Effectiveness of Play Interventions on Anxiety Among Hospitalized Children

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03222063
• Other study ID #: 785
• Status: Completed
• Phase: N/A
• First received: July 17, 2017
• Last updated: July 18, 2017
• Start date: November 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Maharishi Markendeswar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maharishi Markendeswar University

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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