Over 18 Years OldNCT07289841
Discharge Checklist for Stoma Management Skills
A study testing Stoma Management Skills Discharge Checklist used in people with Over 18 Years Old, run by Neslihan Özcanarslan at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to develop an Ostomy Management Skills Discharge Checklist and to prospectively compare individuals who received this list with those who received standard discharge training to monitor its impact on ostomy compliance and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Over 18 Years Old
- What is being tested?
- Stoma Management Skills Discharge Checklist used
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 10 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old
- Patients with a new stoma
- Admitted to General Surgery, Gastrointestinal Surgery, or Surgical Oncology departments
- Discharged with only a stoma
- Without comorbidities
- Alive after surgery
- Able to independently manage their stoma care
Who cannot join
- Visual impairments (e.g., partial blindness, advanced cataracts)
- Physical impairments (e.g., tremors, Parkinson's disease, stroke)
- Intellectual disabilities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin Şehir Eğitim ve Araştırma Hastanesi
Mersin, Yenişehir, 33100
About this study
Official title: Integration of Ostomy Management Skills Discharge Checklist Into Patient Education and Its Effect on Stoma Adaptation and Quality of Life
The aim of this study was to develop an Ostomy Management Skills Discharge Checklist and to prospectively compare individuals who received this list with those who received standard discharge training to monitor its impact on ostomy compliance and quality of life. The study hypotheses were: The developed Stoma Management Skills Discharge Checklist is more effective than standard discharge training in improving ostomy compliance in individuals with stoma.
H1: It is more effective in improving the quality of life in individuals with stoma.
Read the detailed description
This is a quasi-experimental, prospective study to be conducted between December 2025 and March 2026. An analytical approach will be employed. As part of the study, an Ostomy Management Skills Discharge Checklist will be developed, and individuals who received this list will be prospectively compared with those who received standard discharge training to monitor their adaptation to ostomy and their impact on quality of life.This study will be conducted with patients who underwent new intestinal stomas in the General Surgery, Gastroenterology Surgery, and Surgical Oncology departments of Mersin City Training and Research Hospital. Patients will be selected using the purposive sampling method among those who underwent new stomas (colostomies or ileostomies) after surgery. The sample size was calculated based on data from a pilot study with 10 patients using r = 1 (equal sample size for both groups), α = 5%, and 90% power. The sample size was calculated using the formula N = α(Zα/2 + Z1-β)² (r + 1) / r d² (N = (1 + 1) × (1.96 + 0.84)² × 2 × (1.2)² / [1 × (1.6 - 1.4)²]). As a result of the calculation, 32 patients per group were determined for 90% power. A total of 80 patients with new ostomies were included in the study. 40 of these patients will form Group 1, which will be followed with the standard discharge process, and the other 40 will form Group 2, whose discharge is planned based on the Stoma Management Skills Discharge Checklist.
The study provides all patients with the same discharge education. Group 1 receives standard education without a checklist, while Group 2 is evaluated with the Stoma Management Skills Discharge Checklist to objectively assess readiness for discharge. Patients must reach a sufficient level in all checklist steps, and any missing skills are re-taught individually. About one month after discharge, both groups are assessed for ostomy adaptation and quality of life. Data are collected by the surgical unit nurse responsible for ostomy patients through 15-20-minute face-to-face interviews in a quiet room.
Data will be analyzed using IBM SPSS Statistics 22. Frequencies (number, percentage) will be used for categorical variables, and descriptive statistics (mean, standard deviation) for numerical variables. Normality of numerical variables will be assessed through skewness and kurtosis values; values within ±1.5 will be considered normally distributed, therefore parametric tests will be applied. Relationships between two independent categorical variables will be evaluated with the Chi-Square test, and Fisher's Exact test will be used when Chi-Square assumptions are not met. A significance level of 0.05 will be used for all analyses.
- Conditions
- Over 18 Years Old
- Being tested
- Stoma Management Skills Discharge Checklist used
- Keywords
- Skills Discharge Checklist, Adaptation, Discharge, Ostomy, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stoma Management Skills Discharge Checklist usedOther
It is seen that there is no structured discharge checklist that systematically evaluates the knowledge and skill levels of stoma patients during the discharge process and there are no comprehensive studies addressing the impact of such a list on stoma adaptation and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| The group that used the Stoma Management Skills Discharge Checklist. | Experimental | The Stoma Management Skills Discharge Checklist will be used during discharge. Receives: Other: Stoma Management Skills Discharge Checklist used |
| The group that follows the standard discharge process | No intervention | Discharge checklist will not be applied, it will be in the standard discharge process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ostomy Adaptation Scale (OAS)
Description: Ostomy Adaptation Scale (OAS): The Stoma Adaptation Scale (OAS23) is a 23-item self-assessment scale with a Cronbach's alpha coefficient of 0.874, developed to evaluate the level of adaptation to a stoma in individuals with stomas. The scale consists of four sub-sections: acceptance (items 1, 3, 4, 6, 9, 14, 15, 19, 23), anxiety/worry (items 12, 13, 17, 20, 21), anger (items 2 and 10), and social adjustment (items 5, 7, 8, 11). Additionally, three items (16, 18, and 22) do not belong to any sub-section. Each item on this scale is evaluated on a 5-point Likert scale (0-4 points: Strongly agree, Agree, Undecided, Disagree, Strongly disagree). The scale has a minimum score of 0 and a maximum score of 92, with higher scores indicating better overall balance. Twelve items (2, 5, 7, 8, 10, 11, 12, 13, 16, 17, 18, and 21) are reverse-scored due to negative statements.
