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OpenTrials
Completed

NCT Number: NCT03314220

The Effectiveness of Preoperative Preparation for Improving Perioperative Outcomes in Children and Caregivers

This study aimed to accomplish the following objectives:

1. Develop a family-centered preoperative preparation program. 2. Evaluate the effectiveness of this program in terms of children's preoperative emotional behaviors, postoperative behavior, and posthospital behavior and caregivers' anxiety.

Completed

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Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • aged 3-12 years, received general anesthesia, and admitted for elective outpatient ear, nose and throat, orthopedic, ophthalmology or general surgery.

Exclusion criteria

  • Children with severe development delay or chronic illness were excluded. Caregivers were excluded if they could not accompany their child to the hospital on the day of the surgery.

Treatment and study plan

preoperative preparation

Behavioral

Participants in the experimental group received standard care plus our newly developed, multicomponent family-centered preoperative preparation program. This program included the following: (1) a tour of the preoperative area and recovery room; (2) a 4-min cartoon video entitled 'I am not afraid of surgery,' which was tailored to the child; this video included 29 scenes that depicted a boy's surgical journey with a particular emphasis on strategies for addressing postoperative pain; and (3) familiarization with medical equipment such as name badges, disposable hair caps, anesthetic masks, EKG leads, and pulse oximeters, which were placed on a doll, to help children understand the surgical instruments and promote better cooperation at the time of anesthesia induction.

Primary outcomes

  1. Children's Emotional Behaviors: The Children's Emotional Manifestation Scale

    Time frame: before the operative day

    to assess children's emotional behaviors during stressful medical situations

  2. Children's Emotional Behaviors: The Children's Emotional Manifestation Scale

    Time frame: the morning in the day of surgery

    to assess children's emotional behaviors during stressful medical situations

  3. Children's Emotional Behaviors: The Children's Emotional Manifestation Scale

    Time frame: at induction of anesthesia

    to assess children's emotional behaviors during stressful medical situations

Sponsors and collaborators

Lead sponsor

Chiayi Christian Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2017
Registry last updated
Oct 19, 2017

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.