NCT07851285

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Sep 2026Dec 2026

Study Start

First participant enrolled

September 15, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 25, 2026

Last Update Submit

September 25, 2026

Conditions

Keywords

Teach-Back MethodPilonidal Sinus SurgeryPatient ComfortPostoperative PainSelf-Care AgencyDischarge Education

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and 10 days after discharge

Secondary Outcomes (1)

  • Change in Pain Intensity

    Baseline and 10 days after discharge

Study Arms (2)

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.

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.

Behavioral: Routine Discharge Education

Interventions

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.

Teach-Back-Supported 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.

Routine Discharge Education

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Buyukcekmece Mimar Sinan State Hospital

Istanbul, 34100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • fatma eti aslan

    Bahcesehir

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants and the researcher delivering the intervention will not be blinded due to the nature of the educational intervention. Statistical analyses will be performed by an independent statistician blinded to the group codes.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 1, 2026

Study Start

September 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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

Locations