Measured: Immediately before discharge
Stoma Quality of Life Scale (SQLS)
Description: Developed in 2006, the 21-item SQLS assesses the quality of life of individuals with ostomies. The first two items measure overall life satisfaction, scored from 0 (complete dissatisfaction) to 100 (complete satisfaction). The remaining items are divided into three sub-dimensions: work/social life (6 items), sexuality/body image (5 items), and stoma function (6 items). The scale also includes one item related to economic status and skin irritation, which are not part of any sub-dimension. Except for the first two items, the remaining 19 items in the scale are in a 5-point Likert format (1: never, 2: rarely, 3: sometimes, 4: often, and 5: always). The Turkish adaptation of the scale was carried out by Karadağ et al. in 2011. Confirmatory Factor Analysis (CFA) fit indices of the original scale, consisting of five sub-dimensions and 19 items, showed poor model fit. In conclusion, point 14 (I have concerns about access to stoma care products)
Measured: Immediately before discharge
Secondary outcomes (2)
Ostomy Adaptation Scale (OAS)
Ostomy Adaptation Scale (OAS): The Stoma Adaptation Scale (OAS23) is a 23-item self-assessment scale with a Cronbach's alpha coefficient of 0.874, developed to evaluate the level of adaptation to a stoma in individuals with stomas. The scale consists of four sub-sections: acceptance (items 1, 3, 4, 6, 9, 14, 15, 19, 23), anxiety/worry (items 12, 13, 17, 20, 21), anger (items 2 and 10), and social adjustment (items 5, 7, 8, 11). Additionally, three items (16, 18, and 22) do not belong to any sub-section. Each item on this scale is evaluated on a 5-point Likert scale (0-4 points: Strongly agree, Agree, Undecided, Disagree, Strongly disagree). The scale has a minimum score of 0 and a maximum score of 92, with higher scores indicating better overall balance. Twelve items (2, 5, 7, 8, 10, 11, 12, 13, 16, 17, 18, and 21) are reverse-scored due to negative statements.
Measured: 1 month after discharge
Stoma Quality of Life Scale (SQLS)
Developed in 2006, the 21-item SQLS assesses the quality of life of individuals with ostomies. The first two items measure overall life satisfaction, scored from 0 (complete dissatisfaction) to 100 (complete satisfaction). The remaining items are divided into three sub-dimensions: work/social life (6 items), sexuality/body image (5 items), and stoma function (6 items). The scale also includes one item related to economic status and skin irritation, which are not part of any sub-dimension. Except for the first two items, the remaining 19 items in the scale are in a 5-point Likert format (1: never, 2: rarely, 3: sometimes, 4: often, and 5: always). The Turkish adaptation of the scale was carried out by Karadağ et al. in 2011. Confirmatory Factor Analysis (CFA) fit indices of the original scale, consisting of five sub-dimensions and 19 items, showed poor model fit. In conclusion, point 14 (I have concerns about access to stoma care products).
Measured: 1 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start15 Dec 2025
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Over 18 Years OldStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neslihan Özcanarslan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Neslihan Özcanarslan, Toros University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289841
- Sponsor's protocol ID
- 22.06.2022/129
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Ostomy Management Skills Discharge Checklist Into Patient Education and Its Effect on Stoma Adaptation and Quality of Life
- ClinicalTrials.gov ID
- NCT07289841
- Acronym / sponsor ID
- 22.06.2022/129
- Conditions
- Over 18 Years Old
- Keywords
- Skills Discharge Checklist, Adaptation, Discharge, Ostomy, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Neslihan ÖzcanarslanUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 17 Dec 2025 (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.
The aim of this study was to develop an Ostomy Management Skills Discharge Checklist and to prospectively compare individuals who received this list with those who received standard discharge training to monitor its impact on ostomy compliance and quality of life. The study hypotheses were: The developed Stoma Management Skills Discharge Checklist is more effective than standard discharge training in improving ostomy compliance in individuals with stoma.
H1: It is more effective in improving the quality of life in individuals with stoma.
Detailed description
This is a quasi-experimental, prospective study to be conducted between December 2025 and March 2026. An analytical approach will be employed. As part of the study, an Ostomy Management Skills Discharge Checklist will be developed, and individuals who received this list will be prospectively compared with those who received standard discharge training to monitor their adaptation to ostomy and their impact on quality of life.This study will be conducted with patients who underwent new intestinal stomas in the General Surgery, Gastroenterology Surgery, and Surgical Oncology departments of Mersin City Training and Research Hospital. Patients will be selected using the purposive sampling method among those who underwent new stomas (colostomies or ileostomies) after surgery. The sample size was calculated based on data from a pilot study with 10 patients using r = 1 (equal sample size for both groups), α = 5%, and 90% power. The sample size was calculated using the formula N = α(Zα/2 + Z1-β)² (r + 1) / r d² (N = (1 + 1) × (1.96 + 0.84)² × 2 × (1.2)² / [1 × (1.6 - 1.4)²]). As a result of the calculation, 32 patients per group were determined for 90% power. A total of 80 patients with new ostomies were included in the study. 40 of these patients will form Group 1, which will be followed with the standard discharge process, and the other 40 will form Group 2, whose discharge is planned based on the Stoma Management Skills Discharge Checklist.
