Clinical trial NCT06415188: The Effect of Therapeutic Play on Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction
Official title: The Effect of Therapeutic Play on Pre-Treatment Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior
Pain, Acute
Anxiety and Fear
Keywords: Pain
anxiety
children
nursing
therapeutic play
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was conducted on children aged 3-6 years. The study was completed with a total of 40 children and parent pairs in the experimental and control groups. Simple randomization method was used in the study. The randomization table for which group the children would be in was made by an independent statistician. Letters A and B were used to represent the experimental and control groups. Which letter represented which group was determined by lottery. While therapeutic play intervention was applied in the experimental group, routine intervention was applied in the control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the effect of the therapeutic game applied before treatment on pain, fear, anxiety and physiological parameters and the satisfaction of the parents was investigated.

Detailed description: Therapeutic play is defined as activities structured in accordance with children's age and development, or as a set of interventions to improve the well-being of children in the hospital environment. This method reduces the stress of illness or hospitalization, uses play as a means of self-expression and supports the development of positive coping mechanisms in pediatric patients. In the literature, it is seen that therapeutic play methods such as listening to music, drawing, reading stories, puppets, dolls, virtual reality tools, cartoon applications, watching videos and playing video games are used to reduce the child's pain and anxiety about invasive procedures. Studies conducted to reduce the interactions between children in the same environment during their treatment and care are quite limited. No study has been found to examine the effect of methods that jointly block/reduce vision and hearing during treatment and care on anxiety, fear and pain in children treated together in pediatric clinics.

Eligibility criteria: For the Child;

Inclusion Criteria:

* Being in the 3-6 age group,
* At least one day of inpatient treatment in the pediatric clinics of Selçuk Medical Faculty Hospital
* At least one invasive intervention in the treatment plan
* To be able to understand and speak Turkish
* Staying in a room with at least two beds

Exclusion Criteria:

* Having a neurological disorder
* Not having a parent as a companion
* Receiving oral treatment only
* Hearing and vision problems
* Single bed capacity room or isolated room

For the Parent

Inclusion Criteria:

* Staying with their child as a constant companion
* To be able to understand and speak Turkish
* Accepting to participate in the study

The exclusion criteria:

* Not staying with your child all the time

Primary outcomes:
measure: Descriptive Characteristics Information Form
timeFrame: First measurement: 30 minute before treatment
measure: Physiological Parameter Monitoring Form
timeFrame: First measurement: 1 minute before treatment
measure: Children's State Anxiety and Children's Fear Scale
timeFrame: First measurement: 1 minute before treatment
measure: Visual Analog Scale
timeFrame: First measurement: 1 minute before treatment
measure: PedsQL Health Care Satisfaction Scale
timeFrame: First measurement: After treatment
Secondary outcomes:
measure: Physiological Parameter Monitoring Form
timeFrame: Second measurement: 1 minute after treatment
measure: Children's State Anxiety and Children's Fear Scale
timeFrame: Second measurement: 1 minute after treatment
measure: Visual Analog Scale
timeFrame: Second measurement: 1 minute after treatment
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
affiliation: Selcuk University
name: Sibel Kucukoglu, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.
citation: Silva SGTD, Santos MA, Floriano CMF, Damiao EBC, Campos FV, Rossato LM. Influence of Therapeutic Play on the anxiety of hospitalized school-age children: Clinical trial. Rev Bras Enferm. 2017 Nov-Dec;70(6):1244-1249. doi: 10.1590/0034-7167-2016-0353. English, Portuguese.
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citation: Inan G, Inal S. The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial. Clin J Pain. 2019 Feb;35(2):140-147. doi: 10.1097/AJP.0000000000000666.
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citation: Burns-Nader S, Joe L, Pinion K. Computer tablet distraction reduces pain and anxiety in pediatric burn patients undergoing hydrotherapy: A randomized trial. Burns. 2017 Sep;43(6):1203-1211. doi: 10.1016/j.burns.2017.02.015. Epub 2017 Mar 18.