The Effect of Therapeutic Play During Peripheral Intravenous Catheterisation

April 9, 2023 updated by: Seda Caglar, Istanbul University - Cerrahpasa (IUC)

The Effect of Therapeutic Play on Children's Pain, Anxiety, and Mothers' Anxiety During Peripheral Intravenous Catheterisation

Therapeutic play (TP) is a non-pharmacological method used in the pain management in children. This study was conducted to determine the effect of therapeutic play on children's pain, anxiety, and mothers' anxiety during peripheral intravenous catheterisation (PIVC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The hospitalisation of children due to an acute or chronic illness interrupts play, disrupts their daily routines, places them in an unfamiliar environment, forces them to encounter with unfamiliar people, exposes them to invasive procedures, and makes them suffer from pain and anxiety. Peripheral intravenous catheterisation (PIVC) is probably the most common procedure performed in paediatric clinics. It has been estimated that 80% of hospitalised children have a peripheral intravenous catheter in place. PIVC is a painful and traumatic experience that children usually go through for the first time and frequently during the hospitalisation. This experience of children impairs effective communication between them and healthcare professionals and also causes problems in adaptation to the care and treatment process in the hospital setting. As one of the non-pharmacological pain relief methods, therapeutic play (TP) is a distraction that is defined as "the directed use of toys and materials, which can facilitate children to gain knowledge about the environment and the world they live in, to improve their perceptions thereof and to gain control, for a specific purpose". In order to call play with a child who is hospitalised as therapeutic, the play should encourage children to express their feelings and thoughts during the hospitalisation, assume an educational role in their positive or negative hospital experiences, and bring psychosocial and physical benefits. Children could be told facts such as the hospitalisation, the procedures to be followed and the time when this procedure would end through therapeutic play

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Istanbul, Turkey, 34381
        • Istanbul University-Cerrahpaşa
      • Istanbul, Turkey, 34381
        • Seda Caglar

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 3-6 year-old children,
  • had no mental disability,
  • were able to communicate,
  • and had mothers volunteered to participate

Exclusion Criteria:

  • none

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Therapeutic play
The therapeutic play method with the teddy bear during PIVC was applied in this group
Behavioral: Therapeutic play group
The dramatization method with teddy bear, one of the TP methods, was applied during the PIVC intervention
No Intervention: Control
The standard procedure of the clinic was applied in the control group. The routine invasive procedure of the clinic, the mothers accompany their children and are involved in the procedure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from before in pain on the FLACC Scale at during peripheral intravenous catheterisation
Time Frame: data collected just before and within 5 min after peripheral intravenous catheterization procedure
The FLACC Scale was used to assess the pain scores of children. The scale is scored between 0 and 10 points indicating "0": the child is relaxed and calm, "1-3": the child is mildly uncomfortable, "4-6": the child has moderate pain and "7-10": the child has severe pain.
data collected just before and within 5 min after peripheral intravenous catheterization procedure
Change from before in anxiety on the CEMS Scale at during peripheral intravenous catheterization
Time Frame: data collected just before and within 5 min after peripheral intravenous catheterization procedure
The CEMS scale was used to evaluate the anxiety scores of children.This scale, which consists of 5 different categories and 25 items, was used to evaluate the anxiety of children before and during medical procedures. Total score ranges between 5 and 25 points
data collected just before and within 5 min after peripheral intravenous catheterization procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from before in mothers' anxiety on STAI scale at during peripheral intravenous catheterization
Time Frame: data collected just before and within 5 min after peripheral intravenous catheterization procedure
The STAI scale was used to assess the anxiety mean scores of the mothers.This self-assessment scale with brief statements comprises a total of 40 items, including 20 items in each of two sections, the "state anxiety inventory" and the "trait anxiety inventory". The 'State Anxiety Inventory' was designed to determine what was felt at that moment and the 'Trait Anxiety Scale' was designed to determine what was felt in the last week.
data collected just before and within 5 min after peripheral intravenous catheterization procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SeCaglar

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

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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