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

The Relationship Between Parental Anxiety and Postoperative Pain and Complications in 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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety; Parents; Complication of Surgical Procedure
• Intervention / Treatment: Behavioral: Survey study

• Study Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06010
    • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sumeyra DOLUOGLU
• Investigators: Principal Investigator: Sumeyra Doluoglu, MD, Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Actual): November 20, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Tonsillectomy; Postoperative pain; Parental anxiety; Complication of tonsillectomy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Anxiety Disorders
• Other Study ID Numbers: SumeyraDoluoglu1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No