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

NCT ID: NCT06846944

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2025-03-31

Brief Summary

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.

Conditions

Surgeries Requiring a Minimum One Day Hospitalization; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Breathing/relaxation intervention

Intervention Type: OTHER

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.

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meyer Children's Hospital IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Gabriella Barresi

Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Meyer Children's Hospital IRCCS, Firenze

Florence, Fi, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gabriella Barresi, Nurse

Role: CONTACT

gabriella.barresi@meyer.it

+390555662744

Facility Contacts

Gabriella Barresi

Role: primary

gabriella.barresi@meyer.it

+390555662744

Other Identifiers

LADYBUG

Identifier Type: -

Identifier Source: org_study_id