PLAY Therapy Intervention: Re-Modelling Patient Experience (The PLAYTIME Study) (PLAYTIME)

Study synopsis Objectives

• To determine whether delivering a semi-structured play therapy intervention can improve procedure-related anxiety / ability to cope with a procedure / procedure-related pain for children and young people.
• To determine whether delivering a semi-structured play therapy intervention can improve patient experience of blood monitoring.

Patients

• Patients aged 5 - 17 years who are under the care of the rheumatology team.
• Patients expected to require at least two blood tests during a 12 week period. Design
• Recruitment over 24 weeks with each child in the study for a 12 week period.
• 20 patients will receive play therapy intervention as outlined in the play therapy intervention for blood tests.
• 20 patients will be the comparator group. They will be offered standard care for blood tests.
• All children will be offered local anaesthetic cream for each blood test. Blood tests will be performed by venepuncture unless specifically requested otherwise by patient.
• All children will complete outcome measures at baseline, beginning and end of each procedure session and at completion of the study at 16 weeks.

Outcome Measures

• Procedure-related anxiety visual analogue scale (VAS) score - completed by child
• Observer procedure-related anxiety VAS score - completed by parent
• Procedure-related coping VAS score - completed by child
• Procedure-related pain VAS score - completed by child
• Patient experience VAS score - completed by child and parent separately

Study Overview

• Status: Withdrawn
• Conditions: Pain; Anxiety; Rheumatology
• Intervention / Treatment: Behavioral: Play therapy; Behavioral: Standard of care

Detailed Description

Children and young people experience significant pain and distress related to procedures. There are many studies looking at psychological and pharmacological interventions demonstrating that these can reduce procedural-related pain and distress. Distraction is frequently studied and consistently demonstrated to reduce procedure-related pain and in some cases distress. It has also been shown that children choose different distractors, and this can be related to age and sex. Best practice for distraction should therefore include identifying and working with individual patient preferences and this can additionally help by giving children some control over the procedure. There are limited studies looking at other interventions such as preparation and parent positioning showing that these interventions can have a positive impact on distress and coping. Few trials examine effect of interventions over time and multiple procedures.

Play specialists provide therapeutic play for children undergoing procedures. They use a combination of psychological interventions alongside pharmacological interventions which includes preparation for the procedure, support during the procedure and post-procedure. However, whilst there is information about what play therapy should involve and which standards should be met, we are unaware of any specific framework of how this should be delivered.

Investigators have developed a semi-structured play therapy intervention, which is developed from standard play therapy theory and well-recognised techniques as well as expert experience. This play therapy intervention is designed to represent a gold standard of care for delivering play therapy to children requiring procedures. The intervention aims to deliver play therapy in a standardised fashion whilst utilising the skill of the play specialist to choose and implement techniques in an individualised approach to each child.

This study aims to deliver this semi-structured play therapy intervention and examine its impact on procedure-related anxiety, coping, pain and patient experience.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L12 2AP
      • Alder Hey Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Child or young person aged 5 to 17 years of age.
• Child under the care of the paediatric rheumatology team at Alder Hey Children's NHS Foundation Trust.
• Child must be expected to require at least 2 blood tests during the study period of 16 weeks as part of their routine care. All decisions regarding requirement for blood tests and/or procedures will be made solely on clinical grounds and not determined in any way by the study team.
• Sufficient time for assessment visit and preparation prior to first procedure.
• The parent or child if aged above 16 years of age has provided written, informed consent to participate in the study.
• The child aged less than 16 years has provided assent appropriate to their age.

Exclusion Criteria:

• Child unable to understand and complete Visual Analogue Scale (VAS) with support.
• Family unwilling to take part in study.
• Patient has previously received regular play therapy.
• Patient receiving psychology input for procedure-related anxiety or anxiety disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The play therapy intervention consists of a standard of care delivered by a play specialist. The play specialist delivers interventions aimed in assisting the child through the process of undergoing procedures. The intervention is semi-structured in order to facilitate a systematic approach which remains individualised and child-centred. The intervention requires patients to be classified as 'high risk' or 'low risk' for procedure-related anxiety. This is assessed for all patients at baseline based on parent and clinician opinion. The play specialist may re-classify patients at the initial assessment or at any point whilst working with the child. If this occurs, clear documentation of the rationale for this will be recorded. Patients classified as "high risk" receive additional preparation sessions as detailed in the standard of care.	Behavioral: Play therapy; See previous description of play therapy intervention arm.
Placebo Comparator: Comparator; The comparator group will receive standard care of patients having blood tests within the Trust, which does not include the specific intervention of a play therapist routinely. As part of standard care if a child becomes particularly distressed a clinician may make a decision to refer the child for play therapy. If this occurs during the study period the child will be referred to the play specialist delivering the intervention for the study. The child will then receive play therapy as in the described intervention. They will be excluded from the main analysis but data will still be collected and analysed descriptively.	Behavioral: Standard of care; See previous description of comparator arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure-related anxiety visual analogue scale (VAS) score - completed by child	Procedure-related anxiety visual analogue scale (VAS) score - completed by child	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observer procedure-related anxiety VAS score - completed by parent	Observer procedure-related anxiety VAS score - completed by parent can improve ability to cope with a procedure.	1 year
Procedure-related coping VAS score - completed by child	Procedure-related coping VAS score - completed by child	1 year
Procedure-related pain VAS score - completed by child	Procedure-related pain VAS score - completed by child	1 year
Patient experience VAS score - completed by child and parent separately	Patient experience VAS score - completed by child and parent separately	1 year

Collaborators and Investigators

• Sponsor: Alder Hey Children's NHS Foundation Trust
• Investigators: Principal Investigator: Michael Beresford, Alder Hey Children's NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2016
• Primary Completion (Actual): August 19, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: February 15, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimated): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: play; therapy
• Other Study ID Numbers: 197779