Perianal FistulaNCT07914530
Video-Based Preoperative Education for Anxiety in Patients Undergoing Anal Fistula Surgery
A study testing Video-Based Perioperative Education in people with Perianal Fistula and Anxiety, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated whether video-based education before surgery could reduce anxiety and improve early recovery in patients undergoing anal fistula surgery under spinal anesthesia. A total of 72 adult patients participated in this randomized controlled trial. Participants were randomly assigned to one of two groups. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Perianal Fistula, Anxiety
- What is being tested?
- Video-Based Perioperative Education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 30 Aug 2026
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-70 years.
- Patients scheduled for elective anal fistula surgery under spinal anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Ability to provide written informed consent.
Who cannot join
- Active psychiatric disorder requiring treatment.
- Clinically relevant cognitive impairment.
- Inability to understand Turkish or complete the study questionnaires.
- Severe visual or hearing impairment preventing participation in the educational intervention.
- Contraindication to spinal anesthesia.
- Chronic opioid use.
- Inability to provide informed consent.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University Hospital
Afyonkarahisar, 03300
About this study
Official title: Effect of Video-Based Perioperative Education on Preoperative Anxiety and Early Perioperative Outcomes in Patients Undergoing Anal Fistula Surgery: A Randomized Controlled Trial
This study evaluated whether video-based education before surgery could reduce anxiety and improve early recovery in patients undergoing anal fistula surgery under spinal anesthesia.
A total of 72 adult patients participated in this randomized controlled trial. Participants were randomly assigned to one of two groups. The intervention group received standard preoperative information and watched an approximately 8-minute educational video explaining spinal anesthesia, the surgical procedure, pain management, and early postoperative recovery. The control group received standard verbal and written information only.
Read more
The main objective was to determine whether video-based education reduced anxiety immediately before surgery, measured using the State-Trait Anxiety Inventory (STAI-S).
The study also evaluated other outcomes, including anxiety measured using another questionnaire (APAIS), postoperative pain, pain medication requirements, and patients' willingness to undergo spinal anesthesia again.
The study aimed to investigate whether adding a short educational video to routine preoperative counseling could improve patients' psychological preparation and early perioperative experience.
- Conditions
- Perianal Fistula, Anxiety
- Being tested
- Video-Based Perioperative Education
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Based Perioperative EducationOther
Participants in the intervention group received routine verbal and written preoperative information followed by an approximately 8-minute standardized animated educational video developed by the general surgery and anesthesiology teams. The video covered spinal anesthesia, patient positioning, monitoring, expected sensory and motor effects, perioperative sensations, general steps of anal fistula surgery, postoperative pain management, early mobilization, and recovery. The video was viewed once on a tablet device in a quiet preoperative area. Preoperative anxiety was reassessed approximately 30 minutes after the intervention using the STAI-S and APAIS questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Video-Based Perioperative Education | Other | Not described Receives: Other: Video-Based Perioperative Education |
| Standard Preoperative Education | Other | Not described Receives: Other: Video-Based Perioperative Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety Measured by the State-Trait Anxiety Inventory (STAI-S)
Preoperative anxiety was assessed using the State-Trait Anxiety Inventory-State (STAI-S), a 20-item questionnaire with scores ranging from 20 to 80. Higher scores indicate greater anxiety. The primary outcome was the immediate preoperative STAI-S score, compared between groups after adjustment for baseline STAI-S.
Measured: Approximately 30 minutes after the educational intervention, before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start15 Nov 2025
- Primary completion30 Aug 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal FistulaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamil Taşkapılı, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914530
- Sponsor's protocol ID
- AFSU/2025-14
- Status last verified
- Nov 2025
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Video-Based Perioperative Education on Preoperative Anxiety and Early Perioperative Outcomes in Patients Undergoing Anal Fistula Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07914530
- Acronym / sponsor ID
- AFSU/2025-14
- Conditions
- Perianal Fistula, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 3 Nov 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.
This study evaluated whether video-based education before surgery could reduce anxiety and improve early recovery in patients undergoing anal fistula surgery under spinal anesthesia.
A total of 72 adult patients participated in this randomized controlled trial. Participants were randomly assigned to one of two groups. The intervention group received standard preoperative information and watched an approximately 8-minute educational video explaining spinal anesthesia, the surgical procedure, pain management, and early postoperative recovery. The control group received standard verbal and written information only.
The main objective was to determine whether video-based education reduced anxiety immediately before surgery, measured using the State-Trait Anxiety Inventory (STAI-S).
The study also evaluated other outcomes, including anxiety measured using another questionnaire (APAIS), postoperative pain, pain medication requirements, and patients' willingness to undergo spinal anesthesia again.
The study aimed to investigate whether adding a short educational video to routine preoperative counseling could improve patients' psychological preparation and early perioperative experience.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-Based Perioperative Education | Other | Other: Video-Based Perioperative Education |
| Standard Preoperative Education | Other | Other: Video-Based Perioperative Education |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-70 years.
- Patients scheduled for elective anal fistula surgery under spinal anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Ability to provide written informed consent.
Key exclusion criteria (8 listed)
- Active psychiatric disorder requiring treatment.
- Clinically relevant cognitive impairment.
- Inability to understand Turkish or complete the study questionnaires.
- Severe visual or hearing impairment preventing participation in the educational intervention.
- Contraindication to spinal anesthesia.
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 |
|---|---|---|
| Video-Based Perioperative EducationParticipants in the intervention group received routine verbal and written preoperative information followed by an approximately 8-minute standardized animated educational video developed by the general surgery and anesthesiology teams. The video covered spinal anesthesia, patient positioning, monitoring, expected sensory and motor effects, perioperative sensations, general steps of anal fistula surgery, postoperative pain management, early mobilization, and recovery. The video was viewed once on a tablet device in a quiet preoperative area. Preoperative anxiety was reassessed approximately 30 minutes after the intervention using the STAI-S and APAIS questionnaires. | Other | Standard Preoperative Education, Video-Based Perioperative Education |
Primary outcome
Preoperative Anxiety Measured by the State-Trait Anxiety Inventory (STAI-S)
Time frame: Approximately 30 minutes after the educational intervention, before surgery
Preoperative anxiety was assessed using the State-Trait Anxiety Inventory-State (STAI-S), a 20-item questionnaire with scores ranging from 20 to 80. Higher scores indicate greater anxiety. The primary outcome was the immediate preoperative STAI-S score, compared between groups after adjustment for baseline STAI-S.
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 3 Nov 2026.
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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 Video-Based Perioperative Education in people with Perianal Fistula and Anxiety, run by Afyonkarahisar Health Sciences 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 4 inclusion and 8 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 3 Nov 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?
Preoperative Anxiety Measured by the State-Trait Anxiety Inventory (STAI-S) (time frame: Approximately 30 minutes after the educational intervention, before surgery). 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 3 Nov 2026.