TelenursingNCT04669275
Telephone Counseling in the Education of the Patient With Gastritis
A study testing Telephone Counselıng in people with Telenursing, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
It is planned to investigate the effect of telephone counseling on pain and sleep quality in patients with gastritis who have received gastritis management training. The individuals who constitute the target group in the planned study will be determined through the records of patients diagnosed with gastritis who… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Telenursing
- What is being tested?
- Telephone Counselıng
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2020to 20 May 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older,
- People with gastritis, pain and sleep problems;
- Without hearing loss,
- Without visual impairment,
- Can speak Turkish,
- Able to communicate by phone,
- Literate
- Patients who voluntarily participated in the study.
Who cannot join
- Being under 18,
- Without gastritis,
- With hearing disabilities,
- With visual disabilities,
- Can not understand and speak Turkish,
- Unable to communicate by phone,
- İlliterate,
- Patients who did not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, Eskişehir, 26040
About this study
Official title: The Effect Of Telephone Counselıng On Paın And Sleep Qualıty In Patıents Wıth Gastrıtıs Who Are Traıned In Gastrıtıs Management
It is planned to investigate the effect of telephone counseling on pain and sleep quality in patients with gastritis who have received gastritis management training. The individuals who constitute the target group in the planned study will be determined through the records of patients diagnosed with gastritis who applied to the Internal Medicine Polyclinic of Çankırı State Hospital. The target group of this study are individuals over the age of 18 diagnosed with gastritis. In the study, 18 years and older, who have Gastritis, have pain and sleep problems; The sample of the study is that patients with hearing loss, visual impairment, inability to understand / speak Turkish, who do not have a communication problem to prevent or prevent education or to participate in the study, who can communicate by phone, who are literate, and who voluntarily participate in the study.
Read the detailed description
ABSTRACT It is planned to investigate the effect of telephone counseling on pain and sleep quality in patients with gastritis who have received gastritis management training. The individuals who constitute the target group in the planned study will be determined through the records of patients diagnosed with gastritis who applied to the Internal Medicine Polyclinic of Çankırı State Hospital. The target group of this study are individuals over the age of 18 diagnosed with gastritis. In the study, 18 years and older, who have Gastritis, have pain and sleep problems; The sample of the study is that patients with hearing loss, visual impairment, inability to understand / speak Turkish, who do not have a communication problem to prevent or prevent education or to participate in the study, who can communicate by phone, who are literate, and who voluntarily participate in the study. Research data will be collected with 7 forms prepared by the researcher.1.form is the elucidated form of consent, 2.form is the Introductory Information Form for determining the socio-demographic characteristics of the individuals who will participate in the research.3.form is the Richards Campbell Sleep Scale. 4. form is the Pain Assessment Scale. 5. Form is the Upper Gastrointestinal System Symptom Severity Scale. 6.form is the Tele Nursing Form for Gastritis Symptoms.7. form is the Telephone Call Evaluation Form.The planned study is an experimental study.The sample will be calculated by power analysis. The study will include an initiative group, a control group. Patients in both the initiative and the control group will be met and informed about the study by the researcher via face-to-face interview after their written and oral consent has been obtained. The first five forms will be applied to the control group and all 8 forms will be applied to the experimental group. The sampling individuals in the experimental group will receive gastritis management training and telephone counseling, while the individuals in the second group will form the control group. In the experimental group, the effect of a comprehensive gastritis management training program and 4 phone counseling and sms reminders one day a week on sleep quality and stomach pain will be evaluated. Phone calls 1. Week 3. Week 5. week and 7. it is weekly and will be performed biweekly.In the control group, no attempt will be made other than the rank given by the doctor. However, when the study is finished, a training booklet will be provided. An email was sent to the experts for the gastritis management training booklet prepared based on the relevant literature. DİSCERN Measurement Tool has also been sent as an e-mail to evaluate together with the booklet. The intervention group will be trained on topics such as reducing gastritis complaints, improving sleep quality, rational drug use, damages of smoking and alcohol, coping with stress, and factors triggering gastritis. Phone calls are expected to be between 12.00-18.00 and approximately 15 minutes.A business card will be printed by the researcher to enable patients to easily access the researcher. During the phone calls, they will be told that they can call on the topics they need between 08:00-20:00 in the evening.The results of the study will be analyzed in computer environment with SPSS program.
