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Telephone Counseling in the Education of the Patient With Gastritis

Primary Purpose

Telenursing

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telephone Counselıng
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Telenursing focused on measuring Telephone consultation, Gastritis, Pain, Quality of sleep

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Eskisehir Osmangazi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

telephone counseling

telephone counselin

Arm Description

People receiving telephone counselling.

People receiving telephone counselling.

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
November 29, 2020
Last Updated
September 5, 2023
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04669275
Brief Title
Telephone Counseling in the Education of the Patient With Gastritis
Official Title
The Effect Of Telephone Counselıng On Paın And Sleep Qualıty In Patıents Wıth Gastrıtıs Who Are Traıned In Gastrıtıs Management
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
January 11, 2021 (Actual)
Study Completion Date
May 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telenursing
Keywords
Telephone consultation, Gastritis, Pain, Quality of sleep

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
telephone counseling
Arm Type
Experimental
Arm Description
People receiving telephone counselling.
Arm Title
telephone counselin
Arm Type
Experimental
Arm Description
People receiving telephone counselling.
Intervention Type
Behavioral
Intervention Name(s)
Telephone Counselıng
Intervention Description
Telephone counseling
Primary Outcome Measure Information:
Title
Change in the Visual Analog Skala Pain Scale, according to the initial measurement
Description
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.
Time Frame
At the beginning and at the 7th week
Title
Change in the Richards - Campbell Sleep Scale, according to the initial measurement
Description
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.
Time Frame
At the beginning and at the 7th week
Title
Change in upper Gastrointestinal Symptom Severity Scale according to initial measurement
Description
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
Time Frame
At the beginning and at the 7th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nedret Tekin Kaya
Organizational Affiliation
Researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskisehir Osmangazi University
City
Eskişehir
State/Province
Eskisehir
ZIP/Postal Code
26040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol, informed consent form
IPD Sharing Time Frame
for 5 years
IPD Sharing Access Criteria
You can access it by clicking the link. https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp
IPD Sharing URL
https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp

Learn more about this trial

Telephone Counseling in the Education of the Patient With Gastritis

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