The Effect of Therapeutic Play on Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction

May 10, 2024 updated by: Sibel Küçükoğlu, Selcuk University

The Effect of Therapeutic Play on Pre-Treatment Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction

In this study, the effect of the therapeutic game applied before treatment on pain, fear, anxiety and physiological parameters and the satisfaction of the parents was investigated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Therapeutic play is defined as activities structured in accordance with children's age and development, or as a set of interventions to improve the well-being of children in the hospital environment. This method reduces the stress of illness or hospitalization, uses play as a means of self-expression and supports the development of positive coping mechanisms in pediatric patients. In the literature, it is seen that therapeutic play methods such as listening to music, drawing, reading stories, puppets, dolls, virtual reality tools, cartoon applications, watching videos and playing video games are used to reduce the child's pain and anxiety about invasive procedures. Studies conducted to reduce the interactions between children in the same environment during their treatment and care are quite limited. No study has been found to examine the effect of methods that jointly block/reduce vision and hearing during treatment and care on anxiety, fear and pain in children treated together in pediatric clinics.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey
        • Selcuk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

For the Child;

Inclusion Criteria:

  • Being in the 3-6 age group,
  • At least one day of inpatient treatment in the pediatric clinics of Selçuk Medical Faculty Hospital
  • At least one invasive intervention in the treatment plan
  • To be able to understand and speak Turkish
  • Staying in a room with at least two beds

Exclusion Criteria:

  • Having a neurological disorder
  • Not having a parent as a companion
  • Receiving oral treatment only
  • Hearing and vision problems
  • Single bed capacity room or isolated room

For the Parent

Inclusion Criteria:

  • Staying with their child as a constant companion
  • To be able to understand and speak Turkish
  • Accepting to participate in the study

The exclusion criteria:

  • Not staying with your child all the time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic play group
Children in the experimental group received a therapeutic video game intervention in addition to the pre-treatment routine.
Behavioral: Video game with headset
Half an hour before the first treatment in the morning, the screens around the patients' beds were closed by the researcher. The child was asked to choose one of the introduced games and the game he/she chose from the tablet was turned on. Children were asked to wear headphones for sound isolation and the sound was adjusted at the appropriate decibel setting. Half an hour before the treatment, children were allowed to play the video game until the treatment without any different warning. Physiologic Parameter Assessment Form, Child Anxiety and Fear Scale, Child Pain Scale were filled by the researcher 1 minute before and 1 minute after the procedure. Finally, Parental Satisfaction Scale was completed at the end of the intervention.
No Intervention: Control Group
Children in the control group underwent routine clinical practice. No other intervention was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive Characteristics Information Form
Time Frame: First measurement: 30 minute before treatment
A descriptive characteristics information form for parents and children was prepared by the researchers in line with the literature and the data of both the experimental and control groups were collected before the intervention.
First measurement: 30 minute before treatment
Physiological Parameter Monitoring Form
Time Frame: First measurement: 1 minute before treatment
The descriptive characteristics form was based on a literature review by the investigator. Heart rate (min), oxygen saturation (SpO2%), blood pressure (mmHg) and respiratory rate (min) were measured 1 minute before treatment administration.
First measurement: 1 minute before treatment
Children's State Anxiety and Children's Fear Scale
Time Frame: First measurement: 1 minute before treatment
Children's State Anxiety and Children's Fear Scale was developed by McMurtry et al. in 2011. The scale was designed to measure the fear levels of children aged 4-10 years. The scale was translated into Turkish by Gerçeker et al. in 2018 and the validity-reliability coefficient was found to be 0.89. The scale score is formed by scoring five drawn facial expressions (0=no fear to 4=severe fear) shown visually to the child. Anxiety and fear scores of the child were scored one minute before the treatment.
First measurement: 1 minute before treatment
Visual Analog Scale
Time Frame: First measurement: 1 minute before treatment
Visual Analog Scale (VAS) was developed by Wong and Baker in 1988. Patients' pain levels are evaluated by scoring with facial expressions. It is used in children who have the ability to communicate and are conscious. The scale has 6 faces that are scored between 0 and 5. In scoring, the child chooses the face that best expresses him/her and "0" indicates no pain, "1" indicates a little pain, "2" indicates a little more pain, "3" indicates more pain, "4" indicates quite a lot of pain and "5" indicates the most severe pain level. One minute before the treatment, the child's pain is scored by VAS.
First measurement: 1 minute before treatment
PedsQL Health Care Satisfaction Scale
Time Frame: First measurement: After treatment
The PedsQL Health Care Satisfaction Scale was developed by J.W. Varni in 1999. Turkish adaptation of the scale was conducted by Ulus and Kublay in 2012. The scale consists of 25 items with 6 subheadings: emotional support, information, general satisfaction, communication, family involvement and technical skills. The scale is on a five-point scale and each item is rated on a scale of 0 to 4 and is evaluated as "Never satisfied (0)", "Sometimes satisfied (1)", "Most of the time satisfied (2)", "Almost always satisfied (3)" and "Always satisfied (4)". A high score indicates an increase in parental satisfaction.
First measurement: After treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological Parameter Monitoring Form
Time Frame: Second measurement: 1 minute after treatment
Heart rate (min), oxygen saturation (SpO2%), blood pressure (mmHg) and respiratory rate (min) were measured one minute after treatment administration.
Second measurement: 1 minute after treatment
Children's State Anxiety and Children's Fear Scale
Time Frame: Second measurement: 1 minute after treatment
1 minute after the treatment, the child's anxiety and fear score was scored again.
Second measurement: 1 minute after treatment
Visual Analog Scale
Time Frame: Second measurement: 1 minute after treatment
One minute after the treatment, the child's pain score was scored again
Second measurement: 1 minute after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selcuk University

Investigators

  • Principal Investigator: Sibel Kucukoglu, Prof, Selcuk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Actual)

April 15, 2024

Study Completion (Actual)

May 10, 2024

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SelcukUni2544

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It will be shared after the article is published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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