MedTrace Logo

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

NCT02832050 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-01-30

No results posted yet for this study

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

Interventions

BEHAVIORAL

Play therapy

See previous description of play therapy intervention arm.

BEHAVIORAL

Standard of care

See previous description of comparator arm.

Sponsors & Collaborators

  • Alder Hey Children's NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Michael Beresford · Alder Hey Children's NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-08
Primary Completion
2019-08-19
Completion
2019-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02832050 on ClinicalTrials.gov