NCT03222063

Brief Summary

The study evaluates the effectiveness of play interventions on anxiety among hospitalized children in selected hospital of Yamuna Nagar, Haryana. Quasi experimental approach was adopted. 60 (30 in experimental and 30 in comparison)hospitalized children were selected by purposive sampling technique.Hospitalized children in experimental group were provided play interventions whereas the children in Comparison group received only usual medical and nursing care.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable anxiety

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

July 17, 2017

Last Update Submit

July 18, 2017

Conditions

Keywords

Play interventions, anxiety

Outcome Measures

Primary Outcomes (1)

  • Structured anxiety rating scale

    It include: * Total 30 items and consists of 4 areas that includes apprehension, Nervousness/tension, discomfort and irritability. * The maximum score is 90 and minimum 0. The level of anxiety were categorized into 4 categories as shown in table no. 3.3 Anxiety among hospitalized children was measured by using structured anxiety rating scale which was categorized as no anxiety(0-23), mild to moderate(24-45), severe(46-68) and panic anxiety(69-90).

    05 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental Group: Experimental group consists of 30 hospitalized children.In Experimental group after taking pretest on 1st day play interventions were introduced to the children and instructions regarding the way to play with all the interventions were provided to the children. Though all the children were free to choose the play yet the younger children were given simple and easy play interventions such as drawing, coloring etc. to obtain more sensory experience whereas the older children were offered play interventions such as puzzle, building blocks, ludo etc. with high cognitive demand. The play interventions were administered for 1 hour daily for continuous 5 days.Post test assessment of anxiety was done on 5th day.

Other: Play interventions

Comparison group

NO INTERVENTION

Comparison Group: 30 hospitalized children were selected by purposive sampling in comparison group. Pretest anxiety was measured on 1st day . No intervention was administered. only usual medical and nursing care was administered to the hospitalized children. Post test assessment of anxiety was done on 5th day.

Interventions

The following play were included in play interventions i.e building blocks, paint, puzzles, crayons, doctor set, ludo, snake and ladder. All hospitalized children in experimental group received play interventions at bed side. Taking into consideration the busy clinical setting, each participant received continuously 1 hour of hospital play interventions each day for continuous 5 days. Although the hospitalized children were free to choose according to their choice but still the younger children would be engaged in play such as doctor set, Drawing etc. to obtain more sensory experience and older children were offered play interventions such as puzzle, building blocks, ludo etc.with high cognitive demand.

Experimental group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The study include hospitalized children who were:
  • aged 6-12 yrs. admitted in the pediatric general medical unit.
  • anxious due to hospitalization.
  • willing to participate in the study.
  • alert, oriented, comprehend and able to speak and understand Hindi language.

You may not qualify if:

  • The study exclude hospitalized children who were:
  • \. treated as outpatient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Potasz C, De Varela MJ, De Carvalho LC, Do Prado LF, Do Prado GF. Effect of play activities on hospitalized children's stress: a randomized clinical trial. Scand J Occup Ther. 2013 Jan;20(1):71-9. doi: 10.3109/11038128.2012.729087. Epub 2012 Oct 18.

    PMID: 23078405BACKGROUND
  • Nabors L, Bartz J, Kichler J, Sievers R, Elkins R, Pangallo J. Play as a mechanism of working through medical trauma for children with medical illnesses and their siblings. Issues Compr Pediatr Nurs. 2013 Sep;36(3):212-24. doi: 10.3109/01460862.2013.812692. Epub 2013 Jul 11.

    PMID: 23845098BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Ms. Eenu Rani, M.Sc.Nursing

    Maharishi Markandeshwar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student, M.Sc. Nursing

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 19, 2017

Study Start

November 1, 2016

Primary Completion

January 1, 2017

Study Completion

June 1, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07