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Effects of Different Parental Involvement on Anxiety and Delirium

NCT ID: NCT06634680

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-15

Study Completion Date

2024-12-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anxiety State Child Behavior

Keywords

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anxiety children anesthesia,general

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group Child Preference

The children will prefer parents (mother or father) who will accompany them in the preoperative holding area and at induction.

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

Intervention Type PROCEDURE

Children will choose the parent who will accompany them.

Group Both Parents

Both parents will accompany the child in the preoperative holding area and at induction.

Procedure: Both parents will accompany the children.

Intervention Type PROCEDURE

Both parents will accompany the children.

Interventions

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

Children will choose the parent who will accompany them.

Intervention Type PROCEDURE

Procedure: Both parents will accompany the children.

Both parents will accompany the children.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karaman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rafet YARIMOGLU

Role: PRINCIPAL_INVESTIGATOR

Karaman Training and Research Hospital

Locations

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Rafet YARIMOGLU

Karaman, Karaman, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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04- 2024/15

Identifier Type: -

Identifier Source: org_study_id