The study provides all patients with the same discharge education. Group 1 receives standard education without a checklist, while Group 2 is evaluated with the Stoma Management Skills Discharge Checklist to objectively assess readiness for discharge. Patients must reach a sufficient level in all checklist steps, and any missing skills are re-taught individually. About one month after discharge, both groups are assessed for ostomy adaptation and quality of life. Data are collected by the surgical unit nurse responsible for ostomy patients through 15-20-minute face-to-face interviews in a quiet room.
Data will be analyzed using IBM SPSS Statistics 22. Frequencies (number, percentage) will be used for categorical variables, and descriptive statistics (mean, standard deviation) for numerical variables. Normality of numerical variables will be assessed through skewness and kurtosis values; values within ±1.5 will be considered normally distributed, therefore parametric tests will be applied. Relationships between two independent categorical variables will be evaluated with the Chi-Square test, and Fisher's Exact test will be used when Chi-Square assumptions are not met. A significance level of 0.05 will be used for all analyses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group that used the Stoma Management Skills Discharge Checklist. | Experimental | Other: Stoma Management Skills Discharge Checklist usedThe Stoma Management Skills Discharge Checklist will be used during discharge. |
| The group that follows the standard discharge process | No intervention | –Discharge checklist will not be applied, it will be in the standard discharge process |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over 18 years old
- Patients with a new stoma
- Admitted to General Surgery, Gastrointestinal Surgery, or Surgical Oncology departments
- Discharged with only a stoma
- Without comorbidities
Key exclusion criteria (3 listed)
- Visual impairments (e.g., partial blindness, advanced cataracts)
- Physical impairments (e.g., tremors, Parkinson's disease, stroke)
- Intellectual disabilities
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 |
|---|---|---|
| Stoma Management Skills Discharge Checklist usedIt is seen that there is no structured discharge checklist that systematically evaluates the knowledge and skill levels of stoma patients during the discharge process and there are no comprehensive studies addressing the impact of such a list on stoma adaptation and quality of life. | Other | The group that used the Stoma Management Skills Discharge Checklist. |
Primary outcome
Ostomy Adaptation Scale (OAS)
Time frame: Immediately before discharge
Description: Ostomy Adaptation Scale (OAS): The Stoma Adaptation Scale (OAS23) is a 23-item self-assessment scale with a Cronbach's alpha coefficient of 0.874, developed to evaluate the level of adaptation to a stoma in individuals with stomas. The scale consists of four sub-sections: acceptance (items 1, 3, 4, 6, 9, 14, 15, 19, 23), anxiety/worry (items 12, 13, 17, 20, 21), anger (items 2 and 10), and social adjustment (items 5, 7, 8, 11). Additionally, three items (16, 18, and 22) do not belong to any sub-section. Each item on this scale is evaluated on a 5-point Likert scale (0-4 points: Strongly agree, Agree, Undecided, Disagree, Strongly disagree). The scale has a minimum score of 0 and a maximum score of 92, with higher scores indicating better overall balance. Twelve items (2, 5, 7, 8, 10, 11, 12, 13, 16, 17, 18, and 21) are reverse-scored due to negative statements.
Stoma Quality of Life Scale (SQLS)
Time frame: Immediately before discharge
Description: Developed in 2006, the 21-item SQLS assesses the quality of life of individuals with ostomies. The first two items measure overall life satisfaction, scored from 0 (complete dissatisfaction) to 100 (complete satisfaction). The remaining items are divided into three sub-dimensions: work/social life (6 items), sexuality/body image (5 items), and stoma function (6 items). The scale also includes one item related to economic status and skin irritation, which are not part of any sub-dimension. Except for the first two items, the remaining 19 items in the scale are in a 5-point Likert format (1: never, 2: rarely, 3: sometimes, 4: often, and 5: always). The Turkish adaptation of the scale was carried out by Karadağ et al. in 2011. Confirmatory Factor Analysis (CFA) fit indices of the original scale, consisting of five sub-dimensions and 19 items, showed poor model fit. In conclusion, point 14 (I have concerns about access to stoma care products)
2 secondary outcomes
Ostomy Adaptation Scale (OAS)
Time frame: 1 month after discharge
Stoma Quality of Life Scale (SQLS)
Time frame: 1 month after discharge
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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 Stoma Management Skills Discharge Checklist used in people with Over 18 Years Old, run by Neslihan Özcanarslan 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 7 inclusion and 3 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 13 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?
Ostomy Adaptation Scale (OAS) (time frame: Immediately before 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 13 Oct 2026.