- Conditions
- Telenursing
- Being tested
- Telephone Counselıng
- Keywords
- Telephone consultation, Gastritis, Pain, Quality of sleep
- Medical subject headings
- Gastritis, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone CounselıngBehavioural
Telephone counseling
| Study group | Role | What they receive |
|---|---|---|
| telephone counseling | Experimental | People receiving telephone counselling. Receives: Behavioral: Telephone Counselıng |
| telephone counselin | Experimental | People receiving telephone counselling. Receives: Behavioral: Telephone Counselıng |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Visual Analog Skala Pain Scale, according to the initial measurement
The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically to digital. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line or by placing a point or pointing on this line. For example, I have no pain at one end for pain, very severe pain is written on the other end, and the patient marks his current state on this line. The length of the distance from the place where there is no pain to the point marked by the patient indicates the patient's pain.
Measured: At the beginning and at the 7th week
Change in the Richards - Campbell Sleep Scale, according to the initial measurement
There is a chart scored from 0 to 100 for each sleep statement. In this chart, "0" corresponds to the worst case and "100" to the best case for each statement.
Measured: At the beginning and at the 7th week
Change in upper Gastrointestinal Symptom Severity Scale according to initial measurement
Contains questions about the severity of symptoms related to the gastrointestinal problem. For each symptom, the number is chosen that best represents how severe that symptom has been in the past two weeks. 0 = No symptoms, 1 = very mild, 2 = Mild, 3 = Moderate, 4 = Severe; 5 = Very severe
Measured: At the beginning and at the 7th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start11 Nov 2020
- Primary completion11 Jan 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TelenursingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nedret Tekin Kaya, Eskisehir Osmangazi University
- Investigators
- Nedret Tekin Kaya, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669275
- Sponsor's protocol ID
- Eskisehir Osmangazi
- Status last verified
- Sep 2023
- First submitted
- 29 Nov 2020
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, informed consent form
Publications
Tekin Kaya N, Orsal O. "The Effect of Tele-Nursing on Pain and Sleep in Patients With Gastritis". Pain Manag Nurs. 2025 Dec;26(6):e515-e523. doi: 10.1016/j.pmn.2025.06.006. Epub 2025 Jul 8.
PubMed 40634176
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Telephone Counselıng On Paın And Sleep Qualıty In Patıents Wıth Gastrıtıs Who Are Traıned In Gastrıtıs Management
- ClinicalTrials.gov ID
- NCT04669275
- Acronym / sponsor ID
- Eskisehir Osmangazi
- Conditions
- Telenursing
- Keywords
- Telephone consultation, Gastritis, Pain, Quality of sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 16 Dec 2020 (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.
It is planned to investigate the effect of telephone counseling on pain and sleep quality in patients with gastritis who have received gastritis management training. The individuals who constitute the target group in the planned study will be determined through the records of patients diagnosed with gastritis who applied to the Internal Medicine Polyclinic of Çankırı State Hospital. The target group of this study are individuals over the age of 18 diagnosed with gastritis. In the study, 18 years and older, who have Gastritis, have pain and sleep problems; The sample of the study is that patients with hearing loss, visual impairment, inability to understand / speak Turkish, who do not have a communication problem to prevent or prevent education or to participate in the study, who can communicate by phone, who are literate, and who voluntarily participate in the study.
