Effectiveness of Play Interventions on Anxiety Among Hospitalized Children

July 18, 2017 updated by: Pooja saharan, Maharishi Markendeswar University (Deemed to be University)

A Study to Assess the Effectiveness of Play Interventions on Anxiety Among Hospitalized Children in Selected Hospital of Yamuna Nagar, Haryana

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

TSetting was selected by randomization (by lottery method) first selected two rooms from General Pediatric Wards were coded as E1 (Experimental 1) and E2 (Experimental 2) whereas next two were coded as C1 (Comparison 1) and C2 (Comparison 2).

From the selected settings 60 subjects (30 in experimental and 30 in Comparison) were selected by purposive sampling technique. Assessment of anxiety (Pre-test) of the hospitalized children admitted in Aashirwad Hospital was done in experimental group and Comparison group on 1st day. In Experimental group after taking pretest 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 from day 1 to day 5 whereas in Comparison group all the subjects were given usual general nursing and medical care for continuous 5 days. No intervention was administered to the comparison group. Posttest anxiety was assessed on 5th day.

Intervention to the control group was given after the accomplishment of Post test for ethical consideration.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The study include hospitalized children who were:

    1. aged 6-12 yrs. admitted in the pediatric general medical unit.
    2. anxious due to hospitalization.
    3. willing to participate in the study.
    4. alert, oriented, comprehend and able to speak and understand Hindi language.

Exclusion Criteria:

The study exclude hospitalized children who were:

  • 1. treated as outpatient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group

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
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.
No Intervention: Comparison group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Structured anxiety rating scale
Time Frame: 05 minutes

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maharishi Markendeswar University (Deemed to be University)

Investigators

  • Study Director: Ms. Eenu Rani, M.Sc.Nursing, Maharishi Markandeshwar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

July 17, 2017

First Submitted That Met QC Criteria

July 18, 2017

First Posted (Actual)

July 19, 2017

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 785

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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