The Effect of Therapeutic Play on Children's Pain and Fear and Parents and Students' Satisfaction Levels

NCT06593002 | Completed

• 1 other identifier: SelcukUni2525
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Behavior; Pain; Anxiety; Anxiety and Fear

Keywords

Pain; Anxiety; Children; Nursing Student; therapeutic play

Outcome Measures

Primary Outcomes (3)

• Child and Parent Information Form

  This form, developed by the researcher in line with the literature, was created to determine the descriptive characteristics of children and parents receiving inpatient treatment. This form was filled out by the parents of the children receiving inpatient treatment, using a face-to-face interview technique, half an hour before the treatment.

  First measurement: 30 minute before treatment

• Wong-Baker Pain Scale

  It was developed by Wong and Baker in 1988. Patients' pain levels are evaluated by numbering their facial expressions. The numbering is as follows; "0" No pain, "1" A little pain, "2" A little more, "3" A lot more, "4" Quite a lot, "5" The most severe pain level. An increase in the score indicates that the severity of the pain also increases. This form was filled just before treatment.

  First measurement: Just before treatment

• Child Fear Scale

  It was developed by McMurtry and his colleagues to measure the fear levels of children aged 4-10. The scale is used to measure the child's fear level. The CQ is a scale that evaluates between 0-4, consisting of five drawn facial expressions ranging from a neutral expression (0=no fear) to a frightened face (4=severe fear). This form was filled just before treatment.

  First measurement: Just before treatment

Secondary Outcomes (4)

• Wong-Baker Pain Scale

  Second measurement: within five minutes after the treatment is completedAfter treatment

• Child Fear Scale

  Second measurement: within five minutes after the treatment is completed

• Student Satisfaction Survey

  Within five minutes after the treatment is completed

• Parent Satisfaction Survey

  Within five minutes after the treatment is completed

Study Arms (2)

Experimental: Therapeutic play

EXPERIMENTAL

Children in the experimental group received a therapeutic video game intervention in addition to the pre-treatment routine.

Behavioral: Therapeutic play

Control group

NO INTERVENTION

Children in the control group underwent routine clinical practice. No other intervention was performed.

Interventions

Therapeutic play BEHAVIORAL

The children in the experimental group were given a therapeutic toy designed for them by the student nurse half an hour before the treatment, the toy and game were introduced, and they were allowed to play with this toy for half an hour, accompanied by the student nurse.

Experimental: Therapeutic play

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30362982 RESULT

• 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.

  PMID: 31969473 RESULT

• 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.

  PMID: 26969158 RESULT

MeSH Terms

Conditions

Child Behavior; Pain; Anxiety Disorders

Interventions

Play Therapy

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sibel Küçükoğlu

  Selcuk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: April 15, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TU (1)