NCT07413289

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

February 2, 2026

Last Update Submit

March 22, 2026

Conditions

Keywords

delirium

Outcome Measures

Primary Outcomes (1)

  • 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.

    about a month and a half

Secondary Outcomes (1)

  • The mother's current and sustained anxiety levels.

    1 and a half months

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients who will undergo adenotonsillectomy surgery in the ENT operating room in 1.5 months.

You may qualify if:

  • Pediatric patients who will undergo adenotonsillectomy surgery

You may not qualify if:

  • children whose mother or child has hearing or speech impairments and chronic/genetic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mardin Artuklu University Training and Research Hospital

Mardin, Artuklu, 47100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 37844877BACKGROUND

MeSH Terms

Conditions

Emergence DeliriumDelirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • enes ç çelik, MD

    Mardin Artuklu University Medicine School

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 17, 2026

Study Start

February 1, 2026

Primary Completion

March 20, 2026

Study Completion

March 22, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations