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Completed

NCT Number: NCT06634680

Effects of Different Parental Involvement on Anxiety and Delirium

Induction of anesthesia in surgical procedures can be a distressing process for both children and their parents. Nonpharmacological behavioral interventions, unlike sedative medications, can reduce children's anxiety without adverse effects. The effect of having both parents present during anesthesia induction on children's anxiety and parents' anxiety has not yet been documented.

This study will aim to evaluate the effect of having both parents present during anesthesia induction on children's 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

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rafet YARIMOGLU

Karaman, 70200, Turkey (Türkiye)

About this study

Surgery can be very stressful for patients, especially children. Studies show that 50-75% of children experience fear and anxiety when undergoing surgery and being put under anesthesia. This anxiety can have adverse effects on their recovery, leading to more extended hospital stays, increased pain, and behavioral issues. To address this, various medical and non-medical approaches are used to ease children's fears. One such approach is allowing parents to be with their children until the anesthesia takes effect. This study aims to assess how having both parents present during this time impacts the child's anxiety levels.

The effect of parental presence on the anxiety of children and parents was studied in various studies. Whether both parents affect anxiety has not been studied yet. In this study the investigators 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 5-12 years with ASA physical Status I-II will be enrolled

Exclusion criteria

  • Mentally challenged
  • Deaf Child
  • Cerebral Palsy
  • Premedicated Child
  • Language Problem
  • Uncooperative
  • History of psychiatric disease in children or the parents
  • Previous surgery or anesthesia history

Treatment and study plan

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

Procedure

Children will choose the parent who will accompany them.

Procedure: Both parents will accompany the children.

Procedure

Both parents will accompany the children.

Primary outcomes

  1. Patients anxiety-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 23.3 to 100, with higher scores indicating greater anxiety.

Secondary outcomes

  1. Emergence delirium-Pediatric Anesthesia Emergence Delirium Scale (PAEDS)

    Time frame: Perioperative period

    Pediatric Anaesthesia Emergence Delirium (PAED) scale consists of 5 criteria (eye contact, purposeful movement, awareness of environment, restlessness, inconsolability) that are scored using a 5-point scale. The scores of each criterion are added to make a total score. The score changes 0-20. Scores above 10 indicate delirium, while scores below 10 indicate no delirium.

  2. Parent anxiety-STAI

    Time frame: Perioperative period

    The State-Trait Anxiety Inventory (STAI) was used to evaluate the anxiety level of the parents. The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

Effects of Different Parental Involvement on Anxiety and Delirium in Children Undergoing Elective ENT Surgery

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 10, 2024
Registry last updated
Dec 16, 2024

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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