ParentsNCT06579586
Parental Anxiety and Postoperative Pain and Complications in Children Undergoing Tonsillectomy ± Adenoidectomy
An observational study of Parents and Anxiety, run by Sumeyra DOLUOGLU at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Parents, Anxiety, Complication of Surgical Procedure
- What is being tested?
- Survey study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 145 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2024to 25 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Parents, Anxiety, Complication of Surgical Procedure, Pain
- Being tested
- Survey study
- Keywords
- Parental anxiety, Tonsillectomy, Postoperative pain, Complication of tonsillectomy
- Medical subject headings
- Anxiety Disorders, Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey studyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Survey study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start20 Aug 2024
- Primary completion20 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumeyra DOLUOGLU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sumeyra DOLUOGLU, Saglik Bilimleri Universitesi
- Investigators
- Sumeyra Doluoglu, MD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579586
- Sponsor's protocol ID
- SumeyraDoluoglu1
- Status last verified
- Apr 2025
- First submitted
- 21 Aug 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40323129
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Parental Anxiety and Postoperative Pain and Complications in Children Undergoing Tonsillectomy ± Adenoidectomy
- ClinicalTrials.gov ID
- NCT06579586
- Acronym / sponsor ID
- SumeyraDoluoglu1
- Conditions
- Parents, Anxiety, Complication of Surgical Procedure, Pain
- Keywords
- Parental anxiety, Tonsillectomy, Postoperative pain, Complication of tonsillectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Sumeyra DOLUOGLUUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children undergoing tonsillectomy ± adenoidectomy | – | Behavioral: Survey studyIt 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. |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey studyThe 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. | Behavioural | Children undergoing tonsillectomy ± adenoidectomy |
Primary outcome
Evaluation the relationship between parents' anxiety level in the preoperative period and pain perception and complications in children undergoing tonsillectomy ± adenoidectomy
Time frame: 14 days
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.
Determination of preoperative anxiety level in parents of children undergoing tonsillectomy +/- adenoidectomy with State-Trait Anxiety Inventory
Time frame: 21 days
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.
Determination of preoperative anxiety level in parents of children undergoing tonsillectomy +/- adenoidectomy with Anxiety Sensitivity Index-3
Time frame: 21 days
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.
Determination of preoperative anxiety level in parents of children undergoing tonsillectomy +/- adenoidectomy with Pain Catastrophising Scale for Parents
Time frame: 21 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 40323129Doluoglu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumeyra Doluoglu, MD principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parents and Anxiety, run by Sumeyra DOLUOGLU at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the relationship between parents' anxiety level in the preoperative period and pain perception and complications in children undergoing tonsillectomy ± adenoidectomy (time frame: 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06579586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.