Detailed description
ABSTRACT It is planned to investigate the effect of telephone counseling on pain and sleep quality in patients with gastritis who have received gastritis management training. The individuals who constitute the target group in the planned study will be determined through the records of patients diagnosed with gastritis who applied to the Internal Medicine Polyclinic of Çankırı State Hospital. The target group of this study are individuals over the age of 18 diagnosed with gastritis. In the study, 18 years and older, who have Gastritis, have pain and sleep problems; The sample of the study is that patients with hearing loss, visual impairment, inability to understand / speak Turkish, who do not have a communication problem to prevent or prevent education or to participate in the study, who can communicate by phone, who are literate, and who voluntarily participate in the study. Research data will be collected with 7 forms prepared by the researcher.1.form is the elucidated form of consent, 2.form is the Introductory Information Form for determining the socio-demographic characteristics of the individuals who will participate in the research.3.form is the Richards Campbell Sleep Scale. 4. form is the Pain Assessment Scale. 5. Form is the Upper Gastrointestinal System Symptom Severity Scale. 6.form is the Tele Nursing Form for Gastritis Symptoms.7. form is the Telephone Call Evaluation Form.The planned study is an experimental study.The sample will be calculated by power analysis. The study will include an initiative group, a control group. Patients in both the initiative and the control group will be met and informed about the study by the researcher via face-to-face interview after their written and oral consent has been obtained. The first five forms will be applied to the control group and all 8 forms will be applied to the experimental group. The sampling individuals in the experimental group will receive gastritis management training and telephone counseling, while the individuals in the second group will form the control group. In the experimental group, the effect of a comprehensive gastritis management training program and 4 phone counseling and sms reminders one day a week on sleep quality and stomach pain will be evaluated. Phone calls 1. Week 3. Week 5. week and 7. it is weekly and will be performed biweekly.In the control group, no attempt will be made other than the rank given by the doctor. However, when the study is finished, a training booklet will be provided. An email was sent to the experts for the gastritis management training booklet prepared based on the relevant literature. DİSCERN Measurement Tool has also been sent as an e-mail to evaluate together with the booklet. The intervention group will be trained on topics such as reducing gastritis complaints, improving sleep quality, rational drug use, damages of smoking and alcohol, coping with stress, and factors triggering gastritis. Phone calls are expected to be between 12.00-18.00 and approximately 15 minutes.A business card will be printed by the researcher to enable patients to easily access the researcher. During the phone calls, they will be told that they can call on the topics they need between 08:00-20:00 in the evening.The results of the study will be analyzed in computer environment with SPSS program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telephone counseling | Experimental | Behavioral: Telephone CounselıngPeople receiving telephone counselling. |
| telephone counselin | Experimental | Behavioral: Telephone CounselıngPeople receiving telephone counselling. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years and older,
- People with gastritis, pain and sleep problems;
- Without hearing loss,
- Without visual impairment,
- Can speak Turkish,
Key exclusion criteria (8 listed)
- Being under 18,
- Without gastritis,
- With hearing disabilities,
- With visual disabilities,
- Can not understand and speak Turkish,
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 |
|---|---|---|
| Telephone CounselıngTelephone counseling | Behavioural | telephone counselin, telephone counseling |
Primary outcome
Change in the Visual Analog Skala Pain Scale, according to the initial measurement
Time frame: At the beginning and at the 7th week
The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically to digital. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line or by placing a point or pointing on this line. For example, I have no pain at one end for pain, very severe pain is written on the other end, and the patient marks his current state on this line. The length of the distance from the place where there is no pain to the point marked by the patient indicates the patient's pain.
Change in the Richards - Campbell Sleep Scale, according to the initial measurement
Time frame: At the beginning and at the 7th week
There is a chart scored from 0 to 100 for each sleep statement. In this chart, "0" corresponds to the worst case and "100" to the best case for each statement.
Change in upper Gastrointestinal Symptom Severity Scale according to initial measurement
Time frame: At the beginning and at the 7th week
Contains questions about the severity of symptoms related to the gastrointestinal problem. For each symptom, the number is chosen that best represents how severe that symptom has been in the past two weeks. 0 = No symptoms, 1 = very mild, 2 = Mild, 3 = Moderate, 4 = Severe; 5 = Very severe
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 8 Sep 2023.
- Derived from this study: PubMed 40634176Tekin Kaya N, Orsal O. "The Effect of Tele-Nursing on Pain and Sleep in Patients With Gastritis". Pain Manag Nurs. 2025 Dec;26(6):e515-e523. doi: 10.1016/j.pmn.2025.06.006. Epub 2025 Jul 8.
- Individual participant dataSharing planned: Yes. Study protocol, informed consent form
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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.
Nedret Tekin Kaya principal investigator
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Counselıng in people with Telenursing, run by Eskisehir Osmangazi 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 8 inclusion and 8 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 8 Sep 2023. 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?
Change in the Visual Analog Skala Pain Scale, according to the initial measurement (time frame: At the beginning and at the 7th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04669275, which also lists 1 linked publication.
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 8 Sep 2023.