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CompletedNCT06262984Updated Mar 15, 2024

Therapeutic Play Before Nasopharyngeal Swabbing in Children

An interventional study of Therapeutic Play in Behavior, Coping, sponsored by Maltepe University. Completed at 1 site in Turkey. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Maltepe University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Behavior, Coping

Keywords

  • Child
  • Nasopharyngeal swab
  • Therapeutic play
  • Emotional manifestation
03

In context

Lead sponsor

Maltepe University is the lead sponsor of 62 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherTherapeutic 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: one minute before nasopharyngeal swabbing, when nasopharyngeal swabbing begins, one minute after nasopharyngeal swabbing

07

Study locations

1 site
  • Maltepe University
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06262984
Lead sponsor
Maltepe University
Responsible party
Zeynep Erkut (Assist. Prof., Maltepe University) — Principal investigator
First posted
Feb 16, 2024
Start date
Feb 19, 2024
Primary completion
Mar 13, 2024
Completion
Mar 13, 2024
Last update
Mar 15, 2024

Study contacts

Zeynep Erkut, PhD
principal investigator · Maltepe University
Melisa Şengül
principal investigator · Acıbadem Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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