İstanbul University - Cerrahpasa
Istanbul, Şişli, 34381, Turkey (Türkiye)
NCT Number: NCT06826352
Background:
It is important that reduce children's pain, fear, and anxiety during the invasive procedures for building effective communication with children and their parents. Knowing the effective methods will be helpful to use in the pediatric clinical.
Objective:
This study aimed to determine the effects of watching cartoons, a passive distraction method and playing video games, an active distraction method, on the pain, fear and anxiety of 3- to 7-year-old children before, during and after invasive procedures.
Design:
A randomized controlled clinical trial
Setting(s):
General pediatric service of a training and research hospital in Istanbul
Participants:
The study sample included 105 children who were 3- to 7-years-old inpatients. The children were randomly assigned to the control (n=35), cartoon (n=35) and video game (n=35) groups.
Methods:
The data were collected using an introductory information form, the Oucher Pain Scale, the Children's State Anxiety Scale, and the Children's Fear Scale between November 26, 2019 and January 8, 2020. Data analysis was performed with SPSS software using the chi-squared test, and one-way and repeated measures ANOVA.
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Notify Me3 year–7 year
All sexes
Interventional
Not applicable
Istanbul, Şişli, 34381, Turkey (Türkiye)
The randomized controlled experimental study involved 105 children hospitalized in the general pediatric service from November 26, 2019, to January 8, 2020. All participants met the inclusion criteria and provided voluntary consent, along with their parents. The children will randomly be assigned to control and experimental groups using sealed envelopes, ensuring an unbiased selection process. Each of the three groups comprised 35 children: one control group receiving routine nursing practices and two experimental groups receiving routine nursing practices supplemented by either a passive distraction method (watching cartoons) or an active distraction method (playing video games). Data collection utilized several instruments, including The Information Form, The Oucher Pain Scale, The Children's State Anxiety Scale, and The Children's Fear Scale.
Before the data collection process:
The study's objectives will be thoroughly explained to the children and their parents in with written consent obtained from participations' parents. Those who consented will be randomly assigned to with another nurse. The children in the cartoon group chose a cartoon, while those in the video game group select a video game
Data Collection Tools included:
Protocol:
There will be 3 groups. One of the groups will be a control group. The others are interventions group. One of intervention group is the passive distraction intervention which included watching cartoons. The other intervention group is the active distraction intervention which included playing video by mobile phone. During this method one of the nurses (not included the research) will be apply intravenous procedure.
Control Group: Children in the control group will be accompanied by a parent to the procedure room, where participants' vital signs will be recorded. Routine nursing practices, including bloodletting and intravenous procedure establishment, will be performed without any distraction methods. Pain, fear, and anxiety levels will be assessed by investigators two minutes before, during, and two minutes after the procedure.
Intervention Groups:
Passive Distractive Intervention Group Passive intervention group procedure is included cartoon watching. Children, in the Passive Distractive Intervention Group, will be accompanied by a parent to the procedure room, where participants' vital signs will be recorded. After that participations will be start watching cartoon, pain, fear, and anxiety levels will be measured at the same intervals as the control group, with observational recordings parameters made during the procedure. Parameters two minutes before, during, and two minutes after the procedure will be recorded by investigators to evaluate the overall impact of the distraction methods on pain, anxiety, and fear.
Cartoon Content: Prior to the procedure, children in the cartoon group select from a list of options, including Pepee, Niloya, Tom and Jerry, and Masha and The Bear. Cartoons time lapse is approximately 12 minutes. Participation begins to watch cartoon two minutes before the procedure and continued until its completion.
Active Distractive Intervention Group Children, in the Active Distractive Intervention Group, will be accompanied by a parent to the procedure room, where participants' vital signs will be recorded. Same procedure will be applied in this group. The participant will play the video with the hand he/she chooses to prevent the nurse's intravenous administration. Participants select the game, have no fixed time limits and continue until a play error occurred. Children can restart the game until the procedure concluded. Before the two minutes procedure the video will be started by participations and the parameters will be recorded two minutes before, during, and two minutes after the procedure by investigators Video Game Content: Children in the video game group were recommended games playable with one hand, such as Red Ball, Subway Surfers, Candy Crush Saga, and Wood Block Puzzle.
Children's pain, fear, and anxiety levels will be assessed using the Oucher Pain Scale, the Children's State Anxiety Scale, and the Children's Fear Scale before, during, and after the procedure. Vital signs, including pulse and oxygen saturation, will be measured using pulse oximetry, while blood pressure was assessed with a sphygmomanometer and stethoscope.
Study Hypotheses:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The video games will be played by children during the procedure.
The cartoons will be selected by the children related to their interests. The cartoons are included Pepee, Niloya, Tom and Jerry, Masha and The Bear and others.
Time frame: Pain score will be decrease during the procedure within the 3 minutues.
Zero is equivalent to no pain and 10 indicates the worst possible pain.
Time frame: State Anxiety level will be decrease during the procedure within the 3 minutues.
Zero is equivalent to no anxiety and 10 indicates the highest possible anxiety.
Time frame: The fear will be decrease during the procedure within the 3 minutues.
It has five facial expressions: a face with no expressions (0=no anxiety) to a face showing fear (4=severe anxiety).
Istanbul University - Cerrahpasa
Other
The Effects of Active and Passive Distraction Methods on Children's Pain, Fear and Anxiety During Invasive Procedures: a Randomized Controlled Clinical Trial
Acronym: RCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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