The Effect of Therapeutic Play During Peripheral Intravenous Catheterisation

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Completed
CT.gov ID
NCT05823324
Collaborator
(none)
120
2
2
4
60
15.1

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Therapeutic play group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of Therapeutic Play on Children's Pain, Anxiety, and Mothers' Anxiety During Peripheral Intravenous Catheterisation
Actual Study Start Date :
Feb 1, 2020
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Change from before in pain on the FLACC Scale at during peripheral intravenous catheterisation [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.

  2. Change from before in anxiety on the CEMS Scale at during peripheral intravenous catheterization [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

Secondary Outcome Measures

  1. Change from before in mothers' anxiety on STAI scale at during peripheral intravenous catheterization [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 3-6 year-old children,

  • had no mental disability,

  • were able to communicate,

  • and had mothers volunteered to participate

Exclusion Criteria:
  • none

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University-Cerrahpaşa Istanbul Turkey 34381
2 Seda Caglar Istanbul Turkey 34381

Sponsors and Collaborators

  • Istanbul University - Cerrahpasa (IUC)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seda Caglar, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
ClinicalTrials.gov Identifier:
NCT05823324
Other Study ID Numbers:
  • SeCaglar
First Posted:
Apr 21, 2023
Last Update Posted:
Apr 21, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seda Caglar, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2023