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Completed

NCT Number: NCT03222063

Effectiveness of Play Interventions on Anxiety Among Hospitalized Children

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

The study exclude hospitalized children who were:

  • 1. treated as outpatient

Treatment and study plan

Play interventions

Other

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.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Maharishi Markendeswar University (Deemed to be University)

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2017
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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