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Effectiveness of Play Interventions on Anxiety Among Hospitalized Children

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Play interventions
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Play interventions, anxiety

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental group

    Comparison group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    July 17, 2017
    Last Updated
    July 18, 2017
    Sponsor
    Maharishi Markendeswar University (Deemed to be University)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03222063
    Brief Title
    Effectiveness of Play Interventions on Anxiety Among Hospitalized Children
    Official Title
    A Study to Assess the Effectiveness of Play Interventions on Anxiety Among Hospitalized Children in Selected Hospital of Yamuna Nagar, Haryana
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maharishi Markendeswar University (Deemed to be University)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety
    Keywords
    Play interventions, anxiety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Comparison group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Play interventions
    Intervention Description
    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 Outcome Measure Information:
    Title
    Structured anxiety rating scale
    Description
    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).
    Time Frame
    05 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ms. Eenu Rani, M.Sc.Nursing
    Organizational Affiliation
    Maharishi Markandeshwar University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23078405
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23845098
    Citation
    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.
    Results Reference
    background

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    Effectiveness of Play Interventions on Anxiety Among Hospitalized Children

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