ClinicalTrials.gg
CompletedNCT07902674Updated Oct 29, 2026

the Effect of the Preoperative Information Method on Intraoperative Anxiety and Postoperative Outcomes in AIS Patients: a Randomized Clinical Trial

An interventional study of İntervention 1: Video-Based Preoperative Education and İntervention 2: Brochure-Based Preoperative Education in Adolescence Idiopathic Scoliosis, Preoperative Anxiety and Postoperative Pain After Spinal Surgery, sponsored by Gazi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Gazi University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Jun 2024, registered Oct 2026).
Updated Oct 29, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,095 studies in Pain, Postoperative with a site in Turkey — 264 open to participants now, 296 under way, none of them phase 3. Pain, Postoperative · Turkey.

Enrollment
787th of 880
42 · median 70
Started
2024
with 150 others
No phase
811 of 1,095
217 open now
Registered
1,084th of 1,095
by date

Among the 1,095 studies in Pain, Postoperative with a site in Turkey, this one is the 787th largest by enrollment of the 880 interventional ones that give a count, is one of 151 that started in 2024, is one of 811 with no phase, and was the 1,084th registered.

Pain, Postoperative

5,648 studies on the registry are indexed under Pain, Postoperative; 1,231 are open to participants now.

Browse Pain, Postoperative studies →

Open to participants now

264 of the 1,095 studies in Pain, Postoperative with a site in Turkey are open now. Recruiting first, the newest first:

259 more — sign in →

All 264 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 679 Pain, Postoperative studies recruiting now, 240 (35%) set no upper age limit and 329 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.

This study: 10 Years to 18 Years · all sexes · no healthy volunteers.

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02

Study summary

Due to the increasing use of smartphones and social media in contemporary times, adolescents experience a rapid loss of attention while reading or listening. Educational videos available on the internet are now more frequently utilized as a means of accessing information. The aim of our study is to evaluate the impact of educational videos, educational brochures, and routine verbal counseling on preoperative anxiety and postoperative outcome.

Read the detailed description

This is a prospective, single-center, three-arm, parallel-group randomized controlled trial conducted at Gazi University evaluating whether the modality of preoperative patient education influences perioperative anxiety and postoperative patient-reported outcomes in adolescents undergoing posterior spinal fusion (PSF) for adolescent idiopathic scoliosis (AIS).

Preoperative anxiety is a common and potentially modifiable contributor to postoperative pain and functional recovery in AIS patients, and the level of anxiety experienced has been linked to the amount and format of information provided before surgery. Because adolescents today increasingly engage with audiovisual content rather than printed text, this trial was designed to compare an animated educational video against a content-matched printed brochure and against routine verbal counseling (control), in order to determine whether the format of preoperative education modifies its effect on anxiety and postoperative outcomes.

After providing written informed consent, participants underwent baseline assessment approximately 3 days before surgery. They were then randomly allocated in a 1:1:1 ratio to one of three preoperative education arms: (1) an animated educational video produced using a commercial cloud-based animation platform, (2) a printed brochure containing text identical to the video narration, or (3) routine verbal counseling delivered by the clinical team. The randomization sequence was generated using an external web-based randomization tool. Allocation concealment was maintained by withholding the sequence from the treating physician and surgeon; a separate study team member communicated the assigned intervention to the researcher who delivered the education session, after the participant's informed consent was obtained.

On the morning of surgery, state anxiety was reassessed to capture the acute perioperative response to the assigned education method. Baseline outcome instruments were re-administered at 3 months postoperatively to assess the persistence of any intervention effect into the recovery period.

Between- and within-group comparisons were conducted using non-parametric methods appropriate to the distribution of the outcome data, supplemented by regression modeling to evaluate the effect of education modality on outcome changes while adjusting for participant age. Full statistical methods are reported in the associated manuscript and are not duplicated here.

03

Conditions studied

  • Adolescence Idiopathic Scoliosis
  • Preoperative Anxiety
  • Postoperative Pain After Spinal Surgery

Keywords

  • posterior spinal fusion
  • Preoperative patient education
  • perioperative anxiety
  • Patient-Reported Outcomes
  • Educational video
04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age between 10 and 18 years Diagnosis of Adolescent Idiopathic Scoliosis (AIS) Scheduled to undergo posterior spinal fusion surgery Provision of written by the patient and/or legal guardian

Exclusion criteria

Exclusion Criteria:

Inability of the patient or family to read or write Presence of an additional (comorbid) psychiatric disorder Unwillingness to participate in the randomized study

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Video Education

    Behavioral: İntervention 1: Video-Based Preoperative Education

  • Experimental
    Brochure Education

    Behavioral: İntervention 2: Brochure-Based Preoperative Education

  • Active comparator
    Verbal counselling (Control)

    Behavioral: Routine Verbal Preoperative Counseling

Interventions

  • Behavioralİntervention 1: Video-Based Preoperative Education

    A short animation explaining the preoperative, intraoperative, and postoperative phases in simple language

  • Behavioralİntervention 2: Brochure-Based Preoperative Education

    A brochure explaining the preoperative, intraoperative, and postoperative phases in simple language

  • BehavioralRoutine Verbal Preoperative Counseling

    Routine verbal preoperative counselling for surgery process

06

What researchers measure

Primary outcomes

  1. Change in Perioperative (State) Anxiety Level, assessed by the State-Trait Anxiety Inventory (STAI)

    State anxiety was measured using the STAI three days before surgery and again on the morning of surgery, and compared among the three preoperative education groups (video, brochure, routine verbal counseling).

    Time frame: From baseline (3 days before surgery) to the morning of surgery

  2. Change in Scoliosis Research Society-22 (SRS-22) postoperative outcome scores

    Pain domain score of the SRS-22 questionnaire, compared among the three preoperative education groups at the 3-month postoperative follow-up.

    Time frame: From baseline (preoperative) to 3 months postoperatively

07

Study locations

1 site
  • Gazi University
    Ankara, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared because the informed consent obtained from participants and their legal guardians did not include provisions for sharing de-identified data beyond the scope of this study. Additionally, given the small, single-center cohort (n=42) and the pediatric nature of the study population, there is an elevated risk of participant re-identification even after standard de-identification procedures.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2024 to primary completion in Sep 2024, 3 months.

Of 2,096 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 3 months is below that.

Counting every sponsor, half of 2,109 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2026
First posted
Oct 29, 2026
StartActual
Jun 1, 2024
Primary completionActual
Sep 1, 2024
CompletionActual
Dec 1, 2024
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07902674
Lead sponsor
Gazi University
Responsible party
Alim Can BAYMURAT (M.D, Gazi University) — Principal investigator
First posted
Oct 29, 2026
Start date
Jun 1, 2024
Primary completion
Sep 1, 2024
Completion
Dec 1, 2024
Last update
Oct 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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