first intervention group (the storytelling group) and if the last digit of the number was one of 4, 5 or 6, the candidate had to enter the second intervention group (the play therapy group). Finally, if the last digit of the selected number was one of 7, 8 or 9, the nominated child was considered a control group participant (receiving routine treatments) and if the last digit was zero, another number had to be selected from the table. N/A Pre-surgery anxiety in children. Intervention 1: Intervention group one: The intervention in this group was Play Therapy. After random selection the child is assigned to this group and by entering the operation room, the child is assessed by the researcher. While the child is brought to the operation room on a stretcher or in a wheelchair, he/she is given the chance to pick toys based on his/her gender. For example, toys such as dolls and kitchen utensils or household objects were options for female participants, and a car, a cannon, a rifle, or a set of building blocks were available for the male participants to choose from and start playing. This intervention lasted for about 20 minutes under the supervision of the researcher. Intervention 2: Intervention group two: The method of the intervention in group two was storytelling. After random selection the child is assigned to this group, then he/she is assessed by the researcher. While the child is brought to the operation room on a stretcher or in a wheelchair, some story books such as “Hassani” are chosen based on the gender of the child from a series of short stories. These stories were visually appealing to the children because of varied and colorful images. The content was also relevantly chosen to include areas like, education, health, nutrition, discipline, and social regulation training. These books were read by the researcher, but in the presence of the parents. If the child did not like it, though, the parents were given the books to read them to the child, under the researcher's supervision; this intervention also lasted for 20 minutes. Intervention 3: Control Group: The Common Hospital Protocol was followed for the participants in this group. Midazolam was prescribed by the anesthesiologist, for the purpose of child’s sedation, and if the child’s anxiety was not relieved, thiopental sodium was used at sufficient doses to cause drowsiness and/or loss of consciousness. However, for the children who did not require sedation, only their parents or often a health care professional such as an anesthesiologist or an operating room specialist were permitted to accompany the child and stay. Yes - There is a plan to make this available What will be shared: Study data files can be provided if necessary When: Not yet published To whom: Academic institutions and universities Conditions: Researchers working in this field, if they obey full confidentiality and just use for scientific proposes purely. Where to obtain: By phone, fax or email and provide an official letter of introduction from the scientific institute How to obtain: First, he/she sends an official letter of introduction and a letter of request to access the data via email. When the letters were reviewed after a maximum of 20 days, he/she is given the access. Comments:
public Kourosh Zarea
Nursing and Midwifery School, Ahvaz Jundishapur university of medical sciences, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 6135864565 +98 61 3373 8071 zarea_k@ajums.ac.ir Ahvaz University of Medical Sciences scientific Kourosh Zarea
Nursing and Midwifery School, Ahvaz Jundishapur university of medical sciences, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 6135864565 +98 61 3373 8071 zarea_k@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Children of pre-school age Parental informed consent Mentally health No admitted to hospital or surgery in pervious 12 months No concomitant drug treatment 6 years 12 years Both Inability to communicate properly Behavior Behavior Behavior Intervention group one: The intervention in this group was Play Therapy. After random selection the child is assigned to this group and by entering the operation room, the child is assessed by the researcher. While the child is brought to the operation room on a stretcher or in a wheelchair, he/she is given the chance to pick toys based on his/her gender. For example, toys such as dolls and kitchen utensils or household objects were options for female participants, and a car, a cannon, a rifle, or a set of building blocks were available for the male participants to choose from and start playing. This intervention lasted for about 20 minutes under the supervision of the researcher. Intervention group two: The method of the intervention in group two was storytelling. After random selection the child is assigned to this group, then he/she is assessed by the researcher. While the child is brought to the operation room on a stretcher or in a wheelchair, some story books such as “Hassani” are chosen based on the gender of the child from a series of short stories. These stories were visually appealing to the children because of varied and colorful images. The content was also relevantly chosen to include areas like, education, health, nutrition, discipline, and social regulation training. These books were read by the researcher, but in the presence of the parents. If the child did not like it, though, the parents were given the books to read them to the child, under the researcher's supervision; this intervention also lasted for 20 minutes. Control Group: The Common Hospital Protocol was followed for the participants in this group. Midazolam was prescribed by the anesthesiologist, for the purpose of child’s sedation, and if the child’s anxiety was not relieved, thiopental sodium was used at sufficient doses to cause drowsiness and/or loss of consciousness. However, for the children who did not require sedation, only their parents or often a health care professional such as an anesthesiologist or an operating room specialist were permitted to accompany the child and stay. Preoperative anxiety in pre-school age children. Timepoint: Anxiety measurement was performed before the intervention and immediately after the intervention. Method of measurement: Observational Scale of Behavioral Distress-Revised (OSBD-R). Ahvaz University of Medical Sciences Approved 2019-05-25 ethical Committee of Ahvaz Jundishapur University of Medical Sciences Research Ethics Committee, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard Ahvaz Khouzestan Iran (Islamic Republic of)