Adolescence Idiopathic ScoliosisNCT07902674
the Effect of the Preoperative Information Method on Intraoperative Anxiety and Postoperative Outcomes in AIS Patients: a Randomized Clinical Trial
A study testing İntervention 1: Video-Based Preoperative Education, İntervention 2: Brochure-Based Preoperative Education and Routine Verbal Preoperative Counseling in people with Adolescence Idiopathic Scoliosis and Preoperative Anxiety, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescence Idiopathic Scoliosis, Preoperative Anxiety, Postoperative Pain After Spinal Surgery
- What is being tested?
- İntervention 1: Video-Based Preoperative Education, İntervention 2: Brochure-Based Preoperative Education and Routine Verbal Preoperative Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Dec 2024
- Phase
- Interventional
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 10 and 18 years Diagnosis of Adolescent Idiopathic Scoliosis (AIS) Scheduled to undergo posterior spinal fusion surgery Provision of written informed consent by the patient and/or legal guardian
Who cannot join
- Inability of the patient or family to read or write Presence of an additional (comorbid) psychiatric disorder Unwillingness to participate in the randomized study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARİSON OF THE EFFECTS OF PREOPERATİVE EDUCATİON ON ANXİETY, STRESS COPİNG LEVELS, SELF-ESTEEM, AND PAİN CATASTROPHİZİNG
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.
- Conditions
- Adolescence Idiopathic Scoliosis, Preoperative Anxiety, Postoperative Pain After Spinal Surgery
- Being tested
- İntervention 1: Video-Based Preoperative Education, İntervention 2: Brochure-Based Preoperative Education, Routine Verbal Preoperative Counseling
- Keywords
- posterior spinal fusion, Preoperative patient education, perioperative anxiety, Patient-Reported Outcomes, Educational video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İntervention 1: Video-Based Preoperative EducationBehavioural
A short animation explaining the preoperative, intraoperative, and postoperative phases in simple language
İntervention 2: Brochure-Based Preoperative EducationBehavioural
A brochure explaining the preoperative, intraoperative, and postoperative phases in simple language
Routine Verbal Preoperative CounselingBehavioural
Routine verbal preoperative counselling for surgery process
| Study group | Role | What they receive |
|---|---|---|
| Video Education | Experimental | Not described Receives: Behavioral: İntervention 1: Video-Based Preoperative Education |
| Brochure Education | Experimental | Not described Receives: Behavioral: İntervention 2: Brochure-Based Preoperative Education |
| Verbal counselling (Control) | Active comparator | Not described Receives: Behavioral: Routine Verbal Preoperative Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline (3 days before surgery) to the morning of surgery
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.
Measured: From baseline (preoperative) to 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Jun 2024
- Primary completion1 Sep 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescence Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alim Can BAYMURAT, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902674
- Sponsor's protocol ID
- 2024-911
- Other IDs
- E.975437
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARİSON OF THE EFFECTS OF PREOPERATİVE EDUCATİON ON ANXİETY, STRESS COPİNG LEVELS, SELF-ESTEEM, AND PAİN CATASTROPHİZİNG
- ClinicalTrials.gov ID
- NCT07902674
- Acronym / sponsor ID
- 2024-911
- Conditions
- Adolescence Idiopathic Scoliosis, Preoperative Anxiety, Postoperative Pain After Spinal Surgery
- Keywords
- posterior spinal fusion, Preoperative patient education, perioperative anxiety, Patient-Reported Outcomes, Educational video
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 29 Oct 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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Video Education | Experimental | Behavioral: İntervention 1: Video-Based Preoperative Education |
| Brochure Education | Experimental | Behavioral: İntervention 2: Brochure-Based Preoperative Education |
| Verbal counselling (Control) | Active comparator | Behavioral: Routine Verbal Preoperative Counseling |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Age between 10 and 18 years Diagnosis of Adolescent Idiopathic Scoliosis (AIS) Scheduled to undergo posterior spinal fusion surgery Provision of written informed consent by the patient and/or legal guardian
Key exclusion criteria (1 listed)
- Inability of the patient or family to read or write Presence of an additional (comorbid) psychiatric disorder Unwillingness to participate in the randomized study
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 |
|---|---|---|
| İntervention 1: Video-Based Preoperative EducationA short animation explaining the preoperative, intraoperative, and postoperative phases in simple language | Behavioural | Video Education |
| İntervention 2: Brochure-Based Preoperative EducationA brochure explaining the preoperative, intraoperative, and postoperative phases in simple language | Behavioural | Brochure Education |
| Routine Verbal Preoperative CounselingRoutine verbal preoperative counselling for surgery process | Behavioural | Verbal counselling (Control) |
Primary outcome
Change in Perioperative (State) Anxiety Level, assessed by the State-Trait Anxiety Inventory (STAI)
Time frame: From baseline (3 days before surgery) to the morning of surgery
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).
Change in Scoliosis Research Society-22 (SRS-22) postoperative outcome scores
Time frame: From baseline (preoperative) to 3 months postoperatively
Pain domain score of the SRS-22 questionnaire, compared among the three preoperative education groups at the 3-month postoperative follow-up.
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 29 Oct 2026.
- Individual participant dataSharing planned: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing İntervention 1: Video-Based Preoperative Education, İntervention 2: Brochure-Based Preoperative Education and Routine Verbal Preoperative Counseling in people with Adolescence Idiopathic Scoliosis and Preoperative Anxiety, run by Gazi University 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 29 Oct 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?
Change in Perioperative (State) Anxiety Level, assessed by the State-Trait Anxiety Inventory (STAI) (time frame: From baseline (3 days before surgery) to the morning of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.