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Clinical Trials/NCT07433296
NCT07433296CompletedNot Applicable

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

Ondokuz Mayıs University1 site in 1 country68 target enrollmentStarted: October 1, 2024Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
68
Locations
1
Primary Endpoint
The Modified Yale Preoperative Anxiety Scale-Child Version (mYPAS-C)

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
7 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Sand Play Therapy (Behavioral)

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.

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ondokuz Mayıs University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gözde GÜNDÜZ

Doctor of Philosophy Registered Nurse

Ondokuz Mayıs University

Study Sites (1)

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