Effect of Child Preference for Parental Selection During Induction

Induction of anesthesia can be distressing both for children and their parents. Nonpharmacological behavioral interventions can reduce the anxiety of children without significant adverse effects as seen with sedative drugs. has not been documented.

The aim of this study will be to evaluate the effect of children's preference on parental selection during the induction of anesthesia on children and parental anxiety during the perioperative period.

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Key information

Conditions

Anxiety State Anxiety Disorders Behavior Child Behavior Mental Disorders

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

About this study

Anesthetic induction can be one of the most stressful experiences for the child during the perioperative period, with almost 50% of the children showing significant anxiety. . To minimize the effect of anxiety, several methods have been adopted, such as the introduction of day-case surgery, parental presence at the induction of anesthesia, distractions and the use of pharmacological agents like midazolam to reduce anxiety.

Although the effect of parental presence on the anxiety of children and parents was studied in various studies. Whether the children's choice of parental selection affects anxiety is not studied yet. In this study, we will evaluate the anxiety of children by using mYPAS .

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

80 children of both sex, aged 4-15 years with ASA physical Status I-II will be enrolled

Exclusion criteria

Mentally challenged
Deaf Child
Cerebral Palsy
Premedicated Child
Language Problem
Unco-operative
Previous surgery or anesthesia history

Treatment and study plan

Selection of parent(mother or father) according to children preference

Procedure

The parent who will accompany the child during the perioperative period will be determined by children preference

Selection of parent(mother or father) according to randomization

Procedure

The parent who will accompany the child during the perioperative period will be determined by randomization.

Primary outcomes

Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia.

Time frame: Perioperative period

The mYPAS will be used to evaluate the anxiety level of children. The mYPAS is an observational measure of preoperative anxiety consisting of 27 items in 5 domains (activity, emotional expressivity, state of arousal, vocalization, and use of parents). The adjusted mYPAS total score ranges from 22.9 to 100, with higher scores indicating greater anxiety.

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

Effect of Child Preference for Parental Selection During Induction in Children Undergoing Elective Day Case Surgery

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Dec 12, 2022
Registry last updated: Feb 15, 2023

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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Completed