The Effect of Therapeutic Play on Children's Pain, Anxiety, and Mothers' Anxiety During Peripheral Intravenous Catheterisation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 4
- Primary Endpoint
- Change from before in pain on the FLACC Scale at during peripheral intravenous catheterisation
Study Overview
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).
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 6 Years (Child)
- Sex
- 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
- Not provided
Outcomes
Primary Outcomes
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.
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
Secondary Outcomes
- 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)
Investigators
Seda Caglar
Principal Investigator
Istanbul University - Cerrahpasa (IUC)
