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Not yet recruitingNCT07851285TB-PSSUpdated Oct 1, 2026

Teach-Back Discharge Education After Pilonidal Sinus Surgery

An interventional study of Teach-Back-Supported Discharge Education and Routine Discharge Education in Pilonidal Sinus Disease and Pilonidal Sinus Treatment, sponsored by Halic University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

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

Updated Oct 1, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This randomized controlled trial will evaluate the effect of Teach-Back-supported discharge education on self-care agency, pain intensity, and comfort levels in patients undergoing surgery for pilonidal sinus disease. A total of 68 participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive discharge education using the Teach-Back method, while the control group will receive routine discharge education and standard care. Self-care agency, pain intensity, and comfort levels will be assessed at baseline and on the tenth day after discharge.

Read the detailed description

This study is designed as a parallel-group randomized controlled trial and will be conducted at Istanbul Büyükçekmece Mimar Sinan State Hospital. The study will include 68 adult patients aged 18-64 years who undergo elective surgery for pilonidal sinus disease. Participants will be randomly assigned to the intervention group or the control group in a 1:1 ratio using block randomization with variable block sizes. Allocation concealment will be ensured through sequentially numbered, opaque, sealed envelopes.

Before the intervention, participants in both groups will complete the Patient Information Form, Exercise of Self-Care Agency Scale, General Comfort Questionnaire, and Visual Analog Scale for pain. Participants in the intervention group will receive Teach-Back-supported discharge education covering wound care, personal hygiene, pain management, sitting and mobility, activities of daily living, bowel elimination, signs of complications, and situations requiring medical consultation. Participants will be asked to explain the information in their own words, and any misunderstood or incomplete information will be clarified until correct understanding is demonstrated. Participants in the control group will receive the hospital's routine discharge education and standard care. All outcome measures will be repeated during the follow-up visit on the tenth day after discharge.

02

Conditions studied

  • Pilonidal Sinus Disease
  • Pilonidal Sinus Treatment

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Keywords

  • Teach-Back Method
  • Pilonidal Sinus Surgery
  • Patient Comfort
  • Postoperative Pain
  • Self-Care Agency
  • Discharge Education
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 68 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Halic University is the lead sponsor of 80 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Being between 18 and 64 years of age Having undergone elective surgery for pilonidal sinus disease Being clinically stable after surgery Being able to read and understand Turkish and communicate verbally in Turkish Having no cognitive, hearing, or visual impairment severe enough to prevent participation in the education process or completion of the data collection forms Being scheduled to attend the follow-up visit on the tenth day after discharge Volunteering to participate in the study and providing written informed consent

Exclusion criteria

Exclusion Criteria:

Being 65 years of age or older Having undergone emergency surgery for pilonidal sinus disease Having undergone another surgical procedure during the same operative session in addition to pilonidal sinus surgery Having previously undergone pilonidal sinus surgery and being reoperated on because of recurrence Requiring postoperative intensive care or being clinically unsuitable to participate in the education Having a diagnosed severe cognitive disorder, psychiatric disorder, or neurological condition that prevents effective communication Being unable to communicate in Turkish Having a physical or cognitive impairment that prevents independent management of self-care and the discharge process Being unable to complete the scales or data collection forms used in the study

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05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Teach-Back-Supported Discharge Education

    Participants will receive Teach-Back-supported discharge education in addition to standard care. The education will cover wound care, personal hygiene, pain management, sitting and mobility, activities of daily living, bowel elimination, signs of complications, and situations requiring medical consultation. Participants will be asked to repeat the information in their own words, and misunderstood or incomplete information will be explained again.

    Behavioral: Teach-Back-Supported Discharge Education

  • Active comparator
    Routine Discharge Education

    Participants will receive the hospital's routine discharge education and standard postoperative care. No additional education based on the Teach-Back method will be provided by the researchers.

    Behavioral: Routine Discharge Education

Interventions

  • BehavioralTeach-Back-Supported Discharge Education

    Participants will receive individualized discharge education using the Teach-Back method. The education will cover wound care, personal hygiene, pain management, sitting and mobility, activities of daily living, bowel elimination, signs of complications, and situations requiring medical consultation. Participants will be asked to explain the information in their own words. Any misunderstood or incomplete information will be clarified and reassessed until correct understanding is demonstrated.

  • BehavioralRoutine Discharge Education

    Participants will receive the hospital's routine discharge education and standard postoperative care. No additional education using the Teach-Back method will be provided by the researchers.

06

What researchers measure

Primary outcomes

  1. Change in Self-Care Agency Score

    Self-care agency will be assessed using the Exercise of Self-Care Agency Scale. The scale consists of 35 items scored from 0 to 4, with a total score ranging from 0 to 140. Higher scores indicate greater self-care agency. The change in scores from baseline to the tenth day after discharge will be compared between the intervention and control groups.

    Time frame: Baseline and 10 days after discharge

  2. Change in General Comfort Score

    General comfort will be assessed using the General Comfort Questionnaire. The questionnaire consists of 48 items evaluating physical, psychospiritual, sociocultural, and environmental dimensions of comfort. Higher scores indicate a higher level of comfort. The change in scores from baseline to the tenth day after discharge will be compared between the intervention and control groups.

    Time frame: Baseline and 10 days after discharge

Secondary outcomes

  1. Change in Pain Intensity

    Pain intensity will be assessed using a 10-centimeter Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. The change in pain scores from baseline to the tenth day after discharge will be compared between the intervention and control groups.

    Time frame: Baseline and 10 days after discharge

07

Study locations

1 site
  • Istanbul Buyukcekmece Mimar Sinan State Hospital
    Istanbul, 34100, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: No — There is currently no plan to share individual participant data. Study findings will be reported in aggregate form to protect participant privacy and confidentiality.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 1, 2026
Show all 1 update
  1. Oct 1, 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
NCT07851285
Lead sponsor
Halic University
Responsible party
Sponsor
First posted
Oct 1, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 1, 2026

Study contacts

Kübra can, MSc
Contact
kubracan@halic.edu.tr
+90 5438711795
fatma eti aslan
study chair · Bahcesehir

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 not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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