- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433296
THE EFFECT OF SANDPLAY THERAPY ON THE ANXİETY AND PAİN LEVELS OF CHİLDREN DURİNG PREOPERATİVE PERİOD
THE EFFECT OF SAND PLAY METHOD APPLİED TO CHİLDREN İN THE PRE-OPERATİVE PERİOD ON CHİLDREN'S ANXİETY AND PAİN LEVELS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this randomized controlled study was to evaluate the effect of sand play therapy administered during the preoperative period on anxiety and postoperative pain levels in children undergoing tonsillectomy.
Children aged 7 to 10 years were randomly assigned to either the intervention group (sand play therapy) or the control group (routine care). Preoperative anxiety levels were assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS-C) at baseline (30 minutes before surgery) and immediately prior to anesthesia induction. Postoperative pain was measured 1 hour after surgery using the Wong-Baker Faces Pain Rating Scale. In addition, state anxiety levels were evaluated using the CAM-S scale on the evening before surgery, 30 minutes prior to surgery, and 1 hour postoperatively.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Samsun
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Samsun, Samsun, Turkey (Türkiye), 55090
- Samsun Training and Research Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion criteria
- Children aged between 7 and 10 years
- Scheduled for tonsillectomy surgery
- Able to communicate verbally
- No visual, hearing, or cognitive impairment Exclusion criteria
- History of previous surgery
- Diagnosed neurological or developmental disorders
- Presence of chronic disease
- Postoperative physiological instability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group (Sand Play)
Unlike the control group, a therapeutic play program was applied to the children one hour before surgery by the certified researcher in this group. The therapeutic play program was conducted in the child's room for 30 minutes. Materials used for the play included colored sand, a sand tray, a sand shaping set, a doll, a toy car, a mask, a cap, a toy doctor's set, colored pencils, drawing paper, and an ice cream cone. The child was given the opportunity to ask questions about things they were curious about to gain their trust. Then, the sand tray was filled with sand having the color chosen by the child, and the toys they selected were placed inside for them to play (the sand was given to each child in individual packets, and the materials were sterilized). Faces Pain Rating Scale (Wong Baker) was applied to assess pain following the surgery in both groups. The child and the parent were asked to complete Children's Anxiety Meter-State. |
This randomized controlled trial represents an advancement in considering sand play as an intervention applied in the pre-operative period, and it enhances its applicability and clinical success.
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|
No Intervention: Control Group
The parents who agreed to participate in the study completed an "Informed Consent Form" and a "SocioDemographic Information Form" through face-to-face interviews in the evening before the surgery.
An educational booklet was given to the families, and they were asked to read it to their child before the surgery.
During the preoperative routine care, the child and family received necessary information about the pre- and post-operative procedures from the ward nurse and the researcher, including vital sign monitoring of the child and the medication prescribed by the physician.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Modified Yale Preoperative Anxiety Scale-Child Version (mYPAS-C)
Time Frame: Baseline (30 minutes before surgery) and immediately before anesthesia induction
|
The Modified Yale Preoperative Anxiety Scale - Child Version (mYPAS-C) is an observational tool used to assess preoperative anxiety in children.
The scale consists of 22 items and scores range from 23.33 to 100, with higher scores indicating higher levels of anxiety.
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Baseline (30 minutes before surgery) and immediately before anesthesia induction
|
|
Children's Anxiety Meter-State (CAM-S)
Time Frame: The evening before surgery, 30 minutes before surgery, and 1 hour after surgery
|
The Children's Anxiety Meter - State (CAM-S) is a self-report scale used to assess state anxiety in children.
The scale ranges from 0 to 10, with higher scores indicating higher levels of anxiety.
|
The evening before surgery, 30 minutes before surgery, and 1 hour after surgery
|
|
Wong Baker Faces Pain Rating Scale
Time Frame: 1 hour after surgery
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The Wong-Baker Faces Pain Rating Scale is used to assess pain intensity in children.
The scale consists of six faces representing increasing pain levels and scores range from 0 to 10, with higher scores indicating greater pain intensity.
|
1 hour after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Esra TURAL BÜYÜK, Assoc. Prof, Ondokuz Mayıs University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMU-2022-588
- BAP04-B-2024-5060 (Other Grant/Funding Number: ONDOKUZ MAYIS UNIVERSITY BAP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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