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

NCT02832050 | Withdrawn

• 1 other identifier: 197779
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Anxiety; Rheumatology

Keywords

play; therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Observer procedure-related anxiety VAS score - completed by parent

  1 year

• Procedure-related coping VAS score - completed by child

  1 year

• Procedure-related pain VAS score - completed by child

  1 year

• Patient experience VAS score - completed by child and parent separately

  1 year

Study Arms (2)

Intervention

EXPERIMENTAL

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

Comparator

PLACEBO 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

Interventions

Play therapy BEHAVIORAL

See previous description of play therapy intervention arm.

Intervention

Standard of care BEHAVIORAL

See previous description of comparator arm.

Comparator

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alder Hey Children's NHS Foundation Trust: lead

Study Sites (1)

Alder Hey Children's Hospital

Liverpool, Merseyside, L12 2AP, United Kingdom

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Play Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael Beresford

  Alder Hey Children's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: July 13, 2016
• Study Start: March 8, 2016
• Primary Completion: August 19, 2019
• Study Completion: September 30, 2019
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

GB (1)