The Effect of Therapeutic Play on Children's Anxiety and Fear Before Lumbar Puncture

NCT06199206 | Completed

• 1 other identifier: E-46059653-050.99-232013695
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conducted with the randomized controlled experimental method. The children who attended the pediatric department will divide into two groups via randomization in the computer environment. After random selection, children in the intervention group will play a therapeutic game before the lumbar puncture procedure. Children in the control group will not undergo any procedure before the lumbar puncture procedure. Parents will be present with their children in both groups during the procedure. While the child's anxiety and fear level is measured, the parent's anxiety level will also be measured.

Conditions

Anxiety and Fear

Keywords

theraputic play; lumbar punction; children

Outcome Measures

Primary Outcomes (2)

• Children's Anxiety Level (State-Trait Anxiety Inventory for Children-CDSSI)

  Developed by Spielberger (1976), this performance has two optional subscales for state and trait anxiety, each consisting of 20 questions. Points are given as 0, 1 or 2 depending on the protection of the substance. Situational anxiety; It consumes the individual's free anxiety, covering specific circumstances at a decisive time, and may vary according to external factors. Trait anxiety reflects the individual's general absence and the individual's anxieties in general. Cronbach's Alpha was 0.82, reflecting state anxiety. In the study; If trait anxiety will not be used, the section on state anxiety appropriate to the learning method will be used. 20 questions are asked and there are 3 options for each question. Questions will earn between one and three points. The highest score that can be obtained from the scale is 60 and the lowest score is 20. The scale score is reached at the point where state anxiety occurs.

  45 minutes before lumbar punction, 10 minutes before lumbar punction and 1 hour after lumbar punction

• Children's Fear Level (Children's Fear Scale-CFS)

  It is used to measure the child's fear level. The one-item scale consists of 5 facial expressions, regardless of gender. It is a scale that evaluates between 0 and 4, consisting of showing five drawn facial expressions ranging from neutral expression (0 = no anxiety) to scared face (4 = severe anxiety). It was created based on the Faces Anxiety Scale, developed by Mc Kinley et al. (2003) to measure the fear or anxiety of adults in the intensive care unit. Cronbach's alpha value was reported to be 0.89.

  45 minutes before lumbar punction, 10 minutes before lumbar punction and 1 hour after lumbar punction

Secondary Outcomes (1)

• Mother's Anxiety Level (Beck Anxiety Scale)

  45 minutes before lumbar punction, 10 minutes before lumbar punction and 1 hour after lumbar punction

Study Arms (2)

Intervention Group

EXPERIMENTAL

Before the procedures, therapeutic games will be played with the children and people of the intervention groups with eLPi dolls and other play materials prepared in accordance with anatomy. The parent will be with the child during this game, which will be played in his/her own room.

Other: Theraputic Play

Control Group

NO INTERVENTION

No therapeutic play will be made to children. Children will be verbally informed about the lumbar puncture.

Interventions

Theraputic Play OTHER

Before the procedures, therapeutic games will be played with the children and people of the intervention groups with eLPi dolls and other play materials prepared in accordance with anatomy. The parent will be with the child during this game, which will be played in his/her own room.

Intervention Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 6 and 12,
• Children do not have any work, speech, mental or mathematical problems,
• Before LP was performed, children,

You may not qualify if:

• Children under 6 years old and over 12 years old,
• Children with hearing, speech, mental or neurological problems,
• Children who have had LP before,
• Parents and their children who do not agree to participate in the research will be excluded from the research.

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Maltepe University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Zeynep Erkut, PhD

  Maltepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: January 15, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)