Mixed-method Research Protocol: Evaluation of a Relaxation Technique for Anxiety Management in Pre-surgical Pediatric Patients

Children exhibit anxiety before surgery: in particular, the literature reports that younger children have a higher level of preoperative anxiety than older children. Preoperative anxiety has been associated with side effects such as postoperative pain and emergence delirium (ED), which are generally treated with the administration of analgesics but can cause nausea, vomiting, and drowsiness.

In addition to pharmacological strategies, there are behavioral and psychological techniques commonly referred to as nonpharmacological techniques to reduce preoperative anxiety. These are a broad set of strategies and methods, more or less complex, that can be applied to children and adolescents to help them cope with preoperative agitation and for pain control.

Nonpharmacological techniques include distraction techniques that have shown promise in reducing pediatric anxiety and include listening to music , the use of humor, and the use of games . Several researchers have found active distraction to be an effective preoperative anxiolytic in children. Of relevant importance for reducing preoperative anxiety are relaxation techniques as shown in the literature and in particular by a randomized trial that demonstrated the effectiveness of this type of proposed nonpharmacological technique for reducing anxiety and pain in pediatric patients in a preoperative setting.

This study plan to investigate the effectiveness of a breathing/relaxation intervention (Ladybug/Sunshine method) on pediatric patients' anxiety levels before surgery.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Surgeries Requiring a Minimum One Day Hospitalization
• Intervention / Treatment: Other: Breathing/relaxation intervention

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriella Barresi, Nurse; Phone Number: +390555662744; Email: gabriella.barresi@meyer.it

Study Locations

• Italy
  • Fi
    • Firenze, Fi, Italy, 50134
      • Recruiting
      • Meyer Children's Hospital IRCCS, Firenze
      • Contact: Gabriella Barresi; Phone Number: +390555662744; Email: gabriella.barresi@meyer.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 5 years and 15 years;
• Admission for minor surgical conditions of low intensity, such as inguinal hernia, phimosis, sebaceous cysts, vascular malformations, skin lesions, ankyloglossus, afferent to the unified pediatric surgery day-surgery service of AOU Meyer;
• Knowledge of the Italian language and ability to express oneself;

Exclusion Criteria:

• Presence of cognitive impairment reported in history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care
Experimental: Ladybug and Sunrise breathing/relaxation technique; Ladybug TECHNIQUE is a breathing/relaxation intervention performed in children aged 5 to 10 years and consists of telling the story of a ladybug performing 4 moves and visualizing and performing breathing techniques independently. Afterwards, a drawing is invited. SUNRISE TECHNIQUE is a breathing/relaxation intervention performed in children aged 10 to 15 years and consists of having the child imagine a favorite place. Then they are invited to reflect on the experience either verbally or through writing or drawing.	Other: Breathing/relaxation intervention; Ladybug TECHNIQUE is a breathing/relaxation intervention performed in children aged 5 to 10 years and consists of telling the story of a ladybug performing 4 moves and visualizing and performing breathing techniques independently. Afterwards, a drawing is invited. SUNRISE TECHNIQUE is a breathing/relaxation intervention performed in children aged 10 to 15 years and consists of having the child imagine a favorite place. Then they are invited to reflect on the experience either verbally or through writing or drawing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage reduction in anxiety score	From recruitment to end of surgery

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: LADYBUG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No