Clinical trial NCT06593002: The Effect of Therapeutic Play on Children's Pain and Fear and Parents and Students' Satisfaction Levels
Official title: The Effect of Pre-Treatment Therapeutic Play With Nursing Students on Children's Pain and Fear and on the Satisfaction Levels of Parents and Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior
Pain
Anxiety
Anxiety and Fear
Keywords: Pain
Anxiety
Children
Nursing Student
therapeutic play
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 64
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: The universe of the study consisted of hospitalized children aged 3-6, their primary caregivers, and 3rd year nursing students taking the Pediatric Nursing course.

Children and Parents: G\*Power 3.1.9.6. program was used to calculate the sample size of the study. According to the a priori power analysis of the study with one-way hypothesis, 0.634 effect size, 0.05 significance level, and 0.80 power; it was determined that including a total of 64 (Experiment: 32 children + parents, Control: 32 children + parents) children in the study would provide a sufficient sample size.

Nursing students: No sample calculation method was used, and all students who wanted to make therapeutic toys and play games with their patients were included in the study. 141 students who wanted to participate in the study out of a total of 178 students taking the course were included in the study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to determine the effects of playing with therapeutic toys made by nursing students on children's fear and pain levels towards treatment and the satisfaction levels of student nurses and parents.

Detailed description: There are a limited number of studies in the literature examining the effects of therapeutic play implemented by nursing students. Although there are many studies showing that therapeutic play intervention is an effective intervention for sick children, it is seen that these studies are mostly conducted by researchers or clinical staff, and nursing students who have been in pediatric wards for a long time due to their clinical practices are far from therapeutic play practices. Therapeutic play may be a way for nursing students to initiate communication with children more easily. Therefore, there is a need for large-scale studies including nursing students. Starting from their student years, nursing students using therapeutic play as a means of communication with sick children may make them more willing to use such activities in their professional lives. In addition, determining the satisfaction levels is important for the continuation of such studies in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Having a child aged 3-6
* Having at least two days of inpatient treatment in the hospital (to gain experience with medication administration)
* Being accompanied by a parent
* Having one invasive drug treatment ordered by a doctor - Knowing and speaking Turkish
* Being willing to participate in the study

Exclusion Criteria:

* Those who are in intensive care,
* Those who have undergone surgery,
* Those who do not have a companion with their mother,
* Children with neurological and psychological disorders and parents,
* Children who only receive oral medication (as the level of pain and fear related to treatment will be low)

Primary outcomes:
measure: Child and Parent Information Form
timeFrame: First measurement: 30 minute before treatment
measure: Wong-Baker Pain Scale
timeFrame: First measurement: Just before treatment
measure: Child Fear Scale
timeFrame: First measurement: Just before treatment
Secondary outcomes:
measure: Wong-Baker Pain Scale
timeFrame: Second measurement: within five minutes after the treatment is completedAfter treatment
measure: Child Fear Scale
timeFrame: Second measurement: within five minutes after the treatment is completed
measure: Student Satisfaction Survey
timeFrame: Within five minutes after the treatment is completed
measure: Parent Satisfaction Survey
timeFrame: Within five minutes after the treatment is completed
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
affiliation: Selcuk University
name: Sibel Küçükoğlu
role: STUDY_DIRECTOR
References:
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.
citation: Gates M, Hartling L, Shulhan-Kilroy J, MacGregor T, Guitard S, Wingert A, Featherstone R, Vandermeer B, Poonai N, Kircher J, Perry S, Graham TAD, Scott SD, Ali S. Digital Technology Distraction for Acute Pain in Children: A Meta-analysis. Pediatrics. 2020 Feb;145(2):e20191139. doi: 10.1542/peds.2019-1139. Epub 2020 Jan 22.
citation: Li WHC, Chung JOK, Ho KY, Kwok BMC. Play interventions to reduce anxiety and negative emotions in hospitalized children. BMC Pediatr. 2016 Mar 11;16:36. doi: 10.1186/s12887-016-0570-5.