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

NCT06579586 | Completed

• 1 other identifier: SumeyraDoluoglu1
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parents; Anxiety; Complication of Surgical Procedure; Pain

Keywords

Parental anxiety; Tonsillectomy; Postoperative pain; Complication of tonsillectomy

Outcome Measures

Primary Outcomes (4)

• Evaluation the relationship between parents' anxiety level in the preoperative period and pain perception and complications in children undergoing tonsillectomy ± adenoidectomy

  Pain perception in parents with high anxiety level and in children of these parents who underwent an operation such as adenotonsillectomy that may cause intense pain sensation was questioned by the parent and then by the child at postoperative 6th hour, 24th hour, 1st week and 2nd week.

  14 days

• Determination of preoperative anxiety level in parents of children undergoing tonsillectomy +/- adenoidectomy with State-Trait Anxiety Inventory

  It is a scale consisting of two stages as state and trait anxiety levels. It consists of 40 questions in total, 20 questions each. State anxiety is used to define the level of anxiety in a particular situation, whereas trait anxiety is used to define the anxiety experienced independently of the situation the person is in. Each question is evaluated on a scale of at least 1 (never) and at most 4 points (always) and is expressed in scores ranging from 20-80 points. High scores indicate high levels of anxiety.

  21 days

• Determination of preoperative anxiety level in parents of children undergoing tonsillectomy +/- adenoidectomy with Anxiety Sensitivity Index-3

  Anxiety sensitivity (AS) is characterised as 'an excessive fear of anxiety-related sensations and symptoms that are believed to have harmful physical and/or social consequences'. People with high AS tend to misinterpret sudden, relatively severe and unexplained physical symptoms of anxiety as dangerous, but often tend to avoid them. While '0' means very little, '4' means very much. The score that can be obtained from the scale is between 0-72. The practitioners are asked to indicate to what extent they agree with the statements in each item by taking into account their previous experiences related to the statements in each item, or if they have no experience with that item, they are asked to indicate how they would feel if they experienced that situation. There are no reverse items in the scale. A high score indicates high anxiety sensitivity.

  21 days

• Determination of preoperative anxiety level in parents of children undergoing tonsillectomy +/- adenoidectomy with Pain Catastrophising Scale for Parents

  Pain catastrophising is the tendency to over-focus on and exaggerate the response to painful stimuli and their threat value, and to feel more helpless about the pain experience. It was developed because of the need to relate the degree to which parents catastrophise their children's suffering and the effects on their children's well-being and behaviour. It is assessed with a 5-point scale ranging from 0 (not at all) to 4 (very much). Items from the subscales are added to obtain a total score between 0 and 52; higher scores reflect higher levels of catastrophic thinking in parents.

  21 days

Study Arms (1)

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.

Behavioral: Survey study

Interventions

Survey study 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.

Children undergoing tonsillectomy ± adenoidectomy

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 4-15 years, who had no history of psychiatric-mental illness or drug use in themselves or their parents, and who underwent tonsillectomy + adenoidectomy for chronic tonsillitis or sleep-disordered breathing were included in the study.

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Sumeyra DOLUOGLU: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40323129 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Pain; Pain, Postoperative

Interventions

Longitudinal Studies

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sumeyra Doluoglu, MD

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 30, 2024
• Study Start: August 20, 2024
• Primary Completion: November 20, 2024
• Study Completion: November 25, 2024
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

TU (1)