Pilonidal Sinus DiseaseTB-PSSNCT07851285
Teach-Back Discharge Education After Pilonidal Sinus Surgery
A study testing Teach-Back-Supported Discharge Education and Routine Discharge Education in people with Pilonidal Sinus Disease and Pilonidal Sinus Treatment, run by Halic University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pilonidal Sinus Disease, Pilonidal Sinus Treatment
- What is being tested?
- Teach-Back-Supported Discharge Education and Routine Discharge Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Buyukcekmece Mimar Sinan State Hospital
Istanbul, 34100
kübra can, MSc, +90 543 8711795, kubracan@halic.edu.tr
gaye mutlu, MSc, +90 534 5132197, gayeeemutluuu@gmail.com
About this study
Official title: The Effect of Teach-Back-Supported Discharge Education on Self-Care Agency, Pain, and Comfort Levels After Pilonidal Sinus Surgery: A Randomized Controlled Trial
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.
- Conditions
- Pilonidal Sinus Disease, Pilonidal Sinus Treatment
- Being tested
- Teach-Back-Supported Discharge Education, Routine Discharge Education
- Keywords
- Teach-Back Method, Pilonidal Sinus Surgery, Patient Comfort, Postoperative Pain, Self-Care Agency, Discharge Education
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach-Back-Supported Discharge EducationBehavioural
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.
Routine Discharge EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Teach-Back-Supported Discharge Education | Experimental | 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. Receives: Behavioral: Teach-Back-Supported Discharge Education |
| Routine Discharge Education | Active comparator | 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. Receives: Behavioral: Routine Discharge Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 10 days after discharge
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.
Measured: 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.
Measured: Baseline and 10 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal Sinus DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the Teach-Back-supported discharge education group or the routine discharge education control group.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- fatma eti aslan, Study chair, Bahcesehir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851285
- Sponsor's protocol ID
- HALIC-2026-634
- Acronym
- TB-PSS
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Teach-Back-Supported Discharge Education on Self-Care Agency, Pain, and Comfort Levels After Pilonidal Sinus Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07851285
- Acronym / sponsor ID
- TB-PSS / HALIC-2026-634
- Conditions
- Pilonidal Sinus Disease, Pilonidal Sinus Treatment
- Keywords
- Teach-Back Method, Pilonidal Sinus Surgery, Patient Comfort, Postoperative Pain, Self-Care Agency, Discharge Education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the Teach-Back-supported discharge education group or the routine discharge education control group.
| Arm | Type | Receives |
|---|---|---|
| Teach-Back-Supported Discharge Education | Experimental | Behavioral: Teach-Back-Supported Discharge EducationParticipants 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. |
| Routine Discharge Education | Active comparator | Behavioral: Routine Discharge EducationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
- -
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 |
|---|---|---|
| Teach-Back-Supported Discharge EducationParticipants 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. | Behavioural | Teach-Back-Supported Discharge Education |
| Routine Discharge EducationParticipants 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. | Behavioural | Routine Discharge Education |
Primary outcome
Change in Self-Care Agency Score
Time frame: Baseline and 10 days after discharge
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.
Change in General Comfort Score
Time frame: Baseline and 10 days after discharge
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.
1 secondary outcome
Change in Pain Intensity
Time frame: Baseline and 10 days after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: 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.
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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.
fatma eti aslan study chair
Bahcesehir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teach-Back-Supported Discharge Education and Routine Discharge Education in people with Pilonidal Sinus Disease and Pilonidal Sinus Treatment, run by Halic 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 2 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: opening soon, as of the sponsor's last update on 1 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kübra can, MSc (+90 5438711795, kubracan@halic.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Care Agency Score (time frame: Baseline and 10 days after discharge). 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 1 Oct 2026.