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Completed

NCT Number: NCT07433296

THE EFFECT OF SANDPLAY THERAPY ON THE ANXİETY AND PAİN LEVELS OF CHİLDREN DURİNG PREOPERATİVE PERİOD

This randomized controlled trial aims to investigate the effects of preoperative sand play therapy on anxiety and pain levels in school-aged children (7-10 years old). The study was conducted with 68 children undergoing tonsillectomy, divided into an experimental group (sand play intervention) and a control group (routine care). Anxiety levels were measured using the Child Anxiety Scale-State (CAAS) and the Yale Modified Preoperative Anxiety Scale (mYPAS), while pain levels were assessed using the Wong-Baker Faces Pain Rating Scale. The study evaluates whether sand play before surgery is an effective non-pharmacological method for reducing preoperative anxiety and postoperative pain.

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Key information

Conditions

Tonsillectomy Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Preoperative Anxiety Signs and Symptoms

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsun Training and Research Hospital

Samsun, 55090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sand Play Therapy

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Wong Baker Faces Pain Rating Scale

    Time frame: 1 hour after surgery

    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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

THE EFFECT OF SAND PLAY METHOD APPLİED TO CHİLDREN İN THE PRE-OPERATİVE PERİOD ON CHİLDREN'S ANXİETY AND PAİN LEVELS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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