Clinical trial NCT06262984: Therapeutic Play Before Nasopharyngeal Swabbing in Children
Official title: The Effect of the Therapeutic Play Applied Before Nasopharyngeal Swaping on Children's Emotional Manifestation in the 3-6 Years Old Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Coping
Keywords: Child
Nasopharyngeal swab
Therapeutic play
Emotional manifestation
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 68
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will be conducted with the randomized controlled experimental method. Children who apply to the Child Health and Diseases Polyclinic and Child Health and Diseases Service and who will have nasopharyngeal swab applied will be divided into two groups by drawing lots. After the randomization children in the therapeutic play group the nasal swab will be shown on the doll to the child by the researcher before being taken. The child is then allowed to play with the doll accompanied by the researcher. No intervention will be performed on children in the control group. The parents will also be found next to their children in both groups during the procedure.

Detailed description: Many different non-pharmacological methods are used to cope with negative emotional responses such as pain, stress, fear and anxiety caused by diagnostic procedures in children. One of these non-pharmacological methods is therapeutic play. Therapeutic play method applied in line with the philosophy of atraumatic care in preparation for medical diagnostic procedures can ensure children's adaptation to the procedures by reducing the negative emotional effects of these procedures on the child. Energy Expenditure Play, Dramatic Play and Creative Play are used as therapeutic play types.

The aim of this study is to determine the effect of therapeutic play applied before the nasopharyngeal swab procedure on the emotional indicators of children aged 3-6 years who apply to the pediatric clinic and pediatric service. In line with the results obtained from studies using a similar research method, the sample size of the study was determined by power analysis (G\*Power 3.1.9.4). The sample size was found to be 68 children in total, with a minimum of 34 children for each group. To collect data, an information form and the Children's Emotional Manifestation Scale (CEMS) will be used. Children and their parents who apply to the pediatric service and pediatric outpatient clinic will be informed about the study. The children and parents included in the study will be informed about the research by the researcher through a face-to-face meeting, and a consent form and information form will be filled out. Children will determine their groups by drawing lots. The researcher will demonstrate the nasopharyngeal swabbing process on the doll with the children who have chosen a therapeutic play group, using a therapeutic play method, and play with the child. Children who choose the control group will be explained the nasopharyngeal swab procedure as routinely performed in the outpatient clinic. The Children's Emotional Manifestation Scale (CEMS) will be evaluated and scored by the researcher and the observing nurse.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 3 and 6,
* Children who have not received medical attention in the last 24 hours,
* Children without speech, hearing, psychological or neurological problems,
* Children who can speak and understand Turkish at native level,
* Children and their parents who agree to participate in the research.

Exclusion Criteria:

* Being younger than 3 years old and older than 6 years old,
* Children who received medical intervention in the last 24 hours,
* Children with any speech, hearing, psychological or neurological problems,
* Children who do not speak Turkish as their native language,
* Children and their parents who do not agree to participate in the research.

Primary outcomes:
measure: Children's emotional manifestation
timeFrame: one minute before nasopharyngeal swabbing, when nasopharyngeal swabbing begins, one minute after nasopharyngeal swabbing
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Maltepe University
Study officials:
affiliation: Maltepe University
name: Zeynep Erkut, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Acıbadem Hospital
name: Melisa Şengül
role: PRINCIPAL_INVESTIGATOR
References: