HealthyNCT05959876
The Effect of Perineal Care Education on Palliative Care Patient' Relatives
A study testing Training group in people with Healthy, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled study, which includes pre-test and post-test, is to examine the perineum care education given to caregivers of patients with incontinence and being treated in a palliative care clinic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2023to 1 Sep 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Who agreed to participate in the study
- Hhose mother tongue is Turkish,
- 18 years old and over
- Able to read and write
Who cannot join
- Who refused to participate in the study
- Native language is not Turkish
- Illiterate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University
Bolu, Bolu, 14000
About this study
Official title: The Effect of Training on Perineal Care of Palliative Care Patients With Incontinence on the Knowledge Level of Relatives: A Randomized Controlled Study
The aim of this randomized controlled study, which includes pre-test and post-test, is to examine the perineum care education given to caregivers of patients with incontinence and being treated in a palliative care clinic.
The basic question it aims to answer is:
Read more
Does the perineum care training given to the relatives of patients treated in the palliative care clinic have an effect on the level of knowledge about perineum care?
Participants will participate in a training activity on perineum care. Researchers will compare whether perineum care training given to relatives of palliative care patients is effective compared to the routine service operation, by using lecture, question-answer and presentation method.
Read the detailed description
A time period suitable for the clinic, patient and companion will be determined by making one-to-one interviews with the companions in the experimental and control groups. Care will be taken to make the applications outside of treatment, visit, care, meal and visitor hours. Accompanying attendants will be met at the specified time and information about the work will be given.
Participants in the control group will be given a Personal Information Form and a Perineum Care Knowledge Test as a pre-test and will be given sufficient time to complete them. The participants in the control group will not be interfered with by the researcher during the research. At the end of the same day, the Perineum Care Knowledge Test will be redistributed and collected as a posttest to the control group. This group will only receive routine nursing training given in the hospital. In palliative care clinics, nurses provide information to patients and their families to help patients maintain their independence and control and make choices during their daily care. In addition, trainings are planned for the needs of the patient and his family. After the research process is completed, a handbook on perineal care will be distributed to the participants in the control group by the researcher.
The participants in the experimental group will be given a Personal Information Form and a Perineum Care Knowledge Test as a pre-test and will be given sufficient time to fill them out. Face-to-face and one-to-one perineal care training will be given to the participants in the experimental group. During the trainings, the presentation prepared in the power point program and the content of perineum care will be conveyed by the researcher in two 30-minute sessions using plain lecture, case study and question and answer techniques. These techniques used are considered to be effective methods in the education of patients and their relatives. Opinions were received from three field experts regarding the content validity of the content of perineal care (CGI: 1.00). The Perineum Care Knowledge Test will be redistributed and collected as a posttest upon completion of the training.
- Conditions
- Healthy
- Being tested
- Training group, Control group
- Keywords
- Perineum Care, Caregiver Education, Palliative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training groupOther
Face-to-face perineal care training
Control groupOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Face-to-face perineal care training will be given to the relatives of the patients in the training group in the determined common time period. During the trainings, the presentation prepared in the power point program and the content of perineum care will be conveyed by the researcher in two 30-minute sessions using plain lecture, case study and question and answer techniques. Receives: Other: Training group |
| Control group | Active comparator | The participants in the control group will not be interfered with by the researcher during the research. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palliative care patient relatives' perineum care information: First test
"Perineum Care Knowledge Test" is a test prepared by researchers in line with the literature and sent to an expert academician to ensure content validity. The Perineum Care Knowledge Test is a 3-likert-type questionnaire consisting of a total of 15 questions coded as true, false, I don't know. The minimum score to be obtained from the test is 0 and the maximum score is 15. A high score at the end of the evaluation indicates that the relatives of the patients have a high level of knowledge about perineal care, while a low score indicates a low level of knowledge.
Measured: Just before training
Secondary outcomes (1)
Perineal care information of palliative care patient relatives: Second test
"Perineum Care Knowledge Test" is a test prepared by researchers in line with the literature and sent to an expert academician to ensure content validity. The Perineum Care Knowledge Test is a 3-likert-type questionnaire consisting of a total of 15 questions coded as true, false, I don't know. The minimum score to be obtained from the test is 0 and the maximum score is 15. A high score at the end of the evaluation indicates that the relatives of the patients have a high level of knowledge about perineal care, while a low score indicates a low level of knowledge.
Measured: Immediately after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start5 Aug 2023
- Primary completion5 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized controlled study with experimental and control groups consisting of pre-test and post-test
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lutfiye Nur Uzun, Abant Izzet Baysal University
- Investigators
- Lütfiye Nur Uzun, PhD, Principal investigator, Bolu Abant İzzet Baysal University Faculty of Health Sciences Nursing DepartmentHümeyra Hançer Tok, PhD, Principal investigator, Bolu Abant İzzet Baysal University Faculty of Health Sciences Nursing Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959876
- Sponsor's protocol ID
- AIBU-HEM-UZUN-003
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training on Perineal Care of Palliative Care Patients With Incontinence on the Knowledge Level of Relatives: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05959876
- Acronym / sponsor ID
- AIBU-HEM-UZUN-003
- Conditions
- Healthy
- Keywords
- Perineum Care, Caregiver Education, Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 25 Jul 2023 (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 randomized controlled study, which includes pre-test and post-test, is to examine the perineum care education given to caregivers of patients with incontinence and being treated in a palliative care clinic.
The basic question it aims to answer is:
Does the perineum care training given to the relatives of patients treated in the palliative care clinic have an effect on the level of knowledge about perineum care?
Participants will participate in a training activity on perineum care. Researchers will compare whether perineum care training given to relatives of palliative care patients is effective compared to the routine service operation, by using lecture, question-answer and presentation method.
Detailed description
A time period suitable for the clinic, patient and companion will be determined by making one-to-one interviews with the companions in the experimental and control groups. Care will be taken to make the applications outside of treatment, visit, care, meal and visitor hours. Accompanying attendants will be met at the specified time and information about the work will be given.
Participants in the control group will be given a Personal Information Form and a Perineum Care Knowledge Test as a pre-test and will be given sufficient time to complete them. The participants in the control group will not be interfered with by the researcher during the research. At the end of the same day, the Perineum Care Knowledge Test will be redistributed and collected as a posttest to the control group. This group will only receive routine nursing training given in the hospital. In palliative care clinics, nurses provide information to patients and their families to help patients maintain their independence and control and make choices during their daily care. In addition, trainings are planned for the needs of the patient and his family. After the research process is completed, a handbook on perineal care will be distributed to the participants in the control group by the researcher.
The participants in the experimental group will be given a Personal Information Form and a Perineum Care Knowledge Test as a pre-test and will be given sufficient time to fill them out. Face-to-face and one-to-one perineal care training will be given to the participants in the experimental group. During the trainings, the presentation prepared in the power point program and the content of perineum care will be conveyed by the researcher in two 30-minute sessions using plain lecture, case study and question and answer techniques. These techniques used are considered to be effective methods in the education of patients and their relatives. Opinions were received from three field experts regarding the content validity of the content of perineal care (CGI: 1.00). The Perineum Care Knowledge Test will be redistributed and collected as a posttest upon completion of the training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized controlled study with experimental and control groups consisting of pre-test and post-test
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Training groupFace-to-face perineal care training will be given to the relatives of the patients in the training group in the determined common time period. During the trainings, the presentation prepared in the power point program and the content of perineum care will be conveyed by the researcher in two 30-minute sessions using plain lecture, case study and question and answer techniques. |
| Control group | Active comparator | Other: Control groupThe participants in the control group will not be interfered with by the researcher during the research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Who agreed to participate in the study
- Hhose mother tongue is Turkish,
- 18 years old and over
- Able to read and write
Key exclusion criteria (3 listed)
- Who refused to participate in the study
- Native language is not Turkish
- Illiterate
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 |
|---|---|---|
| Training groupFace-to-face perineal care training | Other | Training group |
| Control groupNo intervention | Other | Control group |
Primary outcome
Palliative care patient relatives' perineum care information: First test
Time frame: Just before training
"Perineum Care Knowledge Test" is a test prepared by researchers in line with the literature and sent to an expert academician to ensure content validity. The Perineum Care Knowledge Test is a 3-likert-type questionnaire consisting of a total of 15 questions coded as true, false, I don't know. The minimum score to be obtained from the test is 0 and the maximum score is 15. A high score at the end of the evaluation indicates that the relatives of the patients have a high level of knowledge about perineal care, while a low score indicates a low level of knowledge.
1 secondary outcome
Perineal care information of palliative care patient relatives: Second test
Time frame: Immediately after training
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 24 Jun 2026.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers.
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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.
Lütfiye Nur Uzun, PhD principal investigator
Bolu Abant İzzet Baysal University Faculty of Health Sciences Nursing Department
Hümeyra Hançer Tok, PhD principal investigator
Bolu Abant İzzet Baysal University Faculty of Health Sciences Nursing Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training group in people with Healthy, run by Abant Izzet Baysal 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 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 24 Jun 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?
Palliative care patient relatives' perineum care information: First test (time frame: Just before training). 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 24 Jun 2026.