Anxiety and Fear Clinical Trial
Official title:
The Effect of Therapeutic Play on Children's Anxiety and Fear Levels and Parents' Anxiety Levels Before Lumbar Puncture Procedure in Children Aged 6 - 12 Years
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.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | June 15, 2024 |
Est. primary completion date | June 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria: - Children between the ages of 6 and 12, - Children do not have any work, speech, mental or mathematical problems, - Before LP was performed, children, - Inclusion of parents and children who do not agree to participate voluntarily. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Maltepe University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Maltepe University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Mother's Anxiety Level (Beck Anxiety Scale) | It is a Likert-type self-rating scale, developed by Aaron Beck (1988), consisting of 21 items and used to determine the frequency of anxiety symptoms experienced by individuals, with each item scored between "0 - 3". Cronbach's alpha value was reported to be 0.94. When the total score on the scale is between "0 - 7" points, anxiety is minimal, "8 - 15" points is mild, "16 - 25" points is moderate, and "26 - 63" points is severe. It is considered as anxiety. | 45 minutes before lumbar punction, 10 minutes before lumbar punction and 1 hour after lumbar punction |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04027933 -
Standard Patient Simulation in Nursing Students' Approach Toward Patients With Bipolar Disorder
|
N/A | |
Not yet recruiting |
NCT05614687 -
Art as Healing: A Community-informed Art-based Programme (CiAbP) for Reintegrating Ex-offenders Into Society in Nigeria
|
N/A | |
Completed |
NCT05828264 -
The Effect of "Quantum-Touch" on Pain, Fear, and Anxiety of the Children
|
N/A | |
Completed |
NCT04755998 -
Evaluating the Effect of the Use of Virtual Reality Headset in School Vaccinations
|
N/A | |
Completed |
NCT04299555 -
Assessment of Fears of Patients Standing at the Operating Block
|
||
Active, not recruiting |
NCT03993509 -
Effect of rTMS on Anxiety
|
N/A | |
Completed |
NCT06011668 -
EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN
|
N/A | |
Completed |
NCT05930015 -
Effects of Music Combined With Sports Games on Alleviating Psychological Stress, Anxiety and Mental Energy Among Adolescents During COVID-19 Pandemic in Lanzhou Gansu Province China
|
N/A | |
Recruiting |
NCT06004115 -
Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression
|
Phase 4 | |
Recruiting |
NCT06257186 -
Investigating the Effect of Art Therapy on Women With Fear of Childbirth During Pregnancy: A Mixed Method Study
|
N/A | |
Recruiting |
NCT03821779 -
Prefrontal Oscillations in Social Anxiety Disorder (POSAD)
|
N/A | |
Completed |
NCT06336811 -
Virtual Reality Distraction During Phlebotomy in Children
|
N/A | |
Recruiting |
NCT05548699 -
Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control
|
||
Recruiting |
NCT04406181 -
Psychological Well-being of Patients Awaiting for Cardiac Surgery During the COVID-19 Pandemic
|
N/A | |
Completed |
NCT04821960 -
Memory and Fear Study (Fear of Memory Loss Study)
|
N/A | |
Completed |
NCT04631172 -
Covid-19 Anxiety and Phobia Levels of the Parents
|
||
Active, not recruiting |
NCT04385732 -
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
|
N/A | |
Recruiting |
NCT05469412 -
Comparison of Pharmacological and Non-Pharmacological Interventions For Alleviating Preoperative Anxiety In Children
|
N/A | |
Completed |
NCT06189222 -
The Effect of Virtual Reality Glasses Used During Intravenous Catheter Insertion
|
N/A | |
Terminated |
NCT04582396 -
Stellate Ganglion Blockade to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors
|
N/A |