Comparison of the effect of two distraction methods, puppet play and distraction cards, on preoperative anxiety and postoperative pain under tonsillectomy surgery in children (3-6 years old).
Determining the effect of puppet play and distraction cards on preoperative anxiety and postoperative pain under tonsillectomy surgery in children aged 3-6 years.
Design
Clinical trial with control group, with parallel groups, randomized, on 81 patients
Settings and conduct
In this study, young children (3-6 years old) undergoing tonsillectomy surgery referred to Imam Sajjad Hospital in Yasouj will participate. The researched samples will be selected according to the convenience Sampling method and will be randomly assigned to one of the three study groups (two intervention groups and one control group).
Participants/Inclusion and exclusion criteria
undergoing non-emergency tonsillectomy surgery; Age range 3-6 years
; Obtaining informed consent from parents
Intervention groups
Eligible sample are divided into three groups of puppet play intervention (27 people), distraction cards intervention (27 people) and control group (27 people) based on the inclusion and exclusion criteria. The intervention groups will be subjected to a finger puppet show or intervention by distraction cards accompanied by the presenter for 20 minutes each, based on the intervention group. After the intervention, the anxiety of the research samples will be measured again with the Yale preoperative anxiety scale. Also, in order to evaluate the effectiveness of the intervention on postoperative pain, it will be measured with the FLACC children's pain assessment scale at 6 hours and 12 hours after surgery.
Main outcome variables
preoperative anxiety; postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240424061558N2
Registration date:2024-06-27, 1403/04/07
Registration timing:registered_while_recruiting
Last update:2024-06-27, 1403/04/07
Update count:0
Registration date
2024-06-27, 1403/04/07
Registrant information
Name
Hesamoddin Khalesro
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3311 3022
Email address
hesamkhro@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two distraction methods, puppet play and distraction cards, on preoperative anxiety and postoperative pain under tonsillectomy surgery in children (3-6 years old).
Public title
Comparation of two methods of distraction on anxiety and pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
non-emergency tonsillectomy surgery
Age range 3-6 years
Obtain informed consent from parents
Exclusion criteria:
Having a history of surgery and hospitalization
The existence of mental and psychological disorders in the child
Having underlying physical diseases
Family members with clinically diagnosed mental illness or disorder
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected byConvenience Sampling method and will be allocated to one of the three study groups (two intervention groups and one control group) in the form of block randomization allocation.
In this way, participants will be divided into three groups (two intervention groups and one control group). First, by multiplying the number of groups under study (three groups) by 2, the number of samples per block is calculated to be 6. Then, by calculating the factorial, the number of samples per block (720 = 1×2×3×4×5×6 = 6!) is determined, resulting in 720 blocks from all possible arrangements of individuals. Since the number of individuals in each block is 6, each block will contain 6 participants (2 participants from each group) with different arrangements. Therefore, the blocks will be randomly selected with replacement, ensuring that each selected block contains 6 participants, with their allocation already determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Yasuj University of Medical Sciences
Street address
Shahid Motahhari Blvd., Headquarters of Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2024-05-29, 1403/03/09
Ethics committee reference number
IR.YUMS.REC.1403.026
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score in modified Yale preoperative anxiety scale
Timepoint
The beginning of the study(before the intervention), after the study
Method of measurement
modified Yale Preoperative Anxiety Scale (mYPAS)
2
Description
Pain score in FLACC pediatric pain assessment scale