NCT07433296

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 17, 2026

Last Update Submit

February 21, 2026

Conditions

Keywords

painanxietychildsurgery

Outcome Measures

Primary Outcomes (3)

  • The Modified Yale Preoperative Anxiety Scale-Child Version (mYPAS-C)

    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.

    Baseline (30 minutes before surgery) and immediately before anesthesia induction

  • Children's Anxiety Meter-State (CAM-S)

    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

    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

Study Arms (2)

Experimental Group (Sand Play)

EXPERIMENTAL

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.

Behavioral: Sand Play Therapy

Control Group

NO INTERVENTION

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.

Interventions

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.

Experimental Group (Sand Play)

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 7 and 10 years
  • Scheduled for tonsillectomy surgery
  • Able to communicate verbally

You may not qualify if:

  • History of previous surgery
  • Diagnosed neurological or developmental disorders
  • Presence of chronic disease
  • Postoperative physiological instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun Training and Research Hospital

Samsun, Samsun, 55090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativePainAnxiety Disorders

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsMental Disorders

Study Officials

  • Esra TURAL BÜYÜK, Assoc. Prof

    Ondokuz Mayıs University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Study sample was assigned to experimental and control groups with simple randomization method. Both groups are followed simultaneously from the preoperative period through the postoperative assessment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Philosophy Registered Nurse

Study Record Dates

First Submitted

February 17, 2026

First Posted

February 25, 2026

Study Start

October 1, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

The individual participant data will not be shared to protect participant privacy and maintain confidentiality as per the ethical committee approval.

Locations