NCT04669275

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

November 29, 2020

Last Update Submit

September 5, 2023

Conditions

Keywords

Telephone consultationGastritisPainQuality of sleep

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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

    At the beginning and at the 7th week

Study Arms (2)

telephone counseling

EXPERIMENTAL

People receiving telephone counselling.

Behavioral: Telephone Counselıng

telephone counselin

EXPERIMENTAL

People receiving telephone counselling.

Behavioral: Telephone Counselıng

Interventions

Telephone counseling

telephone counselintelephone counseling

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Eskişehir, 26040, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

GastritisPainSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Nedret Tekin Kaya

    Researcher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

November 29, 2020

First Posted

December 16, 2020

Study Start

November 11, 2020

Primary Completion

January 11, 2021

Study Completion

May 20, 2021

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Study protocol, informed consent form

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
for 5 years
Access Criteria
You can access it by clicking the link. https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp
More information

Locations