Delirium - PostoperativeDeliriumNCT07413289
Pediatric Recovery Delirium in Pediatric Patients Undergoing Surgery
An observational study of Delirium - Postoperative and Anxiety Acute, run by Enes Celik at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this observational study is to evaluate the effect of playing a mother's voice to a child while the patient is being awakened from anesthesia on postoperative delirium. For this purpose, a recording of the mother's voice will be prepared before surgery. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Delirium - Postoperative, Anxiety Acute
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 22 Mar 2026
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pediatric patients who will undergo adenotonsillectomy surgery in the ENT operating room in 1.5 months.
Who may be able to join
- Pediatric patients who will undergo adenotonsillectomy surgery
Who cannot join
- children whose mother or child has hearing or speech impairments and chronic/genetic diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mardin Artuklu University Training and Research Hospital
Mardin, Artuklu, 47100
About this study
Official title: The Effect Of Recorded Maternal Voice On Pediatric Recovery Delirium In Pediatric Patients Undergoing Adenotonsillectomy Surgery
The primary aim of this observational study is to evaluate the effect of playing a mother's voice to a child while the patient is being awakened from anesthesia on postoperative delirium. For this purpose, a recording of the mother's voice will be prepared before surgery. In this recording, the mother will reassure the child that they are safe and encourage them to remain calm. This recording will then be played to the patient during the awakening phase from anesthesia. The frequency of postoperative delirium in participants who were awakened by the voice recording will be compared with that of the patient group who were awakened without the voice recording.
Read the detailed description
In this study, mothers' anxiety levels will be measured and recorded using the STAI 1 and 2 questionnaires. Children's postoperative anxiety will be recorded using the modified Yale questionnaire and the PAED. Additionally, the FLACC scale will be used to record information in postoperative children.
- Conditions
- Delirium - Postoperative, Anxiety Acute
- Keywords
- delirium
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients listening to their mother's voice | The mother's voice will be recorded beforehand using a voice recorder, and this recording will be played when the child is awakened from anesthesia. | |
| patients who have not heard their mother's voice | The other children were not played the mother's voice recording. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative delirium
The primary aim of this study is to evaluate the effect of playing a mother's voice to a child while the patient is being awakened from anesthesia on postoperative delirium. To assess this effect, participants will be administered the Modified Yale Preoperative Anxiety Scale, and in the postoperative period, the PAED and FLACC scales will also be applied.
Measured: about a month and a half
Secondary outcomes (1)
The mother's current and sustained anxiety levels.
The mother will be asked to complete STAI TX 1 and STAI TX 2 forms, respectively, to assess her anxiety levels in both her immediate and normal daily life. The aim is to evaluate the relationship between the mother's anxiety level and the patient's frequency of delirium.
Measured: 1 and a half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Feb 2026
- Primary completion20 Mar 2026
- Study completion22 Mar 2026
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 Delirium - PostoperativeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Enes Celik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enes Celik, Mardin Artuklu University
- Investigators
- enes ç çelik, MD, Study director, Mardin Artuklu University Medicine School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413289
- Sponsor's protocol ID
- 18.02.2025-2025/2-5
- Acronym
- Delirium
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cao X, Wang B, Liu M, Li J. Effect of recorded mother's voice on emergence delirium in pediatric patients: a systematic review with meta-analysis. J Pediatr (Rio J). 2024 May-Jun;100(3):231-241. doi: 10.1016/j.jped.2023.08.008. Epub 2023 Oct 14.
PubMed 37844877
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Recorded Maternal Voice On Pediatric Recovery Delirium In Pediatric Patients Undergoing Adenotonsillectomy Surgery
- ClinicalTrials.gov ID
- NCT07413289
- Acronym / sponsor ID
- Delirium / 18.02.2025-2025/2-5
- Conditions
- Delirium - Postoperative, Anxiety Acute
- Keywords
- delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Enes CelikUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 22 Mar 2026 (actual)
- First posted
- 17 Feb 2026 (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.
The primary aim of this observational study is to evaluate the effect of playing a mother's voice to a child while the patient is being awakened from anesthesia on postoperative delirium. For this purpose, a recording of the mother's voice will be prepared before surgery. In this recording, the mother will reassure the child that they are safe and encourage them to remain calm. This recording will then be played to the patient during the awakening phase from anesthesia. The frequency of postoperative delirium in participants who were awakened by the voice recording will be compared with that of the patient group who were awakened without the voice recording.
Detailed description
In this study, mothers' anxiety levels will be measured and recorded using the STAI 1 and 2 questionnaires. Children's postoperative anxiety will be recorded using the modified Yale questionnaire and the PAED. Additionally, the FLACC scale will be used to record information in postoperative children.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients listening to their mother's voice | – | –The mother's voice will be recorded beforehand using a voice recorder, and this recording will be played when the child is awakened from anesthesia. |
| patients who have not heard their mother's voice | – | –The other children were not played the mother's voice recording. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric patients who will undergo adenotonsillectomy surgery in the ENT operating room in 1.5 months.
Key inclusion criteria (1 listed)
- Pediatric patients who will undergo adenotonsillectomy surgery
Key exclusion criteria (1 listed)
- children whose mother or child has hearing or speech impairments and chronic/genetic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative delirium
Time frame: about a month and a half
The primary aim of this study is to evaluate the effect of playing a mother's voice to a child while the patient is being awakened from anesthesia on postoperative delirium. To assess this effect, participants will be administered the Modified Yale Preoperative Anxiety Scale, and in the postoperative period, the PAED and FLACC scales will also be applied.
1 secondary outcome
The mother's current and sustained anxiety levels.
Time frame: 1 and a half months
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 25 Mar 2026.
- Background: PubMed 37844877Cao X, Wang B, Liu M, Li J. Effect of recorded mother's voice on emergence delirium in pediatric patients: a systematic review with meta-analysis. J Pediatr (Rio J). 2024 May-Jun;100(3):231-241. doi: 10.1016/j.jped.2023.08.008. Epub 2023 Oct 14.
- Individual participant dataSharing planned: No
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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.
enes ç çelik, MD study director
Mardin Artuklu University Medicine School
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 Delirium - Postoperative and Anxiety Acute, run by Enes Celik 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 1 inclusion and 1 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 25 Mar 2026. 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?
postoperative delirium (time frame: about a month and a half). 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 NCT07413289, 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 25 Mar 2026.