The Effect of Therapeutic Play During Peripheral Intravenous Catheterisation

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05823324
• Other study ID #: SeCaglar
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

• 3-6 year-old children,

• had no mental disability,

• were able to communicate,

• and had mothers volunteered to participate

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

Behavioral:
• Therapeutic play group
The dramatization method with teddy bear, one of the TP methods, was applied during the PIVC intervention

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul
Turkey	Seda Caglar	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from before in pain on the FLACC Scale at during peripheral intravenous catheterisation	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
Primary	Change from before in anxiety on the CEMS Scale at during peripheral intravenous catheterization	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	Change from before in mothers' anxiety on STAI scale at during peripheral intravenous catheterization	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