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NCT Number: NCT06846944

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.

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Key information

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meyer Children's Hospital IRCCS, Firenze

Florence, Fi, 50134, Italy

Location status: Recruiting

Location contact

Gabriella Barresi

CONTACT

[email protected]

+390555662744

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Breathing/relaxation intervention

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.

Primary outcomes

  1. Percentage reduction in anxiety score

    Time frame: From recruitment to end of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriella Barresi, Nurse

CONTACT

[email protected]

+390555662744

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2025
Registry last updated
Feb 26, 2025

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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