Parental Anxiety and Postoperative Pain and Complications in Children Undergoing Tonsillectomy ± Adenoidectomy

NCT ID: NCT06579586

Last Updated: 2025-04-11

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

145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-20

Study Completion Date

2024-11-25

Brief Summary

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It is aimed to understand whether high parental anxiety leads to increased pain in children undergoing tonsillectomy ± adenoidectomy surgery and whether it increases the development of complications.

Detailed Description

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Conditions

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Parents Anxiety Complication of Surgical Procedure Pain

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

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Children undergoing tonsillectomy ± adenoidectomy

It is aimed to understand whether high parental anxiety leads to increased pain in children undergoing tonsillectomy ± adenoidectomy surgery and whether it increases the development of complications.

Survey study

Intervention Type BEHAVIORAL

The Parent's State and Trait Anxiety Inventory (STAI), Anxiety Sensitivity Index-3 (AS-3), and Pain Catastrophising Scale for Parents (PPS-PPS) were completed one day before the operation to measure anxiety level.

Interventions

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Survey study

The Parent's State and Trait Anxiety Inventory (STAI), Anxiety Sensitivity Index-3 (AS-3), and Pain Catastrophising Scale for Parents (PPS-PPS) were completed one day before the operation to measure anxiety level.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 4-15 years old child patient
* Willingness to participate in the study by the patient and/or parent
* No history of psychiatric-mental illness or drug use in the patient and/or parents
* The patient has no craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
* No bleeding disorder or disease

Exclusion Criteria

* \<4 years old, \>15 years old paediatric patients
* Not wanting to participate in the study at any stage of the study
* History of psychiatric-mental illness or drug use in the patient and parents
* The patient has craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
* Having a bleeding disorder or disease
Minimum Eligible Age

4 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sumeyra DOLUOGLU

OTHER

Sponsor Role lead

Responsible Party

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Sumeyra DOLUOGLU

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sumeyra Doluoglu, MD

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

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Ankara Etlik City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Doluoglu S, Gazeloglu AZ, Kocyigit Y, Vural Camalan B, Ozlugedik S. Effects of Parental Anxiety on the Postoperative Pain and Complications of Children Undergoing Adenotonsillectomy. Laryngoscope. 2025 Sep;135(9):3422-3429. doi: 10.1002/lary.32217. Epub 2025 May 5.

Reference Type DERIVED
PMID: 40323129 (View on PubMed)

Other Identifiers

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SumeyraDoluoglu1

Identifier Type: -

Identifier Source: org_study_id

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