Therapeutic Play Before Nasopharyngeal Swabbing in Children

The Effect of the Therapeutic Play Applied Before Nasopharyngeal Swaping on Children's Emotional Manifestation in the 3-6 Years Old Group

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.

Study Overview

• Status: Completed
• Conditions: Behavior, Coping
• Intervention / Treatment: Other: Therapeutic Play

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Maltepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic Play Group; 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. The Children's Emotional Manifestation Scale (CEMS) will be evaluated and scored by the researcher and the observing nurse.	Other: Therapeutic Play; 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. The Children's Emotional Manifestation Scale (CEMS) will be evaluated and scored by the researcher and the observing nurse.
No Intervention: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's emotional manifestation	The child's emotional response will be evaluated with the Children's Emotional Manifestation Scale (CEMS) by the researcher and the observing nurse before, during and after the procedure. In the scale, emotional indicators are evaluated according to 5 parameters (facial expression, voice, activity, interaction, cooperation level). These five parameters are scored from 1 to 5, with the lowest score being '5' and the highest being '25'. A higher scale score indicates that the child showed more negative emotional behavior during the procedure.	one minute before nasopharyngeal swabbing, when nasopharyngeal swabbing begins, one minute after nasopharyngeal swabbing

Collaborators and Investigators

• Sponsor: Maltepe University
• Investigators: Principal Investigator: Zeynep Erkut, PhD, Maltepe University; Principal Investigator: Melisa Şengül, Acıbadem Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Actual): March 13, 2024
• Study Completion (Actual): March 13, 2024

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Child; Nasopharyngeal swab; Therapeutic play; Emotional manifestation
• Other Study ID Numbers: 2023/21-754

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No